Drug News

Fasiglifam (Takeda) success in Phase III trial for treatment of Type 2 Diabetes

Takeda Pharmaceutical Company Limited announced results of a Phase III clinical trial (CCT-003) of fasiglifam (TAK-875) for the treatment of Type 2 Diabetes presented at the 56th Annual Meeting of the Japan Diabetes Society.

The results show that 25 mg and 50 mg fasiglifam, when administered once-daily, showed statistically significant and clinically relevant HbA1c lowering effect in ...

NICE recommends Betmiga (Astellas) for patients with Overactive Bladder

The National Institute for Health and Care Excellence ( NICE) in England and Wales has issued final draft guidance recommending Betmiga (mirabegron) from Astellas for reimbursement. The decision follows a provisional recommendation from the institute in March 2013. Betmiga is recommended for overactive bladder syndrome in people unsuited to antimuscarinic drugs because they are contraindicated, clinically ineffective or cause unacceptable ...

Three Phase III studies of Brintellix (Lundbeck/Takeda) for Depression meet primary endpoint

New data from four Phase III studies evaluating effectiveness in treating Depression in patients taking Brintellix (vortioxetine), from Lundbeck and Takeda, shows that three of the four pivotal studies met their primary efficacy endpoint as measured by the change from baseline of the Montgomery-Asberg Depression Rating Scale (MADRS) total score. The studies were multicenter, randomized, double-blind, parallel-group trials in adults, ...

Results positive for Afinitor (Novartis) in BOLERO-3 study in HER2 positive Breast Cancer

Results of a pivotal Phase III trial in women with HER2 positive (HER2+) advanced Breast Cancer showed that Afinitor (everolimus) tablets, from Novartis, in combination with Herceptin (trastuzumab) and vinorelbine significantly extended progression-free survival (PFS) after prior therapy when compared to treatment with placebo plus trastuzumab and vinorelbine, meeting the study's primary endpoint.

Efficacy and safety data from the ...

Study of Prolia (Amgen/GSK) plus teriparatide shows significant benefits in Osteoporosis

A randomised, controlled trial of postmenopausal women with Osteoporosis shows that teriparatide and Prolia (denosumab), from Amgen/GSK, increased bone mineral densification (BMD) better than previously reported with any available treatment. Ninety four postmenopausal women were assigned in a 1:1:1 ratio to receive 20 ug teriparatide daily, 60 mg denosumab every 6 months, or both. BMD was measured at 0, 3, ...

EU Pharmacovigilance Risk Assessment Committee clears Diane 35 (Bayer) for Acne

During its meeting of 13 to 16 May 2013, the EMA Pharmacovigilance Risk Assessment Committee (PRAC) concluded that the benefits of Diane 35 (Bayer HealthCare) and other medicines containing cyproterone acetate 2 mg and ethinylestradiol 35 micrograms continue to outweigh their risks for the treatment of moderate to severe Acne related to androgen sensitivity and/or hirsutism (excessive unwanted growth ...

IDMC halts Phase III study of Vargatef (Boehringer) in NSCLC

The LUME-LUNG 2 double-blinded Phase III study evaluating Vargatef (nintedanib), from Boehringer, plus pemetrexed compared to pemetrexed plus placebo in patients with advanced non-squamous NSCLC has been halted at the recommendation of the Independent Data Monitoring Committee after 713 patients had been enrolled. This decision was based on the results of an interim review of efficacy (PFS) for a pre-defined ...

Phase III study of NEPA (Helsinn and Eisai) meets endpoint in patients with Nausea

Top-line results from a pivotal Phase III clinical study investigating NEPA (netupitant and palonosetron), from Helsinn and Eisai, for chemotherapy-induced Nausea and Vomiting (CINV), shows NEPA has superior complete response rates compared with palonosetron during the delayed phase after chemotherapy administration, which was the primary endpoint of the study. The global, randomized, double-blind, parallel group superiority study was designed to ...

Phase III study of Tomtovok (Boehringer) meets endpoint for NSCLC

The LUX-Lung 6 randomized, open-label Phase III trial comparing Tomtovok (afatinib), from Boehringer, to standard chemotherapy in 364 Asian patients with Non Small Cell Lung Cancer has met its primary endpoint. Within the study population, patients treated with afatinib (n=242) lived for a median of 11.0 months before their tumor started to grow again versus 5.6 months for patients treated ...

Phase III trial for N9-GP(Novo Nordisk) treatment for Haemophilia B

Novo Nordisk has announced the completion of PARADIGM 2, the first Phase III trial with a long-acting FIX derivative, N9-GP (glycopegylated recombinant factor IX), for Haemophilia B patients. PARADIGM 2 is a multi-centre, blinded trial evaluating the safety and efficacy of N9-GP when used for on demand or prophylactic treatment in patients with Haemophilia B.

In the trial, ...

SAR 302503 (Sanofi) successs in JAKARTA study of Myelofibrosis

Sanofi has announced that the pivotal study, JAKARTA, examining the selective JAK2 inhibitor SAR 302503 for Myelofibrosis versus placebo in 289 patients, met its primary endpoint in both dose groups. The primary endpoint assessed the proportion of patients achieving >35% reduction of spleen volume. Consistent with data reported in previous trials, the most common adverse events were anemia, diarrhea, ...

FDA approves Xofigo (Bayer HealthCare) for Prostate Cancer

The FDA has approved Xofigo (radium Ra 223 dichloride), from Bayer HealthCare, for the treatment of patients with castration-resistant Prostate Cancer, symptomatic bone metastases and no known visceral metastatic disease. Xofigo (formerly Alpharadin) is the first and only alpha particle-emitting radioactive therapeutic agent approved by the FDA that has demonstrated improvement in overall survival (OS) and delay in time to ...

GA 101 success in Phase III study for treatment of Chronic Lymphocytic Leukemia

The first results are announced by Genentech from CLL11, a Phase III study of the investigational medicine GA 101 (obinutuzumab) which is being conducted in collaboration with the German CLL Study Group (GCLLSG). The CLL11 study compared the combination of either GA 101 or Rituxan (rituximab) and chlorambucil, a standard chemotherapy, to chlorambucil alone in Chronic Lymphocytic Leukemia.

...

Moxetumomab (MedImmune/AstraZeneca) moves into Phase III for Treatment of Hairy Cell Leukemia

MedImmune, AstraZeneca’s global biologics research and development arm, has enrolled the first patient in the Phase III clinical trial for moxetumomab pasudotox. The trial is sponsored by the Cancer Therapy Evaluation Program (CTEP), a programme within the Division of Cancer Treatment and Diagnosis at the US National Cancer Institute, and will evaluate moxetumomab pasudotox as a potential treatment in ...

TaiGen Biotechnology files NDA for antibiotic nemonoxacin in Taiwan and China

TaiGen Biotechnology has submitted an New Drug Application for the oral formulation of nemonoxacin, for Infectious Diseases, with the Taiwan Food and Drug Administration and China Food and Drug Administration. The application is based on a pivotal Phase III trial with 532 patients in community-acquired Pneumonia (CAP).

The trial was conducted in both Taiwan and mainland China (441 patients from ...

FDA approves Tarceva (Genentech/Astellas) for NSCLC as detected by cobas EGFR Mutation Test

Genentech, and Astellas Pharma US, Inc. have announced that the FDA has approved Tarceva (erlotinib) tablets for the initial (first-line) treatment of people with metastatic Non-Small Cell Lung Cancer (NSCLC) whose tumors have certain epidermal growth factor receptor (EGFR) activating mutations as detected by an FDA-approved test.

The FDA also approved the cobas EGFR Mutation Test, which was ...

Seattle Genetics files Adcetris at FDA for extended use in Hodgkin Lymphoma and sALCL

Seattle Genetics, Inc. has announced that the FDA has accepted for filing a supplement to the Biologics License Application (sBLA) supporting the use of Adcetris (brentuximab vedotin) for retreatment and extended duration beyond 16 cycles of therapy in relapsed Hodgkin Lymphoma (HL) and Systemic Anaplastic Large Cell Lymphoma (sALCL). The FDA is expected to take action on the application ...

FDA accepts BLA from Biogen for Eloctate for treatment of Haemophilia A

Biogen Idec has announced that the FDA has accepted the company's Biologics License Application (BLA) for the marketing approval of Eloctate (recombinant factor VIII Fc fusion protein) for the treatment of Haemophilia A. Eloctate is the first Haemophilia A product candidate in a new class of long-lasting clotting factor therapies being developed with the goal of providing long-lasting protection and ...

FDA approves Nymalize (Arbor Pharmaceuticals) for Sub Arachnoid Haemorrhage

The FDA has approved the New Drug Application (NDA) for Nymalize (nimodipine) oral solution, from Arbor Pharmaceuticals, for the improvement of neurological outcome by reducing the incidence and severity of ischemic deficits in adult patients with Sub Arachnoid Haemorrhage. It is the only nimodipine oral solution indicated for the improvement of neurological outcome in adult patients with SAH. The company ...

Succesful Phase III studies with Fycompa (Eisai) for Epilepsy published in Epilepsia

Data from three pivotal Phase III clinical studies of Fycompa (perampanel), from Eisai, shows the drug reduced partial Epilepsy seizure frequency and improved responder rates compared to placebo. The pooled analysis of nearly 1,500 patients in Study 304, 306 and 307 showed that median reductions in partial seizure frequency were greater with perampanel 4 mg (-23·3%), 8 mg (-28·8%), and ...

CE Mark granted for Architectt HbA1c test to diagnose Diabetes

Abbott has announced CE Marking (Conformité Européenne) for the Architect clinical chemistry Hemoglobin A1c (HbA1c) test, which may aid physicians in diagnosing and monitoring diabetes as well as identifying patients at risk for developing diabetes.

The Architect clinical chemistry HbA1c test is available in several countries throughout Europe, Asia, Latin America, Canada and Africa, pending country registration. Abbott ...

Enzastaurin (Eli Lilly) fails Phase III trial for B Cell Lymphoma

Eli Lilly and Company has announced Phase III clinical trial results from enzastaurin's PRELUDE study, which explored the molecule as a monotherapy in the prevention of relapse in patients with diffuse large B-cell lymphoma (DLBCL). The study failed to show a statistically significant increase compared to placebo in disease-free survival in patients at high risk of relapse following rituximab-based ...

FDA approves Ilaris (Novartis) for treatment of Systemic Juvenile Idiopathic Arthritis

Novartis announced that the FDA has on 10 May 2013 approved Ilaris (canakinumab) for the treatment of active Systemic Juvenile Idiopathic Arthritis (SJIA) in patients aged 2 years and older. Ilaris is the first interleukin-1 beta (IL-1 beta) inhibitor approved for SJIA and the only treatment approved specifically for SJIA that is given as a once-monthly subcutaneous injection.

SJIA ...

PROTECT-AF trial of Watchman LAAC (Boston Scientific) successful for Stroke Prevention

Four-year follow-up data from the PROTECT AF clinical trial demonstrated the Watchman Left Atrial Appendage (LAA) Closure device, from Boston Scientific, was statistically superior to warfarin for preventing cardiovascular death, all-cause Stroke and systemic embolization. The data demonstrated significant reductions in both cardiovascular and all death compared to warfarin.

The observed primary efficacy event rate was 2.3 percent and 3.8 ...

Two analyses show Fycompa (Eisai) effective for Epilepsy

Two new analyses on clinical experience with Fycompa (perampanel), from Eisai, show it is effective and well tolerated in patients with difficult-to-treat partial Epilepsy. The results describe the first real life experiences of perampanel as an adjunctive therapy. In the first study, on 45 patients followed up for at least six months, 47% had a reduction in seizure frequency of ...

EU approves Octava Pink test (Eventus Diagnostics) for detecting Breast Cancer

The EU have awarded CE mark approval to the Octava Pink breast cancer test, from Eventus Diagnostics. The test is one of a new class of rapid, accurate and cost-effective blood tests that measure cancer-specific autoantibodies to detect the presence or absence of Breast Cancer. The Octava confirmatory tests are designed to be used in conjunction with annual screening mammograms. ...

FDA approves Ilesto 7 ICD/CRT-D (Biotronik) for patients with Heart Failure

The FDA has granted approval for the Ilesto 7 implantable cardioverter-defibrillator/cardiac resynchronization therapy defibrillator (ICD/CRT-D) series, from Biotronik, for patients who need resynchronisation therapy. The device is one of the world's smallest ICDs and uses ProMRI technology, which enables access to MR scans. Patients also benefit from secure remote monitoring via Biotronik's Home Monitoring system to improve diagnosis. The Ilesto ...

Merck Inc files MK 3641 at FDA for treatment of Ragweed Pollen Allergies

Merck & Co. has announced that the FDA has accepted its biologics license application for MK 3641, a dissolvable tablet to treat Ragweed Pollen Allergies and expects the agency to complete its review in the first half of 2014.

Merck has partnered with ALK-Abello A/S to develop the sublingual allergy immunotherapy tablets for ragweed.

Teva Pharmaceutical Industries will market Adasuve for treatment of agitation in Schizophrenia in the United States

Alexza Pharmaceuticals, Inc. announced that they have entered into an exclusive U.S. license and supply agreement with Teva Pharmaceutical Industries Ltd for Adasuve (Staccato loxapine).

Adasuve is Alexza's first approved product and was approved by the FDA in December 2012 and by the European Medicines Agency in February 2013. Teva Pharmaceutical USA Inc. is Alexza's commercial partner for Adasuve ...

Trial shows Vascazen (Pivotal Therapeutics) effective in altering cholesterol levels in patients with CV Risk

A trial has demonstrated that Vascazen (omega-3 oil), from Pivotal Therapeutics, is highly effective in correcting an omega-3 deficiency. The company suggests this could have benefits for people at risk of developing CardioVascular Disease. In eight weeks of treatment a statistically significant (p<0.0001) increase of 121% in the Omega-Score and 112% (p<0.0001) in Omega-Index (the blood levels of EPA, DHA ...

ASPECCT study of Vectibix (Amgen) compared to Erbitux in treatment of Colorectal Cancer

Amgen announced that the Phase III head-to-head ASPECCT ('763) trial evaluating Vectibix (panitumumab) versus Erbitux (cetuximab) as a single agent for the treatment of chemorefractory metastatic Colorectal Cancer (mCRC) in patients with wild-type KRAS tumors (n=1,010) met its primary endpoint of non-inferiority for overall survival. The estimated overall survival hazard ratio (Vectibix/Erbitux) was 0.966 (95 percent CI: 0.839, 1.113) ...

FDA approves Viva and Evera defibrillators for Heart Failure

Medtronic, Inc. announced FDA approval and U.S. launch on 6 May 2013 of its newest cardiac devices: the Viva portfolio of cardiac resynchronization therapy with defibrillation (CRT-D) devices, and the Evera portfolio of implantable cardioverter-defibrillators (ICD).

The Viva CRT-D significantly improves response rate to the therapy for many indicated Heart Failure patients, with a demonstrated 21 percent reduction in overall ...

Four year follow up on EVEREST II study of Mitra Clip (Abbott)

Four-year follow-up of the Endovascular Valve Edge-to-Edge Repair Study II (EVEREST II) show no differences in the primary end point between the Mitra Clip (Abbott) procedure and surgery and significantly more follow-up surgeries for residual mitral regurgitation (MR) in the clip group.At four years, surgery for mitral-valve dysfunction was needed for one out of every four patients treated with the ...

Immunoglobulin (Baxter) fails Phase III study for treatment of Alzheimers disease

Baxter International Inc. has announced that its Phase III clinical study of immunoglobulin (IG) did not meet its co-primary endpoints of reducing cognitive decline and preserving functional abilities in patients with mild to moderate Alzheimer's disease. The Gammaglobulin Alzheimer's Partnership (GAP) study was conducted by Baxter in collaboration with the Alzheimer's Disease Cooperative Study (ADCS), a clinical trial consortium ...

Metreleptin sub analysis in paediatric patients with Lipodystrophy

BMS and AstraZeneca announce the results from a 12-month sub-group analysis of a National Institutes of Health (NIH), open-label, long-term research study of metreleptin, an investigational agent for the treatment of metabolic disorders associated with inherited or acquired Lipodystrophy (LD), a rare disease estimated to affect a few thousand people around the world, often with an early age of ...

PALACE 4 study confirms success of apremilast (Celgene) in treatment of Psoriaric Arthritis

Celgene International Sàrl,has announced that statistical significance was achieved for the primary endpoint of ACR 20 at week 16 for patients receiving apremilast 20 mg and 30 mg BID monotherapy in PALACE 4 study. PALACE 4 is the fourth randomized, placebo-controlled study evaluating the Company’s novel, oral small-molecule inhibitor of phosphodiesterase 4 (PDE4) in patients with Psoriatic Arthritis. This is ...

FDA approves Liptruzet (Merck Inc) for Dyslipidaemia

The FDA has approved Liptruzet (ezetimibe and atorvastatin) tablets, from Merck Inc, for the treatment of Dyslipidaemia. It is indicated for elevated low-density lipoprotein (LDL) cholesterol in patients with primary or mixed hyperlipidemia as adjunctive therapy to diet when diet alone is not enough. Approval is based on results including a multicenter, clinical study in which 628 patients with hyperlipidemia ...

Phase III trial shows FloraGlo lutein (OmniActive Health Technologies) fails to protect against AMD

A multicenter, randomized clinical trial that included people at high risk for progression to advanced Age-related Macular Degeneration (AMD), shows that adding lutein and zeaxanthin, and the omega-3 fatty acids DHA and EPA, as found in FloraGlo lutein from OmniActive Health Technologies, to a formulation of antioxidant vitamins and minerals (so-called AREDS formulation) that has shown effectiveness in reducing risk, ...

Early prediction of Epileptic seizures study from NeuroVista

The Seizure Advisory System from NeuroVista is an implantable device that has successfully and correctly predicted epilepsy seizures in some adults for whom drugs have not worked. A proof of concept study, performed by researchers at the University of Melbourne in Australia, involved 15 patients with an implant of electrodes between the skull and surface of the brain that ...

FDA Advisory Committee rejects Melblez Kit (Delcath) for Ocular melanioma metastatic to the Liver

Delcath Systems, Inc. announced that the FDA Oncologic Drugs Advisory Committee (ODAC) voted 16 to 0 with no abstentions that benefits of treatment with Delcath's Melblez Kit (Melblez (melphalan) for Injection for use with the Delcath Hepatic Delivery System) for the treatment of patients with unresectable Ocular melanoma metastatic to the Liver do not outweigh the risks associated with ...

Phase IIb study with STX 209 (Seaside Therapeutics) reports on efficacy in Autism Spectrum Disorder

Study 209AS208 is a randomized, double-blind, placebo-controlled Phase IIb study which , evaluated the safety, tolerability, and efficacy of STX 209 ( arbaclofen) from Seaside Therapeutics, in 150 subjects (age 5 to 21 years) with Autism Spectrum Disorder (ASD), with a particular focus on the core impairments of social function.

Patients were randomized to receive either arbaclofen or placebo ...

Phase III study of Sufentanil NanoTab PCA System (AcelRx Pharmaceuticals) shows superiority to morphine for Pain relief

Clinical results from a Phase III trial of Sufentanil NanoTab PCA System, from AcelRx Pharmaceuticals, for the treatment of moderate-to-severe Acute Pain in the hospital setting demonstrate that sufentanil delivered via the NanoTab System has a significantly greater pain intensity reduction in the first four hours after treatment than IV PCA morphine (p<0.01).

In addition, there were fewer patients throughout ...

FDA approves Vyvanse (Shire) as maintenance treatment of ADHD for children and adolescents

The FDA has on 1 May 2013, approved the prescription medication Vyvanse (lisdexamfetamine dimesylate) Capsules, (CII) from Shire ,as a maintenance treatment in children and adolescents with Attention-Deficit/Hyperactivity Disorder (ADHD). Vyvanse is currently approved as a maintenance treatment in adults with ADHD. With this new approval, Vyvanse becomes the only stimulant approved for maintenance treatment in children, adolescents, and ...

CHMP recommends Revlimid for treatment of Myelodysplastic Syndromes

The Committee for Medicinal Products for Human Use (CHMP) has recommended Revlimid (lenalidomide)from Celgene for the treatment of patients with transfusion-dependent anaemia due to low- or intermediate-1-risk Myelodysplastic Syndromes associated with an isolated deletion 5q cytogenetic abnormality when other therapeutic options are insufficient or inadequate.

FDA approves Procysbi (Raptor Pharmaceutical) for Nephropathic Cystinosis

The FDA has approved Procysbi (cysteamine bitartrate) delayed release capsules, from Raptor Pharmaceutical, for the treatment of Nephropathic Cystinosis in adults and children 6 years and older. The approval was based on a New Drug Application (NDA) comprising data from six clinical trials, including a multi-center randomized, active-controlled Phase III trial of 43 patients with Nephropathic Cystinosis and extension data ...

CHMP recommends Erivedge (Roche) for treatment of Basal Cell Carcinoma

Roche has announced that the European Union’s Committee for Medicinal Products for Human Use (CHMP) has recommended conditional approval of Erivedge (vismodegib) for the treatment of adult patients with symptomatic metastatic Basal Cell Carcinoma, or locally advanced Basal Cell Carcinoma inappropriate for surgery or radiotherapy. Conditional approval would make Erivedge the first licensed treatment for patients in Europe with ...

FDA approves Kcentra (CSL Behring)to reverse vitamin K antagonist anticoagulation with major bleeding

The FDA on 29 April 2013 has approved Kcentra (Prothrombin Complex Concentrate, Human) for the urgent reversal of vitamin K antagonist (VKA) anticoagulation in adults with acute major bleeding. Plasma is the only other product approved for this use in the United States. Patients receiving chronic anticoagulation therapy with warfarin and other VKA anticoagulants to prevent blood clotting in conditions ...

FDA issues Complete Response Letters for elvitegravir and cobicistat (Gilead Sciences)

Gilead Sciences, Inc. has announced that the company has received Complete Response Letters from the FDA for its New Drug Applications (NDAs) for elvitegravir and cobicistat for use as part of HIV treatment regimens.

In its communications,the FDA states that it cannot approve the applications in their current forms. The letters state that during recent inspections, deficiencies in ...

Phase II study of ORMD 0801 (Oramed Pharmaceuticals) successful for Type 1 Diabetes treatment

Oramed Pharmaceutical's clinical studies assessing the safety and efficacy of ORMD 0801 (oral insulin) in patients with Type 1 Diabetes (T1DM) show that the drug was safe and well tolerated. A study in a subpopulation of T1DM patients who experience frequent and unpredictable swings in their blood sugar levels, shows that the drug effectively kept blood sugar levels in check, ...

CHMP recommends Spedra (avanafil) as a treatment for Erectile Dysfunction in adult men

Vivus, the USA-based pharmaceutical company has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP), recommending European Commission approval for Spedra (Avanafil) for the treatment of erectile dysfunction in adult men.

Avanafil is a selective phosphodiesterase type 5 inhibitor which increased the percentage of sexual attempts resulting in successful intercourse by roughly 20%-30% over placebo ...

Merck Inc and Pfizer to collaborate on ertugliflozin for Type 2 Diabetes

Merck & Co., Inc.and Pfizer Inc. have announced that they have entered into a worldwide (except Japan) collaboration agreement for the development and commercialization of Pfizer’s ertugliflozin (PF-04971729), an investigational oral sodium glucose cotransporter (SGLT2) inhibitor being evaluated for the treatment of Type 2 Diabetes. Under the terms of the agreement, Merck, through a subsidiary, and Pfizer will collaborate ...

BioMarin files Vimzim at EMA for Mucopolysaccharidosis Type IVA

BioMarin Pharmaceutical Inc. has announced the submission of a Marketing Authorization Application (MAA) to the European Medicines Agency for Vimizim (BMN-110, elosulfase alfa), an enzyme replacement therapy under evaluation for the treatment of patients with the rare lysosomal storage disorder Mucopolysaccharidosis Type IVA (MPS IVA), also called Morquio A Syndrome. A Biologics License Application for Vimizim was submitted to ...

CHMP recommends approval of Nuedexta (Avanir Pharma) for Pseudo Bulbar Affect

The EMA's CHMP has adopted a positive opinion for Nuedexta (dextromethorphan hydrobromide and quinidine sulphate), from Avanir Pharma, recommending it be approved for the treatment of Pseudo Bulbar Affect (PBA), irrespective of neurologic cause. In addition, the CHMP also recommended approval of two dose strengths; 20/10 mg and 30/10 mg capsules.

The drug has been tested in the Phase III ...

Phase II data show CEM 101 (Cempra Inc) useful against urogenital Infections and multidrug-resistant pathogens

New Phase II data on CEM 101 (solithromycin), from Cempra Inc, in patients with Infectious Diseases show that patients with gonococcal infections were treated successfully in 100% of cases. Infections were eradicated from all 22 evaluable patients (from an enrollment of 28) including from cervical, urethral, rectal and pharyngeal infection sites. It was well tolerated and was accompanied by only ...

CHMP recommends Xtandi (enzalutamide) as a treatment for Prostate Cancer

Astellas Pharma Europe Ltd., the European Headquarters of Astellas Pharma Inc. and Medivation, Inc.have received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP), recommending European Commission approval for Xtandi (enzalutamide) capsules for the treatment of adult men with metastatic castration-resistant Prostate Cancer whose disease has progressed on or after docetaxel therapy.

Enzalutamide is ...

CHMP rejects Xeljanz (Pfizer) as a treatment for Rheumatoid Arthritis

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a negative opinion for Xeljanz (tofacitinib citrate) for the treatment of adult patients with moderate-to-severe active Rheumatoid Arthritis. The CHMP is of the opinion that Xeljanz does not demonstrate a favorable risk:benefit profile at this time and recommended against marketing authorization.

...

NICE confirms rejection of Jakavi(Novartis) for Myelofibrosis

NICE has confirmed that it will not recommend Jakavi(ruxolitinib) from Novartis after it found problems with its data and the costing model. NICE has published final draft guidance not recommending Jakavi for the treatment of disease-related splenomegaly (enlarged spleen) or its symptoms in adults with primary Myelofibrosis, or post polycythaemia vera Myelofibrosis or post essential thrombocythaemia Myelofibrosis.

Novartis ...

Positive trial results for OMS 302 (Omeros Corporation) in Cataract surgery

Analyses of Phase II and Phase II clinical data show the favorable impact of OMS 302 (ketorolac and phenylephrine), from Omeros Corporation, on reducing the incidence of miosis (pupil constriction) during intraocular lens replacement (ILR) surgery for Cataracts. In patients receiving standard-of-care preoperative mydriatic topical drops, OMS 302 reduces the occurrence of pupil constriction of 2.5 mm or more and ...

FDA gives 510(k) approval for the HydraSolve autologous fat transfer system (Andrew Technologies) for Lipoplasty

Andrew Technologies has received 510(k) clearance from the FDA for its HydraSolve Lipoplasty system for autologous fat transfer, in which adipose tissue is harvested and can be reinjected into the same patient for rejuvenation or augmentation. HydraSolve achieves liquefaction of fat tissue by cell disaggregation, not by emulsification and the lysing of cell membranes. The system rapidly removes fat and ...

Phase II trial of ARX 04 Sufentanil NanoTabs (AcelRx Pharmaceuticals) meets endpoint for Acute Pain

Top-line results from a placebo-controlled, dose-finding, Phase II study of sublingual sufentanil NanoTab for Acute Pain, ARX 04, from AcelRx Pharmaceuticals, show that the treatment successfully met its primary endpoint. The study randomized 101 patients following bunionectomy surgery in a 2:2:1 ratio to 30 mcg sufentanil, 20 mcg sufentanil or placebo treatment arms. Results demonstrated that patients receiving 30 mcg ...

Phase II data shows ABT 450/r, ABT 267, ABT 333 (Abbvie) successful in patients with Hepatitis C

New data from AbbVie's Phase IIb Aviator trial of ABT 450/r (protease inhibitor and ritonavir), ABT 267 (NS5A inhibitor) and ABT 333 (non-nucleoside polymerase inhibitor) for the treatment of Hepatitis C virus (HCV) infection demonstrates sustained viral response rates across multiple patient types with HCV Genotype 1. Data shows that 96 percent of treatment-naive patients and 93 percent of prior ...

Phase III trial of BI 201335 (Boehringer) succesful for Hepatitis C patients

Results from the pivotal Phase III STARTVerso1 trial of BI 201335 (faldaprevir), from Boehringer, in combination with pegylated interferon and ribavirin (PegIFN/RBV) show that untreated patients with genotype-1 Hepatitis C virus (HCV) who received once-daily faldaprevir plus PegIFN/RBV, 79% and 80% in the 120mg and 240mg arms, respectively, achieved viral cure 12 weeks after treatment was completed (SVR12). This is ...

Picato(Leo Pharma) fails IQWiG assessment for Actinic Keratosis in Germany

In a preliminary assessment, the German Institute for Quality and Efficiency in Health Care ( IQWiG) has concluded that Leo Pharma's Picato gel (ingenol mebutate) for Actinic Keratosis, does not provide any added benefit over diclofenac/hyaluronic.

IQWiG commented that the drug manufacturer did not submit any relevant data: it did not cite any studies that directly compared ingenol ...

FDA approves Amitiza(Sucampo/Takeda) for Opioid-induced Constipation

Sucampo Pharmaceuticals, Inc. and Takeda Pharmaceuticals U.S.A., Inc. have announced that the FDA has approved Sucampo’s supplemental new drug application for Amitiza(lubiprostone) (24 mcg twice daily) as the first and only oral medication for the treatment of Opioid-induced Constipation (OIC) in adult patients with chronic, non-cancer pain. The effectiveness of Amitiza in the treatment of Opioid-induced Constipation in patients ...

European Commission approves Hexyon/Hexcima (Sanofi Pasteur) Six in One vaccine

Sanofi Pasteur, the vaccines division of Sanofi has announced that the European Commission, on 22 April 2013, approved Sanofi Pasteur’s 6-in-1 pediatric vaccine Hexyon/Hexacima (DTaP-IPV-Hib-HepB vaccine) for primary and booster vaccination of infants from six weeks of age. Hexyon/Hexacima is the only fully liquid, ready-to-use, 6-in-1 vaccine to protect infants against diphtheria, tetanus, pertussis (whooping cough), Hepatitis B, poliomyelitis ...

FDA approves M2 Compact MRI (Aspect Imaging) for wrist Imaging

The FDA has cleared the M2 Compact MRI system, from Aspect Imaging, for diagnostic Imaging of the wrist. Unlike conventional high field MRI systems, the M2 Compact Wrist System does not require a shielded room, cryogens, or high capacity electrical power. The system features an innovative 1 Tesla, self-shielded, permanent magnet operating in a quiet manner. As a result, the ...

FDA approves Simbrinza (Alcon/Novartis) for Glaucoma and Ocular Hypertension treatment

The FDA has given approval for Simbrinza Suspension, from Alcon/Novartis, indicated for the reduction of elevated intraocular pressure (IOP) in patients with primary open-angle Glaucoma or Ocular Hypertension.Elevated IOP is the only modifiable risk factor for Glaucoma. Glaucoma is a group of eye diseases that lead to progressive damage of the optic nerve and can result in gradual, irreversible ...

Phase II study of CERE 120 (Ceregene) for Parkinsons fails to reach primary endpoint

Top-line data from a double-blind, randomized, controlled Phase IIb clinical study of CERE 120 (AAV-neurturin), from Ceregene, for Parkinson's disease failed to demonstrate statistically significant efficacy on its primary endpoint. Fifty-one patients with moderately advanced Parkinson's disease which could not be controlled with conventional medication were enrolled. Approximately half received CERE 120 while the other half received sham (placebo) surgery. ...

Synera (Nuvo Research) significantly improves Pain in Shoulder Impingement Syndrome

New data on Synera (lidocaine and tetracaine) topical patch, from Nuvo Research, showed that Synera provided clinically significant improvement of Pain and function in Shoulder Impingement Syndrome (SIS). The data was a pooled analysis of two open label pilot studies of Synera. 70% of patients experienced a clinically meaningful reduction (more than a 30% reduction) in average pain scores. In ...

ISMP analysis highlights link between pancreatic cancer and pancreatitis and GLP-1 class of anti diabetic medications

The Institute for Medication Practices (ISMP) has undertaken an analysis that finds reports of pancreatic cancer and pancreatitis for GLP-1 anti-mimetic drugs, Byetta (BMS/AstraZeneca), Januvia (Merck Inc.), Victoza (Novo Nordisk) that are 25 times higher compared to older treatments, metformin and the sulfonulyreas.

The changes were lower but greater than the older treatments with Tradjenta (Boehringer/Eli Lilly) and ...

Ruconest (Santarus/Pharming) is re-filed with FDA for treatment of Hereditary Angioedema

Santarus, Inc. and Pharming Group NV have announced the submission of a Biologics License Application (BLA) to the FDA to obtain marketing approval for Ruconest (recombinant human C1 esterase inhibitor) 50 U/kg, an investigational drug for the treatment of acute angioedema attacks in patients with Hereditary Angioedema (HAE). The safety and efficacy of Ruconest for the treatment of HAE attacks ...

EU extends Berinert (CSL Behring) indication for pre-procedure prevention of acute HAE episodes

The EU has approved an extended use of Berinert (C1 inhibitor concentrate), from CSL Behring, for pre-procedure prevention (short-term prophylaxis) of acute episodes of Hereditary Angio-Oedema (HAE) in adult and pediatric patients undergoing medical, dental or surgical procedures. Berinert is already indicated in Europe for the treatment of acute attacks of HAE at all body sites in adults and children. ...

FDA approves FibroScan Elastography Imaging system(Echosens) for non-invasive liver disease diagnosis

The FibroScan device from Echosens has received 510(k) clearance from the FDA for use in non-invasive liver disease diagnosis. Based on a technology called Transient Elastography, FibroScan assesses liver shear wave speed and equivalent stiffness in a rapid, simple, non-invasive and totally painless way. Initially introduced in the European market in 2003, it has received market clearances in China, Canada, ...

FDA approves new product labelling for OxyContin Controlled Release(Purdue Pharma) for Pain Management

Purdue Pharma L.P. has announced that the FDA has approved new language for the product label for OxyContin (oxycodone hydrochloride controlled-release) Tablets CII that describes abuse-deterrence studies conducted with the reformulated tablets. The new labeling indicates that the product has physical and chemical properties that are expected to make abuse via injection difficult and to reduce abuse via the intranasal ...

Phase III trial shows benefits of Resolute ZES (Medtronic) in CAD patients with Diabetes

New data shows that treatment with the Resolute (zotarolimus-eluting stent), from Medtronic, led to positive outcomes for CAD patients with Diabetes who were not taking insulin and for CAD patients without Diabetes. It presents the results of two analyses from the Phase III RESOLUTE program, which enrolled a total of 5,130 patients. This set a 12-month target vessel failure (TVF) ...

REMEDEE study of COMBO Dual Therapy Stent (Orbus Neich) meets primary endpoint

Data from the REMEDEE study of the COMBO Dual Therapy Stent, from Orbus Neich, demonstrated that the stent met the study's primary endpoint in CAD patients and was found to be effective in controlling neointimal proliferation. Specifically, the COMBO Stent was shown to be non-inferior to a drug eluting stent (DES) with respect to angiographic in-stent late lumen loss at ...

EMA Pharmacovigilance Risk Assessment Committee recommends restrictions on Protelos (Servier) as a treatment for Osteoporosis

The EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) recommended restrictions in the use of Protelos/Osseor (strontium ranelate) from Servier, following the evaluation of data showing an increased risk of heart problems, including heart attacks. It will adopt a final opinion at the next CHMP meeting of 22 to 25 April 2013.

Phase II study of Favorite (Activaero) shows superiority over conventional Asthma treatment

Results from a Phase II trial in children with mild to moderate Asthma, conducted with the Favorite Inhalation system (budesonide suspension), from Activaero, shows it is effective and holds the promise to become the preferred treatment option when compared to conventional, general purpose therapy. Activaero's Favorite (Flow and Volume Controlled Inhalation Technology) is a drug-device combination consisting of budesonide in ...

Air Band (Maquet Cardiovascular) given FDA 510(k) and EU CE Mark approval for use in Surgery

The FDA has given 510(k) clearance for the Air Band radial compression device, from Maquet Cardiovascular. The device is indicated to assist hemostasis of the radial artery after a transradial procedure, and is designed to compress the radial artery puncture site while maintaining site visibility and a secure fit around the wrist during Surgery. Additionally, the EU has given CE ...

FDA approves Precision Spectra Spinal Cord Stimulator System (Boston Scientific) for treating Chronic Pain

The FDA has approved the Precision Spectra Spinal Cord Stimulator (SCS) System, from Boston Scientific, for treating Chronic Pain. The Precision Spectra System is the world's first and only SCS system with Illumina 3D software and 32 contacts, and is designed to provide improved pain relief to a wide range of patients who suffer from chronic pain. By providing 32 ...

FDA approves Versa HD Radiation Therapy System (Elekta)

Elekta has received 510(k) clearance from the FDA for the Versa HD radiation therapy system for cancer treatment. Versa HD is an advanced linear accelerator system designed to improve patient care and treat a broader spectrum of cancers. The system is fully integrated with the Agility 160-leaf multileaf collimator (MLC), giving the Versa HD high-definition, high-speed beam shaping over a ...

Nice recommends Lucentis (Novartis) for Macular Oedema following RVO

NICE has issued final draft guidance recommending Lucentis (ranibizumab), from Novartis, as a treatment for sight problems caused by Macular Oedema following central retinal vein occlusion (CRVO), provided Novartis makes the drug available under an agreed patient access scheme (PAS). It also recommends it as a treatment option following branch retinal vein occlusion (BRVO) when standard treatment with laser photocoagulation ...

NICE rejects Pixuvri (Cell Therapeutics) for the treatment of Non-Hodgkin's Lymphoma

NICE has issued draft guidance not recommending the use of Pixuvri (pixantrone), from Cell Therapeutics, for an aggressive form of Non-Hodgkin's Lymphoma. The committee concluded there was insufficient evidence to show that the drug is more effective than current treatments and also found that it does not represent good value for money. According to NICE, the clinical trial evidence submitted ...

Phase II study of CQR 1 (Cardio3Biosciences) published in Journal of the American College of Cardiology

Results from a Phase II prospective, multicenter, randomized study to evaluate the feasibility, safety, and efficacy of CQR 1 (formerly C-CURE), from Cardio3Biosciences in the treatment of patients with chronic Heart Failure secondary to ischemic cardiomyopathy have been published in the Journal of the American College of Cardiology. The paper shows a statistically significant improvement in cardiac function for the ...

Study shows Ostinol (ZyCal Bioceuticals) improves pain and stiffness in Osteoarthritis

Results of the first double-blind, placebo-controlled study evaluating the benefits of Ostinol (cyplexinol), from ZyCal Bioceuticals, in alleviating symptoms of Osteoarthritis shows that this nutritional supplement decreases pain and stiffness, and offers an increase in quality of life as compared to placebo. Cyplexinol is a biologically active protein complex consisting of bone morphogenetic proteins which stimulate bone and cartilage growth ...

EU approves Brio/Libra/LibraXP deep brain stimulation systems (St Jude Medical) for Dystonia

The EU has given CE Mark approval of the Brio, Libra and LibraXP deep brain stimulation (DBS) systems, from St Jude Medical, for managing the symptoms of intractable primary and secondary Dystonia, a neurological movement disorder that causes involuntarily spasm. This approval represents the first by a regulatory agency for the use of deep brain stimulation to manage both primary ...

FDA recommends Trulign Toric (Bausch & Lomb) for Cataract surgery

The FDA's Ophthalmic Devices Panel voted 10-1 to recommend the approval of Bausch & Lomb Opthalmic's Trulign Toric intraocular lens to repair vision after Cataract surgery. The Trulign Toric intraocular lens is a multi-piece implant inserted into the capsular bag of the eye to correct problems stemming from cataract removal, restoring vision without spectacles.

The filing is based on a ...

FDA approves Diclegis (Duchesnay USA) for treatment of Nausea in pregnancy

The FDA has approved Diclegis (doxylamine succinate/pyridoxine hydrochloride) delayed-release tablets, from Duchesnay USA, for the treatment of Nausea and vomiting of pregnancy (NVP) in women who do not respond to conservative management. The NDA submission was based on a 15-day double-blind, randomized, multi-center placebo-controlled trial studying pregnant women 18 years of age or older, 7 to 14 weeks gestation, with ...

FDA approves Prolensa (Ista/Bausch & Lomb) for postoperative Ocular Inflammation

The FDA has approved Prolensa (bromfenac ophthalmic solution) 0.07 percent prescription eye drop, from Ista/Bausch & Lomb, for the treatment of postoperative Ocular Inflammation and reduction of Ocular pain in patients who have undergone cataract surgery. The efficacy of Prolensa was evaluated in two randomized, double-masked, vehicle-controlled studies of patients undergoing cataract surgery. Twice as many patients as vehicle (46 ...

Phase II data shows PCI 32765 (Pharmacyclics Inc.) provides sustained control in CLL patients

Results from a Phase II trial of PCI 32765 (ibrutinib), from Pharmacyclics Inc., demonstrates the drug offers rapid and sustained control as a monotherapy in untreated, relapsed and refractory Chronic Lymphocytic Leukemia (CLL) patients, irrespective of characteristics that predict poor outcomes to chemoimmunotherapy. It included an analysis of two CLL patient cohorts: the elderly, above 65 years of age, (n=24) ...

OverStitch Endoscopic Suturing System gets CE Mark

Apollo Endosurgery, Inc., a company focused on the development of devices that enable a new generation of endoscopic surgical procedures, announced that its OverStitch Endoscopic Suturing System has received the European Union's CE Mark. The company plans to immediately launch the system to select centers in several European countries.

The company is working with distributors in several European countries ...

Roche Diagnostics launches Elecsys Calcitonin Thyroid Cancer test

Roche Diagnostics has announced the global launch (except US) of Elecsys Calcitonin, a new laboratory test for the diagnosis and lifelong monitoring of medullary thyroid cancer patients after thyroid surgery. Calcitonin is a specific tumour marker that can help healthcare professionals diagnose medullary thyroid carcinoma early, as elevated concentrations of calcitonin in the blood are associated with the onset ...

US Court removes age limits on Plan B One Step contraceptive

A U.S. District Judge Edward Korman in Brooklyn, NY, ruled the refusal by the FDA to remove age limits for the Plan B One Step morning after contraceptive pill had been "arbitrary, capricious and unreasonable,". He ordered that the "morning after" birth control pill be made freely available to girls of all ages without a prescription.

Fostamatinib (AstraZeneca) mixed results in OSKIRA-1 trial for RA

AstraZeneca has announced top-line results of OSKIRA-1, a Phase III study to assess the efficacy and safety of fostamatinib, the first oral spleen tyrosine kinase (SYK) inhibitor in development for Rheumatoid Arthritis (RA).

OSKIRA-1 had two primary endpoints: assessing signs and symptoms of RA as measured by ACR20 response rates, and an X-ray endpoint known as mTSS (modified ...

Lymphoseek (Navidea) success in Head and Neck cancer trial

Navidea Biopharmaceuticals, Inc. announced top-line results from the interim analysis of its Phase III clinical trial, NEO3-06, of Lymphoseek (technetium 99m tilmanocept) Injection in patients with head and neck squamous cell carcinoma. Results of the pre-planned interim analysis demonstrated that Lymphoseek met the primary efficacy endpoint of accurately identifying sentinel lymph nodes (SLNs) in subjects with squamous cell carcinoma ...

Byetta and Bydureon to be marketed for Type 2 Diabetes by BMS and Astra Zeneca in the UK

BMS and AstraZeneca have agreed with Eli Lilly to undertake the marketing of exenatide in the forms of Byetta and weekly injectable Bydureon in the United Kingdom which will add these drugs to their Type 2 Diabetes alliance....

FDA approves Karbinal ER (Tris Pharma) for Allergic Rhinitis

The FDA has on 3 April 2013 approved a New Drug Application (NDA) for Karbinal ER (carbinoxamine maleate) Extended-release Oral Suspension 4mg/5ml, from Tris Pharma, being the first sustained-release histamine receptor blocking agent indicated for the treatment of seasonal and perennial Allergic Rhinitis in children ages 2 and up.

Prior to 2006, carbinoxamine was widely used, with dozens of carbinoxamine-containing ...

Phase III success for Cymbalta (Eli Lilly) for Peripheral Neuropathy

Daily Cymbalta( duloxetine) therapy from Eli Lilly, was effective and well-tolerated for the treatment of painful Chemotherapy-induced Peripheral Neuropathy (CIPN), according to a randomized, double-blind, placebo-controlled Phase III trial presented at the 2012 American Society of Clinical Oncology Annual Meeting.

Patients were randomized to receive duloxetine followed by placebo (n=115) or placebo followed by duloxetine (n=116); initial crossover periods for ...

SELECT study of daclizumab High Yield (Biogen) for MS published in The Lancet

Biogen Idec has announced that results from the daclizumab high-yield process (DAC HYP) SELECT clinical trial have been published as an online article in The Lancet. SELECT was a Phase IIb study designed to determine the efficacy and safety of DAC HYP in patients with relapsing-remitting multiple sclerosis.

Published results demonstrate that both 150 mg and 300 mg subcutaneous ...

UK and German approvals for FLUARIX TETRA (GSK) influenza vaccine

GSK announced the marketing authorisation of its quadrivalent (four-strain) influenza vaccine in Germany and the UK. Following a decentralised procedure, Germany’s Paul Ehrlich Institut (PEI) was the first national regulatory authority in Europe to grant marketing authorisation for this influenza vaccine, followed by the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK. This is the first four-strain ...

IQWiG report on Eliquis (BMS/Pfizer) for Stroke Prevention associated with Atrial Fibrillation

The Institute for Quality and Efficiency in Healthcare (IQWiG)in Germany said that Eliquis (apixaban) from BMS and partner Pfizer Inc.has "significant" additional benefit to prevent Stroke and Systemic Embolism in adults with non-valvular atrial fibrillation (AF) with one or more risk factors -- an indication approved by the European Commission in November.

IQWiG said Eliquis provides "significant" additional ...

Revance Therapeutics to initiate Phase III trial for RT 001 for treatment of Facial Wrinkles

Revance Therapeutics inc has secured the funding necessary to initiate a Phase III trial for Botulinum Toxin Type A Topical Gel for the treatment of facial wrinkles (crows feet) that is intended to compete with injected therapies such as Botox.

RT 001 is also currently in Phase II trials for the topical treatment of hyperhidrosis (excessive sweating), and chronic migraine ...

Elacyt (Clavis Pharma) fails Phase III trial for AML

Clavis Pharma announced results of the Phase III CLAVELA study investigating Elacyt (elacytarabine) in patients with relapsed or refractory Acute Myeloid Leukaemia (AML). The trial showed that there was no significant difference in overall survival between the two arms where patients were randomised to receive either elacytarabine or investigator's choice of treatment. Median survival in the elacytarabine arm was ...

FDA approves Quartette (Teva) for Contraception.

Teva Pharmaceutical Industries Ltd. announced that the FDA has on 28 March 2013, approved Quartette, (levonorgestrel/ethinyl estradiol and ethinyl estradiol) tablets for prevention of pregnancy.

The Phase III clinical trial, which involved more than 3,000 women, found that Quartette was 97 percent effective at preventing pregnancy. According to Teva, Quartette represents the next generation of extended regimen oral ...

FDA approves Invokana (Janssen) to treat Type 2 Diabetes

The FDA has on 29 March 2013 approved Invokana (canagliflozin) tablets from Janssen Pharmaceuticals, used with diet and exercise, to improve glycemic control in adults with Type 2 Diabetes. Its safety and effectiveness were evaluated in nine clinical trials involving over 10,285 patients with Type 2 Diabetes. The trials showed improvement in hemoglobin A1c levels (a measure of blood ...

FDA issues Complete Response Letter to AP Pharma relating to AP F 530 for CINV

AP PHarma as announced that it has received a Complete Response Letter (CRL) from the FDA regarding its New Drug Application for its lead product candidate, APF 530, for the prevention of Chemotherapy-induced Nausea and Vomiting (CINV). The FDA has requested the refinement of a product quality analytical test method, and that certain deficiencies identified during facility pre-approval inspections ...

Janssen R&D files TMC 435 to the FDA for Hepatitis C

Janssen R&D has submitted a New Drug Application (NDA) to the FDA seeking approval for TMC 435 (simeprevir) 150mg capsule with pegylated interferon and ribavirin for the treatment of genotype 1 chronic Hepatitis C in adult patients. The submission is supported in part by data from three pivotal Phase III studies: QUEST-1 and QUEST-2 in treatment-naïve patients and PROMISE in ...

Miravirsen (Santaris Pharma) Phase II trial for Hepatitis C is reported in NEJM

Santaris Pharma A/S, has announced the publication of study results online in the New England Journal of Medicine (NEJM). The publication highlights the potential benefits of miravirsen, a host-targeted, pan-HCV genotype anti-viral agent and the first microRNA-targeted drug to enter clinical trials for the treatment of Hepatitis C virus (HCV). In the study, miravirsen, given as a four-week monotherapy ...

Phase II data shows CNV 1014802 (Convergence Pharmaceuticals) provides benefits for patients with Trigeminal Neuralgia

Interim data from the Phase II trial of CNV 1014802, from Convergence Pharmaceuticals, in patients with Trigeminal Neuralgia shows that the drug has a positive pharmacokinetic and safety profile for this pain condition. Eligible patients were entered into a 3-week open-label treatment period with CNV 1014802 at a dose of 150mg three times a day. If a successful response was ...

Phase III success for Androxal (Repros Therapeutics) for Hypogonadism

Repros Therapeutics Inc. reported top-line results for the first pivotal study of Androxal, ZA-301, in the treatment of secondary Hypogonadism. Results for the Intent-to-Treat population met both co-primary endpoints mandated by the FDA. The Intent-to-Treat population included all men randomized in the study whether or not they completed the study. 151 subjects were randomized into the study, 38 on ...

European Commission grants conditional marketing approval to Bosulif (Pfizer) for PH+CML

The European Commission (EC) has granted conditional marketing authorization for Bosulif (bosutinib) from Pfizer, in the European Union for the treatment of adult patients with chronic phase (CP), accelerated phase (AP) and blast phase (BP) Philadelphia chromosome positive Chronic Myelogenous Leukemia (Ph+ CML) previously treated with one or more tyrosine kinase inhibitor(s) and for whom imatinib, nilotinib and dasatinib ...

FDA approves Tecfidera (Biogen IDEC) to treat relapsing Multiple Sclerosis

Biogen Idec has announced that the FDA has on 27 March 2013, approved Tecfidera (dimethyl fumarate), a new first-line oral treatment for people with relapsing forms of Multiple Sclerosis .

The FDA approval of Tecfidera is based on data from a robust clinical development program that included DEFINE and CONFIRM, two global Phase III studies that enrolled more than 2,600 ...

Merck Inc. files Timothy grass pollen (Phleum pratense) allergy immunotherapy tablet at FDA

Merck Inc., announced that the Biologics License Application (BLA) for its investigational Timothy grass pollen (Phleum pratense) allergy immunotherapy tablet (AIT) has been accepted for review by the FDA. In March, the company also submitted a BLA to the FDA for its investigational ragweed pollen (Ambrosia artemisiifolia) AIT.

The BLA for Merck’s grass pollen AIT is supported by ...

Lundbeck and Otsuka collaborate on Lu AE 58054 as a treatment for Alzheimers disease

Lundbeck A/S and Otsuka Pharmaceutical company have announced a license and development agreement for Lu AE 58054, for the treatment of Alzheimer's disease. Under the terms of the agreement, Lundbeck will grant Otsuka co-development and co-commercialization rights to Lu AE58054 in the U.S., Canada, East Asia including Japan, major European countries and Nordic countries.

The pivotal clinical program with ...

NICE rejects Xalkori (Pfizer) for treatment of Non Small Cell Lung Cancer

The National Institute for Health and Clinical Excellence (NICE) has issued new draft guidance in which it does not recommend Xalkori (crizotinib),the tyrosine kinase inhibitor from Pfizer. for use in previously treated anaplastic-lymphoma-kinase-(ALK) positive advanced Non-Small-Cell Lung Cancer (NSCLC), but has opened a public consultation on this preliminary decision. NICE did not view the drug as being cost effective. ...

Boehringer and Eli Lilly submit NDA to the FDA for empagliflozin for treatment of Type 2 Diabetes

Boehringer Ingelheim and Eli Lilly and Company have announced that a New Drug Application (NDA) for the investigational sodium glucose co-transporter-2 (SGLT2) inhibitor empagliflozin was recently submitted to the FDA for the treatment of Type 2 Diabetes Mellitus (T2D) in adults.

Empagliflozin is a member of the SGLT2 inhibitor class of drugs being investigated for the reduction of ...

Complete Response Letter from FDA for Q-Pan H5N1 influenza vaccine

GSK has received a Complete Response Letter from the FDA for its pandemic influenza A vaccine, called Q-Pan H5N1. Q-PAN H5N1 is intended for the prevention of Infuenza in adults who are at increased risk of exposure to the H5N1 influenza virus subtype contained in the vaccine.

In November 2012, the FDA’s Vaccines and Related Biological Products Advisory Committee ...

Gilenya (Novartis) decreases brain volume loss in Multiple Sclerosis patients

Gilenya (fingolimod), from Novartis, is the only approved treatment shown to consistently decrease brain volume loss in Multiple Sclerosis patients. Brain volume loss is the best magnetic resonance imaging correlate of long-term disability.

New data presented at the recent 65th Annual Meeting American Academy of Neurology 2013, showed that Gilenya reduced the rate of brain volume loss by ...

Phase II study of Xiaflex (Auxilium Pharma) shows benefits for patients with Adhesive Capsulitis

Auxilium Pharmaceuticals has announced positive data for Xiaflex (clostridial collagenase injection), from Auxilium Pharma, for the treatment of adults with Adhesive Capsulitis (AC), or Frozen Shoulder Syndrome. The Phase IIa study was an open-label, controlled dose-ranging study designed to assess the safety and efficacy of Xiaflex for the treatment of Stage 2 unilateral idiopathic AC in comparison to an exercise-only ...

CHMP recommends Xarelto (Bayer) for prevention of atherosclerotic events after ACS

The European Committee for Medicinal Products for Human Use (CHMP) has recommended approval of Bayer HealthCare’s oral anticoagulant Xarelto (rivaroxaban) 2.5 mg twice-daily in combination with standard antiplatelet therapy for the prevention of atherothrombotic events (myocardial infarction, cardiovascular death or stroke) after an Acute Coronary Syndrome (ACS) in adult patients with elevated cardiac biomarkers. Elevated cardiac biomarkers confirm the ...

Positive Phase III results for tedizolid phosphate (Trius Therapeutics) for ABSSSI

Trius Therapeutics, Inc. has announced top-line results from its ESTABLISH 2 Phase III clinical trial of tedizolid phosphate (TR-701) for the treatment of Acute Bacterial Skin and Skin Dtructure Infections (ABSSSI), including methicillin resistant Staphylococcus aureus (MRSA). As in the ESTABLISH 1 study, which tested the oral dosage form of tedizolid, the ESTABLISH 2 intravenous to oral transition study ...

Shire acquires SARcode Bioscience and Phase III lifitegrast for Dry Eye Disease

Shire plc will acquire SARcode Bioscience Inc., which brings a new phase III compound – Lifitegrast – currently under development for the signs and symptoms of Dry Eye Disease, into Shire’s portfolio. Shire anticipates launching lifitegradt in the United States as early as 2016 pending a positive outcome of the phase III clinical development program and regulatory approvals. Shire is ...

FDA approves AdreView (GE HealthCare) for gamma scintigraphic assessment of Heart Failure

The FDA has on 22 March 2013, approved an extension to the indication of AdreView (Iobenguane I 123 Injection) from GE HealthCare for the scintigraphic assessment of Myocardial Sympathetic Innervation (cardiac nerve activity) to assist in the evaluation of patients with New York Heart Association (NYHA) Class II or Class III Heart Failure and Left Ventricular Ejection Fraction (LVEF) ...

CHMP recomends Iclusig (Ariad Pharma) for CML and Ph+ALL

Ariad Pharmaceuticals, Inc. has announced that the Committee for Human Medicinal Products (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion on the marketing authorization application for Iclusig (ponatinib) for two indications: • The treatment of adult patients with chronic phase, accelerated phase or blast phase Chronic Myeloid Leukaemia (CML) who are resistant to dasatinib or nilotinib; ...

CHMP recommends Stribild (Gilead Sciences) for the treatment of HIV

Gilead Sciences, Inc. has announced that the Committee for Medicinal Products for Human Use (CHMP), has adopted a positive opinion on the company's Marketing Authorisation Application (MAA) for the once-daily, single tablet regimen Stribild for the treatment of HIV-1 infection in adult patients who are antiretroviral-naïve or are infected with HIV-1 without known mutations associated with resistance to any of ...

CHMP restricts use of Pletal(Otsuka)and Ekistol(Lacer) to treat Intermittant Claudication

The European Medicines Agency’s Committee on Medicinal Products for Human Use (CHMP) has recommended that the use of cilostazol-containing medicines in the treatment of Intermittent Claudication – a condition where poor blood supply to the leg muscles causes pain and affects the ability to walk – should be restricted with a range of new measures aimed at targeting a ...

CRLX 101 (Cerulean Pharma) fails in Phase II trial for NSCLC

A randomized Phase IIb study of CRLX 101, from Cerulean Pharma, in patients with advanced Non-Small Cell Lung Cancer (NSCLC) did not meet its primary efficacy endpoint, overall survival benefit. Patients in the trial had measureable disease, previously progressed through one or two different regimens of chemotherapy, and had evidence of disease progression prior to enrollment.

The study enrolled 157 ...

FDA Advisory Committee recommends Probuphine to treat Opiod Dependence

Titan Pharmaceuticals, Inc. has announced that the majority of Psychopharmacologic Drugs Advisory Committee (PDAC) of the FDA members recognized the favorable benefit-risk profile of Probuphine and voted for approval (10 positive votes, 4 negative votes and 1 abstention) in favour of approval.

Probuphine is a long-acting, subdermal implant formulation of buprenorphine for the maintenance treatment of adult patients ...

FDA approves TOBI Podhaler (Novartis) for treatment of Cystic Fibrosis infections

The FDA has approved TOBI Podhaler (tobramycin inhalation powder) from Novartis on 22 March 2013 for the management of Cystic Fibrosis patients with Pseudomonas aeruginosa, a bacterium that causes lung infections.

TOBI Podhaler was approved in the EU for treatment of pseudomonas lung infection in Cystic Fibrosis patients in July 2011.

Study shows Neupro (UCB) improves GI symptoms in Parkinsons patients

A study shows that when Parkinson's disease (PD) patients are switched from an oral PD medication to Neupro (Rotigotine Transdermal System), from UCB, they reported improvements in pre-existing gastrointestinal symptoms (GI) symptoms. Primary efficacy outcomes included changes in GI symptoms (measured by a visual analogue scale) and the sum score of GI complaints (six items each rated 0-12), in addition ...

CHMP recommends Aubagio (Sanofi/Genzyme) for Multiple Sclerosis

Sanofi and its subsidiary Genzyme have announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion regarding the approval of once-daily, oral Aubagio (teriflunomide) for the treatment of adult patients with relapsing-remitting Multiple Sclerosis (MS). The CHMP did not recommend that Aubagio receive a new active substance ...

HyQvia (Baxter/Halozyme) is CHMP recommended for treatment of Immunodeficiencies

Baxter International and Halozyme Therapeutics, Inc. have announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (EMA CHMP) has granted a Positive Opinion to Baxter for the use of HyQvia (solution for subcutaneous use) as replacement therapy for adult patients with primary and secondary Immunodeficiencies.

The product is a combination of human normal immunoglobulin (IGSC, ...

Phase II trial of OHR/AVR118 (Ohr Pharmaceutical) shows some benefits for cancer patients with Cachexia

Results of a Phase II trial to evaluate the effects of OHR/AVR118, from Ohr Pharmaceutical, in advanced Cancer patients with Cachexia, show the drug offers some benefits. Eighteen patients, three with stage III and fifteen with stage IV cancers completed the treatment protocol. While the primary trial end point of weight gain was not achieved, at the completion of treatment, ...

Study shows RoActemra/Actemra (Genetech/Roche) superior to Humira in achieving remission in Rheumatoid Arthritis patients

New data confirms RoActemra/Actemra (tocilizumab), from Genetech/Roche, is superior to Humira (adalimumab) in achieving disease remission in Rheumatoid Arthritis patients when either is used without methotrexate (MTX). Data shows that over 50% of RA patients can achieve low disease activity or remission with RoActemra/Actemra, compared to under 20% of those treated with the most widely prescribed anti-TNF Humira when neither ...

FDA Advisory Committee recommends MitraClip (Abbott Vascular)to treat Mitral Regurgitation

The FDA Circulatory System Devices Panel of the Medical Devices Advisory Committee has on 20 March 2013, voted by majority (Yes: 5, No: 3) that the benefits of treatment with the MitraClip device from Abbott Vascular, outweigh its risks in patients with significant symptomatic mitral regurgitation (MR) who have been determined by a cardiac surgeon to be too high ...

CHMP rejects Defitelio (Gentium/SOBI)for Hepatic Veno- Occlusive disease

On 21 March 2013, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Defitelio (defibrotide) from Gentium/Swedish Orphan Biovitrium)intended for the treatment and prevention of Hepatic Veno-Occlusive disease in blood stem cell transplantation therapy. The drug was withdrawn from the FDA in August 2011.

Early start/Late start laquinimod (Teva) in ALLERGO extension trial for MS

Teva Pharmaceutical Industries Ltd. and Active Biotech have announced top-line results from the open-label extension of the Phase III ALLEGRO study that assessed the progression of disability and safety of oral laquinimod in early versus delayed-start relapsing-remitting multiple sclerosis (RRMS) patients. The study compared the effectiveness of laquinimod in patients who received 36 months (early-start) versus those who received 24 ...

FDA approves Dotarem (Guerbet SA) for MRI Imaging

The FDA has on 20 March 2013 approved Dotarem (gadoterate meglumine) from Guerbet SA, for use in Magnetic Resonance Imaging (MRI) of the brain, spine and associated tissues of patients ages 2 years and older.

Dotarem is the only macrocyclic and ionic gadolinium-based contrast agent (GBCA) for the intravenous use with magnetic resonance imaging (MRI) in the brain (intracranial), spine ...

New analysis shows Gilenya (Novartis) offers significant benefits in Multiple Sclerosis over four years of treatment

Analysis of three Phase III trials shows Gilenya (fingolimod), from Novartis, offers significant benefits in patients with Multiple Sclerosis after four years of treatment. A new analysis of over 3,600 patients from three large Phase studies (TRANSFORMS, FREEDOMS, and FREEDOMS II) shows that Gilenya offers a significant reduction in the rate of brain volume loss vs. a comparator – by ...

NICE now recommends Esbriet (InterMune) for idiopathic Pulmonary Fibrosis

InterMune submitted additional evidence of benefit after NICE (The National Institute of Health and Clinical Excellence) rejected Esbriet (pirfenidone) as a treatment for patients with idiopathic Pulmonary Fibrosis.InterMune agreed to revise its patient access scheme.

NICE now recommends Esbriet for use in patients who have a Forced Vital (Lung) Capacity of between 50% and 80% predicted.The cost was ...

NICE rejects Afinitor (Novartis) for HER-2 negative, hormone receptor-positive Breast Cancer

NICE(The National Institute of Health and Clinical Excellence)in a provisional draft guidance has rejected Afinitor ((everolimus) from Novartis, for the treatment of HER-2 negative, hormone receptor-positive Breast Cancer. Patients with this condition have an average of 18-36 months to live from diagnosis and Afinitor is the first treatment offering a positive effect on the condition that affects 30,000 women ...

Phase IIa trial of AFN 1252 (Affinium Pharma) shows drug is effective and safe against Bacterial Infections

Results from a Phase IIa clinical trial evaluating oral AFN 1252, from Affinium Pharma, in acute Bacterial Skin and Skin Structure Iinfections (ABSSSI), demonstrates the drug offers excellent efficacy and safety. This study involved 103 patients with infections due to Staphylococcus, dosed twice daily for 5-14 days. The results show that Day 3 Improvement was achieved in 94% of patients ...

RTS,S Malaria Vaccine (GSK) disappoints

The effectiveness of a Malaria Vaccine, RTS,S, developed by GlaxoSmithKline wanes over time, with the shot protecting only 16.8 percent of children over four years, according to trial data. The disappointing results for RTS,S - the world's first potential malaria vaccine - raise further questions about whether it can make a difference in the fight against the disease, a major ...

Study shows Picato (Leo Pharma) provides sustained clearance of Actinic Keratosis at 12 months

Results of long-term clearance rates of Actinic Keratosis lesions after treatment with Picato (ingenol mebutate gel), from Leo Pharma, demonstrated that patients showing sustained complete clearance at 12 months, was 46 per cent (n=108) on the face and scalp and 44 per cent (n=76) on the trunk or extremities.

The secondary outcome showed that patients in the overall population experienced ...

BromSite(InSite Vision) success in Phase III trial for Cataract Surgery

InSite Vision Incorporated has announced top-line results from its recently completed Phase III clinical trial of BromSite(ISV-303) for the reduction of inflammation and pain after Cataract Surgery. BromSite achieved statistically significant superiority compared to vehicle in alleviating ocular pain and inflammation among patients following Cataract Surgery. InSite Vision plans to rapidly initiate the second Phase III trial of BromSite in ...

Phase III results using E 5564 (Eisai) show no significant benefit for Sepsis

A Phase III trial to evaluate the safety and efficacy of E 5564 (eritoran), from Eisai, in reducing mortality in patients with severe Sepsis shows the drug failed to demonstrate a significant effect on reducing all-cause 28-day mortality or 1-year mortality, compared with placebo. The randomized, multinational trial was conducted in 197 intensive care units. Patients were enrolled from June ...

Phase III success for talimogene laherparepvec (Amgen) in Melanoma

Amgen has announced top-line results from the Phase III trial in Melanoma, which evaluated the efficacy and safety of talimogene laherparepvec for the treatment of unresected stage IIIB, IIIC or IV Melanoma compared to treatment with subcutaneous granulocyte-macrophage colony-stimulating factor (GM-CSF).

The study met its primary endpoint of durable response rate (DRR), defined as the rate of complete or ...

Tradjenta in Phase III trial for Diabetic Nephropathy

Boehringer Ingelheim and Eli Lilly and Company have initiated a study of the efficacy and safety of Tradjenta ( linagliptin) in patients with Type 2 Diabetes with prevalent albuminuria (defined as urinary albumin-to-creatinine ratio (UACR) 30-3000 mg/g creatinine), while remaining on current standard therapy for Diabetic Nephropathy.

The name of the clinical trial is MARLINA (efficacy, safety & Modification ...

EU approves GelrinC (Regentis Biomaterials) for Cartilage Repair

Regentis Biomaterials has received European CE Mark approval for its GelrinC biodegradable implant, for Cartilage Repair. GelrinC is suitable for patients with traumatic knee injuries. It is inserted as a liquid to fill any shape of cartilage defect and it is then converted into a solid through exposure to ultra-violet light. GelrinC's matrix of synthetic polyethylene glycol diacrylate and denatured ...

Orbit Artherectomy System (Cardiovascular Systems) filed at FDA to treat Calcified Arteries

Cardiovascular Systems (CSI) has announced it has submitted its Premarket Approval (PMA) application to the FDA for its Orbital Atherectomy System, used to treat calcified coronary arteries.

The completed PMA application marks another major coronary milestone for CSI, following the release of ORBIT II pivotal trial results at the recent 2013 American College of Cardiology (ACC) conference. CSI's technology ...

Phase III study shows Cialis (Eli Lilly) plus finasteride provides benefits for Benign Prostatic Hyperplasia

A new Phase III study showed Cialis (tadalafil), from Eli Lilly and Co, co-administered with finasteride significantly improved scores on the International Prostate Symptom Score (IPSS), compared to placebo/finasteride, in men with lower urinary tract symptoms of Benign Prostatic Hyperplasia (LUTS/BPH) and enlarged prostates. On a pre-specified secondary measure, Cialis/finasteride also improved erectile function scores versus placebo/finasteride in those men ...

European Commission approves Jetrea (Alcon/Novartis) to treat Vitreomacular Traction

Alcon,a division of Novartis, has announced that the European Commission has approved Jetrea (intravitreal injection ocriplasmin) in the EU for the treatment of Vitreomacular Traction (VMT), including when associated with macular hole of diameter less than or equal to 400 microns. VMT is often responsible for progressive sight-threatening symptoms and irreversible vision loss, and is estimated to affect between ...

Firmagon (Ferring)shows lower CV risks in treatment of Prostate Cancer

Data presented at the European Association of Urology 2013 annual meeting in Milan, indicate that the gonadotropin releasing hormone (GnRH) antagonist Firmagon (degarelix) from Ferring, may be associated with lower risk of a cardiovascular (CV) event or death compared to commonly prescribed luteinising hormone-releasing hormone (LHRH) agonists.

These data are based on a pooled analysis of 2,328 ...

IQWiG rejects Eylea for treatment of "wet" Age Related Macular Degeneration

Germany's Institute for Quality and Efficiency in Health Care (IQWiG) reported in a preliminary benefit assessment that Eylea (aflibercept) from BayerHealthCare has "no additional benefit" over Lucentis(ranibizumab), the comparator requested by Germany's Federal Joint Committee (G-BA) to treat wet age-related macular degeneration (AMD). The institute said the data Bayer submitted comparing Eylea and Lucentis were "not suitable" because Lucentis was ...

Orexo sells US rights to Abstral to Galena Biopharma

Orexo AB has announced that it sold Abstral (fentanyl) Sublingual Tablets in the United States to Galena Biopharma, Inc. Under the terms of the agreement, Galena Biopharma will pay Orexo US$10 million upfront and an additional US$5 million within the first twelve months after signing, plus low double digit royalties and milestone payments based on pre-specified sales levels.

Abstral ...

Pegasys (Roche) European indication expanded by EMA in Hepatitis C to include to children

Roche has announced that the European Medicines Agency (EMA) has expanded the approval of Pegasys (peginterferon alfa-2a) plus ribavirin for the treatment of chronic Hepatitis C virus (HCV). The new label includes children and adolescents five years of age and older, who have not received treatment and who have tested positive for the virus. Pegasys in combination with the antiviral ...

Inspra(Pfizer) success in REMINDER trial for acute STEMI patients

Pfizer Inc. announced results from the REMINDER trial of Inspra (eplerenone) showing statistically significant risk reductions in the primary composite efficacy endpoint. The composite endpoint was defined as the time to first event of cardiovascular (CV) mortality, re-hospitalization or extended initial hospital stay due to diagnosis of Heart Failure (HF), sustained ventricular tachycardia or fibrillation, ejection fraction (EF) 40% ...

EU approves Carotid Embolic Protection Stent (InspireMD) for Stroke prevention

InspireMD's Carotid Embolic Protection Stent has received CE mark approval in the EU. It is based on MicroNet mesh technology, designed to provide procedural and post-procedural distal embolic protection in carotid artery stenting procedures to reduce the risk of Stroke. The MicroNet is designed to hold plaque and thrombus in place against the wall of the blocked artery, preventing debris ...

New studies support the benefits of Betmiga/Myrbetriq (Astellas) for treating Overactive Bladder

New results from clinical trials of Betmiga (mirabegron), from Astellas, support the drug's good safety and tolerability profile in treating patients with Overactive Bladder. The first of the analyses – pooled from three randomised, placebo-controlled, double-blind, 12 week trials involving a total of 4,611 patients – shows there was a four-times lower incidence of dry mouth and pruritus in patients ...

FDA warning on incretin mimetic drugs for Type 2 Diabetes

The FDA is reviewing unpublished findings by a group of academic researchers that suggest pre-cancerous cellular changes may be associated with Type 2 Diabetes drugs called incretin mimetics.

The findings suggest the class of medicines may be linked to the risk of developing an inflammation of the pancreas tied to cancer and kidney failure that was previously reported ...

Phase III trial of Aranesp (Amgen) in anemic Heart Failure patients shows drug offers no real benefit

Results from the RED-HF trial involved 2,278 anemic Heart Failure patients given either Aranesp (darbepoetin alfa), from Amgen, or placebo shows the drug does not improve patients' health, nor does it reduce their risk of death from Heart Failure. In the darbepoetin alfa group, 50.7 percent of the patients experienced death from any cause or hospitalization for worsening Heart Failure. ...

Positive topline results from Phase III trial of Enterovirus 71 vaccine (Sinovac Biotech) against Hand, Foot and Mouth Disease

Preliminary top-line data from a Phase III clinical trial assessing the efficacy, immunogenicity and safety of Enterovirus 71 vaccine, from Sinovac Biotech, against Hand, Foot and Mouth Disease, showed that the vaccine was 95.4% efficacious against HFMD. The Phase III trial involving 10,000 healthy infants of 6 to 35 months old showed good immunogenicity and safety.

The overall incidence of ...

STREAM Trial shows that Metalyse/TNKase (Boehringer) offers some benefits in STEMI patients

Results from the STREAM trial of 1,915 patients with ST-elevation myocardial infarction (STEMI), given Metalyse/TNKase (tenecteplase), from Boehringer, indicates that the drug offers some benefits compared to alternative PCI treatment. Patients were seen in community hospitals or by emergency medical personnel where angioplasty was not possible. Before transfer, subjects were randomized to either percutaneous coronary intervention immediately after arrival or ...

Study shows Metalyse/TNKase (Boehringer) benefits patients with Pulmonary Embolism

A new study shows that in patients with Acute Pulmonary Embolism, Metalyse/TNKase (tenecteplase), from Boehringer, prevents death or circulatory collapse and is particularly effective for patients aged below 75 years. The prospective, randomized, double blind PEITHO study enrolled 1,006 patients with confirmed APE. Patients were assigned heparin plus tenecteplase or heparin plus placebo. The primary endpoint was death from any ...

Vanda Pharmaceuticals withdraws EU MMA for Fanaptum to treat Schizophrenia

Vanda Pharmaceuticals has withdrawn its Marketing Authorization Application (MAA) submitted to the EMA's Committee for Medicinal Products for Human Use (CHMP) for Fanaptum (oral iloperidone tablets) for the treatment of adult patients with Schizophrenia. This withdrawal is based on a request by the CHMP/Rapporteur/Co-rapporteur for Vanda to submit the results from an ongoing relapse prevention, randomized iloperidone-placebo withdrawal study in ...

Dymista(Meda AB) is EU approved via decentralised procedure for Allergic Rhinitis

Dymista (azelastine hydrochloride and fluticasone propionate)from Meda AB has received medical approval in Europe via the decentralized registration procedure. Dymista is approved for the treatment of seasonal and perennial Allergic Rhinitis and is now approved by the MHRA in the UK .

National registration processes, including negotiations regarding pricing and reimbursement, will now follow in each country prior ...

Enobosarm (GTx) is published in The Lancet Oncology

The Lancet Oncology, has published online ahead of its April print edition the results from the randomized, double-blind, placebo-controlled Phase II clinical trial of Enobosarm from GTx to assess its effects on Muscle Wasting and physical function in patients with cancer.

Enobosarm (GTx-024) is a selective androgen receptor modulator (SARM), a new class of non-steroidal, tissue-specific anabolic agents that ...

EU approves expanded approval for Qutenza (Astellas) for Neuropathic Pain

The European Commission has approved expanded options for pre-treatment prior to use of Qutenza (8% capsaicin patch), from Astellas. Before application the patient may now take an oral analgesic, or the treatment area may be pre-treated with a topical anaesthetic. The 8% capsaicin patch is the first and only licensed high concentration (8%) capsaicin cutaneous patch for the treatment of ...

CHAMPION PHOENIX Phase III trial of cangrelor (Medicines Company) success in PCI

The Medicines Company has reported results of CHAMPION PHOENIX, a 11,145 patient Phase III randomized, double-blind clinical trial comparing the Company's intravenous antiplatelet cangrelor to oral clopidogrel in patients undergoing Percutaneous Coronary Intervention (PCI).

Patients treated with cangrelor had a 22% (p=0.005) reduced odds of experiencing the primary endpoint, which was a composite incidence of death, myocardial infarction (MI), ...

FDA approves Lymphoseek (Navidea Biopharma) for intraoperative Lymphatic Mapping

The FDA has approved on 13 March 2013, Lymphoseek (technetium Tc 99m tilmanocept) Injection, from Navidea Biopharmaceuticals , a radioactive diagnostic imaging agent that helps doctors locate lymph nodes in patients with Breast Cancer or Melanoma who are undergoing surgery to remove tumor-draining lymph nodes.

Lymphoseek is an imaging drug that helps locate lymph nodes; it is not ...

Phase II study of CYT003 (Cytos Biotechnology) for Allergic Asthma meets all end points

Results from a Phase IIa clinical trial with CYT003 (vaccine), from Cytos Biotechnology, show the Allergic Asthma treatment has met all its end points. The study is a randomized, double-blind, placebo-controlled trial in patients requiring long-term treatment with inhaled corticosteroids (ICS). The study recruited 63 patients who received 7 weekly to bi-weekly subcutaneous injections, with efficacy assessment during 12 weeks. ...

Biogen IDEC files rFVIII Fc at FDA for treatment of Haemophilia A

Biogen Idec has announced that the company has submitted a Biologics License Application (BLA) to the FDA for the marketing approval of recombinant factor VIII Fc fusion protein (rFVIIIFc) for the treatment of Haemophilia A. Recombinant FVIIIFc is the first Haemophilia A product candidate in a new class of long-lasting clotting factor therapies being developed with the goal of ...

Phase III study of perifosine (Aeterna Zentaris )for Multiple Myeloma discontinued

Aeterna Zentaris Inc. has announced that an independent Data Safety Monitoring Board ("DSMB") has recommended discontinuing the ongoing Phase III study comparing the efficacy and safety of perifosine to placebo when combined with bortezomib (Velcade) and dexamethasone in patients with relapsed or relapsed/refractory Multiple Myeloma. Based on the outcome of its pre planned interim analysis of efficacy and safety, ...

Positive results in three-year trial of Absorb Vascular Scaffold (Abbott)

Three-year results from 101 patients treated with the Absorb Vascular Scaffold (bioresorbable everolimus eluting stent system), from Abbott, in the second stage of the ABSORB trial show that improvements are seen in blood vessel movement and area inside the vessel where the scaffold was placed. Results showed the rate of major adverse cardiovascular events (MACE) in 101 patients was 10 ...

Promus Element stent (Boston Scientific) continues to outperform the Xience V stent at 3 years

At three years, the Promus Element everolimus eluting stent, from Boston Scientific, continued to demonstrate advantages for CAD patients over the Xience V Stent. The trial reported a three-year target lesion revascularization (TLR) rate of 3.5 percent for the Promus Element Stent, the lowest TLR rate in any pivotal FDA approval trial, compared to 4.9 percent for the Xience V ...

Ranexa(Gilead Sciences) success in Phase IV TERISA trial to treat Chronic Stable Angina in diabetic patients.

Gilead Sciences, has announced data from the Phase IV TERISA (Type 2 Diabetes Evaluation of Ranolazine In Subjects With Chronic Stable Angina) study, which demonstrated that the addition of Ranexa (ranolazine) to background antianginal therapy in chronic angina patients with Type 2 Diabetes significantly reduced the frequency of weekly angina episodes compared to placebo and background antianginal therapy. Results ...

Trial of Stentys self-apposing stent (Stentys) demonstrates low mortality rates in CAD patients

One-year results of the APPOSITION III clinical trial in 1000 CAD patients post treatment of a severe heart attack show that the Stentys Self-Apposing Stent, from Stentys, demonstrates low mortality rates in patients. The APPOSITION III trial is a prospective single-arm multi-center study designed to assess the long term performance of Stentys Self-Apposing Stents in routine clinical practice in Europe ...

Xarelto(Bayer/Janssen) initiates trial for non valvular Atrial Fibrillation

Bayer HealthCare announced the initiation of the PIONEER AF-PCI study, a Phase IIIb clinical study of its oral anticoagulant Xarelto (rivaroxaban) to investigate how best to treat patients with non-valvular Atrial Fibrillation who undergo Percutaneous Coronary Intervention with stent placement.

The PIONEER AF-PCI study will enroll approximately 2,100 patients worldwide. The trial will assess the safety of two ...

MitraClip System (Abbott Vascular) success in EVEREST II trial for reatment of Mitral Regurgitation

Abbott announced data from the EVEREST II (Endovascular Valve Edge-to-Edge REpair STudy) High Surgical Risk cohort evaluating the company's first-in-class catheter-based MitraClip System for the treatment of Mitral Regurgitation (MR). Findings were presented at the 62nd Annual Scientific Session of the American College of Cardiology in San Francisco

Results showed: A 30-day mortality rate significantly lower than ...

Phase III SAILING study of dolutegravir(ViiV) success in HIV-1

ViiV Healthcare has announced 24-week data from the Phase III SAILING (ING111762) study evaluating the investigational integrase inhibitor dolutegravir in patients with HIV-1 who are failing on current therapy, but had not been treated with an integrase inhibitor.

At 24 weeks, 79% of study participants receiving the once-daily dolutegravir regimen were virologically suppressed (HIV-1 RNA <50 c/mL) vs. ...

PREVAIL trial of Watchman LAAC (Boston Scientific) shows some benefits for AF patients

New results on the PREVAIL trial, which randomized 407 patients with nonvalvular Atrial Fibrillation to either LAA closure with the Watchman device, from Boston Scientific or warfarin, indicates the study has met 2 of its 3 primary end points. Data shows that the device was implanted more successfully in the trial (95.1%) than in 2 prior Watchman studies: PROTECT AF ...

Tredaptive (Merck Inc) fails to meet primary end point in HPS2-THRIVE Dyslipidaemia trial

Detailed results of HPS2-THRIVE, a study of Tredaptive (nicotinic acid plus laropiprant), from Merck Inc, in 25673 patients with Dyslipidaemia suggests adding Tredaptive to statin therapy did not significantly further reduce the risk of major vascular events. In the trial the composite primary endpoint of major vascular events (coronary death non-fatal heart attack stroke or any arterial revascularization) occurred in ...

IQWiG finds no clear benefit of using PET/CT for patients with Bone or Soft Tissue Tumours

The German Institute for Quality and Efficiency in Health Care (IQWiG) has found no robust conclusions as to the benefits of using PET alone or in combination with CT for patients with Bone and Soft Tissue Tumours. IQWiG searched the international literature for studies that had examined the consequences of a diagnostic intervention using PET or PET/CT on health aspects ...

MRI-guided focal laser ablation system (Visualase) shows promise in patients with Prostate Cancer

A small Phase I trial of an MRI-guided focal laser ablation system, from Visualase, designed to treat the diseased portion of the Prostate in patients with Prostate Cancer, suggests the technique is safe and can be performed without the troubling complications associated with more aggressive therapies. This study enrolled nine men with biopsy-confirmed, low-risk Prostate Cancers with an MRI of ...

Takeda files vedolizumab at EMA for Crohns and Ulcerative Colitis

Takeda Pharmaceutical Company Limited has announced that a Marketing Authorisation Application (MAA) has been submitted to The European Medicines Agency (EMA) for vedolizumab, an investigational, gut-selective humanized monoclonal antibody for the treatment of adults with moderately to severely active Ulcerative Colitis (UC) and Crohn’s disease (CD), the two most common types of inflammatory bowel disease (IBD). If approved, vedolizumab would ...

Xarelto enters Phase III trial for Heart Failure and CAD

Bayer HealthCare and Janssen Research & Development, LLC announced the initiation of COMMANDER-HF, a pivotal Phase III clinical trial that will evaluate Xarelto (rivaroxaban) 2.5 mg twice daily in patients with Chronic Heart Failure (HF) and significant coronary artery disease (CAD). Rivaroxaban is the first novel oral anticoagulant to be evaluated in this patient group who remain at high-risk for ...

German Federal Joint Committee decides additional benefit of Fycompa (Eisai) unproven as a treatment for Epilepsy

The German Federal Joint Committee (G-BA), the decision-making body of the self-governing medical system in Germany, has announced that it considers the additional benefit of Fycompa (perampanel) unproven when compared to two other treatments. Perampanel is indicated as an adjunctive treatment of partial-onset seizures with or without secondarily generalised seizures in patients with epilepsy aged 12 years and older.

This ...

GSK files Eperzan (albiglutide) at EMA for treatment of Type 2 Diabetes

GSK has announced the submission of a Marketing Authorisation Application for albiglutide, with the proprietary name Eperzan to the European Medicines Agency. Albiglutide is an investigational once-weekly treatment for adult patients with Type 2 Diabetes which is not yet approved anywhere in the world.

On 14th January 2013, GSK announced the submission of a regulatory application in the ...

Paion AG initiates Phase II trial of remimazolam for Anaesthesia

Paion AG will conduct a Phase II trial with short acting anaesthic/sedative remimazolam in general anaesthesia in cardiac surgery in the second half of 2013.Ono Pharma have completed a successful Phase II trial for remimazolam in Japan in general aneasthesia and are conducting a Phase II/III trial.

The clinical studies performed with remimazolam comprise four Phase I and three Phase ...

Phase IV study of Livalo (Eli Lilly/Kowa Pharmaceuticals) meets end point in patients with Dyslipidemia

Results of a Phase IV study evaluating the efficacy of Livalo (pitavastatin), from Eli Lilly/Kowa Pharmaceuticals, compared with pravastatin in reducing low-density lipoprotein cholesterol (LDL-C) in HIV-infected adults with Dyslipidemia has met its end point. Results showed that, after 12 weeks of therapy, pitavastatin had a significantly greater decrease in LDL-C compared with pravastatin (pitavastatin -49.4 mg/dL and pravastatin -33.6 ...

Study reveals mechanism providing benefit of omega-3 fatty acids on Cardiovascular health

A new study has uncovered a mechanism by which omega-3 fatty acids can benefit Cardiovascular health. Prof. Heinemann (Jena University), Prof. Dr. Michael Bauer (Jena University Hospital) and Prof. Dr. Toshinori Hoshi (University of Pennsylvania) have shown that the 'SLO1' potassium channel is an important component in the effectiveness of omega-3 fatty acids. These ionic channels act like very specific ...

EMA approves Perjeta ( Roche) for treatment of metastatic Breast Cancer

Roche has announced that the European Medicines Agency (EMA) has approved Perjeta(pertuzumab) for patients with previously untreated HER2-positive metastatic Breast Cancer (mBC). Perjeta is approved in combination with Herceptin (trastuzumab) and docetaxel in adult patients with HER2-positive metastatic or locally recurrent unresectable Breast Cancer, who have not received previous anti-HER2 therapy or chemotherapy for their metastatic disease.

The ...

Lundbeck and Otsuka expand collaboration relating to Abilify

Lundbeck and Otsuka now expand their existing collaboration to include promotion of Abilify (aripiprazole) in 14 European countries starting April 1, 2013. Under the agreement, Otsuka and Lundbeck will jointly promote Abilify in Denmark, Finland, Germany, Italy, Spain, Sweden and the United Kingdom. Lundbeck will promote Abilify in Austria, Belgium, Ireland, Netherlands, Poland, Portugal and Romania. The agreement provides ...

NICE now recommends Xolair (Novartis) for Allergic Asthma

NICE,the National Institute for Health and Clinical Excellence said it now recommends Xolair (omalizumab) from Novartis as an option for treating severe, persistent Allergic Asthma in adults, adolescents and children, in a complete change from its earlier intention to exclude it from the NHS.

Reanalysis of a trial of LipiGesic M (PuraMed Bioscience) suggests treatment is effective for Migraine

A reanalysis of clinical trial results of homeopathic formulation, LipiGesic M (feverfew and ginger), from PuraMed Bioscience, confirms that the Migraine medication can provide effective relief. The original double-blind, placebo-controlled clinical trial for LipiGesic M, completed in 2010 and published in the July 2011 issue of Headache: The Journal of Head and Face Pain, concluded that 64 percent of patients ...

FDA Advisory Committee rejects low dose mesylate salt of paroxetine for Menopause

Noven Pharmaceuticals, Inc. has announced that the FDA Reproductive Health Drugs Advisory Committee voted 10 to 4 that the overall risk/benefit profile of low-dose mesylate salt of paroxetine (LDMP; 7.5 mg/day) is not acceptable to support approval. LDMP is an investigational nonhormonal treatment specifically developed for moderate to severe vasomotor symptoms (VMS) associated with menopause.

FDA Advisory Committee rejects Sefelsa(Depomed)as a treatment for Menopause

Depomed, Inc. has announced that the Reproductive Health Drugs Advisory Committee (RHDAC) of the FDA voted 2-12 against approval for Sefelsa, Depomed's investigational, oral, twice daily formulation of gabapentin, to treat moderate to severe vasomotor symptoms due to Menopause. Sefelsa is the proposed trade name for the medication and was formerly referred to as Serada.

FDA approves OneTouch VerioSync Blood Glucose monitoring system (LifeScan) for patients with Diabetes Types 1 & 2

The OneTouch VerioSync Blood Glucose Monitoring System from LifeScan, has received clearance from the FDA for use by patients with Diabetes Types 1 & 2. It is the first meter to automatically send blood glucose results wirelessly via Bluetooth technology to an iPhone, iPad or iPod touch using the OneTouch Reveal mobile app. Through the OneTouch Reveal mobile app, users ...

FDA rejects again Xarelto ( Janssen/Bayer) for treatment of Acute Coronary Syndrome

The FDA has rejected for the second time, the supplemental new drug application for Xarelto (rivaroxaban) from Janssen Pharma/Bayer as a therapy to reduce the risk of cardiovascular events in patients with Acute Coronary Syndrome (ACS). The drug was rejected last June after the Cardiovascular and Renal Drugs Advisory Committee a month earlier voted 6-4, with one abstention, against approval ...

Phase III success for Vimpat (UCB) as monotherapy for treatment of partial onset seizures

Positive results are announced of a Phase III study designed to evaluate the efficacy and safety of conversion to Vimpat (lacosamide)from UCB as monotherapy in adult patients with partial-onset seizures with or without secondary generalization compared with a historical control.

The study met its primary endpoint demonstrating that the exit rate for patients on lacosamide (400 mg/day) was ...

Positive results from Phase III trial of BI 201335 (Boehringer) for Hepatitis C patients

Interim results from HCVerso, a trial of BI-201335 (faldaprevir), from Boehringer, for Hepatitis C (HCV) showed that 80% of HCV/HIV co-infected patients achieved early treatment success (ETS), as defined by the study protocol. Results were consistent across patients regardless of HIV therapy or prior HCV treatment status, including patients who were HCV treatment-naive or had previously relapsed during HCV treatment ...

Positive results in Phase III trial of Sufentanil NanoTab PCA (AcelRx Pharmaceuticals) for patients with Post-Operative Pain

Top-line data results demonstrating that the first of two pivotal placebo-controlled Phase III studies for sublingual Sufentanil NanoTab PCA (patient-controlled analgesia) System, from AcelRx Pharmaceuticals, met its primary endpoint. The primary endpoint evaluated Pain intensity over the 48-hour study period compared to baseline, or Summed Pain Intensity Difference (SPID-48), in patients following major open abdominal surgery.

Results demonstrated that patients ...

VOICE study of Truvada gel (Gilead Sciences) unsuccessful in HIV prevention

Anti retroviral therapy was applied in the VOICE study which used a vaginal gel containing tenofovir (Viread as a pill) and tenofovir-emtricitabine (Truvada) from Gilead Sciences. None of the treatments was effective in the VOICE study, mostly because patients failed to use the product daily. 315 out of 5029 women in the study were infected by HIV (5.7%).

Investigators ...

Results from Phase II study of CHR 2797 (Cell Therapeutics) for AML published in the Lancet Oncology

Results from the OPAL Phase II study of CHR 2797 (tosedostat), from Cell Therapeutics, in elderly patients with relapsed or refractory Acute Myeloid Leukemia (AML) have been published in the Lancet Oncology. Results were released in 2012. The trial showed that once-daily oral tosedostat resulted in a disease control rate of 51%. Subset analyses suggested the greatest benefit occurred in ...

Phase III study of ATX 101 (Kythera Biopharmaceuticals) shows treatment helps reduce submental fat

Kythera Biopharmaceuticals has announced positive interim results from a Phase IIIb multi-center open-label study (ATX-101-11-26) to evaluate the safety and efficacy of ATX 101 (sodium deoxycholate) for the reduction of unwanted submental fat commonly known as double chin. Results show that 87 percent of patients achieved at least a one-grade improvement from baseline on the Clinician-Reported Submental Fat Rating Scale. ...

EU approves Ilaris (Novartis) to treat Gouty Arthritis

Novartis has announced that the European Commission has approved llaris (canakinumab, ACZ885) in the treatment of patients with acute Gouty Arthritis who suffer frequent attacks, and whose symptoms cannot or should not be managed with current treatment options. Ilaris is the first biologic approved in the EU for symptomatic pain relief in a gouty arthritis indication, and is administered ...

FDA approves Abilify Maintena as a treatment for Schizophrenia

H. Lundbeck A/S and Otsuka Pharmaceutical Co., Ltd. have announced that the FDA has on 28 February 2013 approved Abilify Maintena (aripiprazole) for extended release injectable suspension, an intramuscular (IM) depot formulation indicated for the treatment of Schizophrenia.

Abilify Maintena is the first dopamine D2 partial agonist approved as a once-monthly injection. It contributes a new treatment option to ...

FDA expands approval of Corifact (CSL Behring) to manage surgical bleeding in adult and pediatric patients with Factor XIII Deficiency

The FDA has approved an expansion of the indication for Corifact (factor XIII Concentrate), from CSL Behring, to include the peri-operative management of surgical bleeding in adult and pediatric patients with congenital Factor XIII Deficiency. In 2011, Corifact became the first and only FXIII concentrate approved in the US for the routine prophylactic treatment of congenital factor XIII deficiency. The ...

FDA gives 510(k) approval for the MicroDose SI SPECT imaging system (Philips)

The FDA has given 510(k) clearance for the MicroDose SI system, from Philips, which is a full-field digital mammography (FFDM) system with the capability to enable future Single-Shot Spectral Imaging applications. The MicroDose SI uses digital photon-counting technology, which enables clinicians to conduct exams using low radiation dose without compromising image quality. The technology allows clinicians to see more than ...

Moxduo (QRx Pharma) resubmitted to the FDA for approval for Pain control

QRx Pharma has resubmitted its Moxduo (morphine plus oxycodone) New Drug Application (NDA) to the FDA for the control of Pain. The FDA confirmed that there were no efficacy or safety issues in any of the studies that were part of the original NDA. The resubmitted application, including new results from Study 022, will undergo review by an Advisory Committee ...

Study suggests omega-3 fish oil can help protect against Skin Cancer

Researchers have carried out the first clinical trial to examine the impact of the fish oils on the skin immunity. Results of the study found that taking a regular dose of fish oils boosted skin immunity to sunlight. Specifically, it also reduced sunlight-induced suppression of the immune system, which affects the body’s ability to fight Skin Cancer and infection. Volunteers ...

EU approves Selincro (Biotie/Lundbeck) for treatment of Alcohol Dependence

Biotie has announced that its partner H.Lundbeck A/S (Lundbeck) has received European marketing authorization from the European Commission for Selincro (nalmefene; an opioid system modulator) for the reduction of alcohol consumption in adult patients with Alcohol Dependence. The marketing authorization applies to all 27 European Union member states.

Selincro is a unique dual-acting opioid system modulator and acts on ...

FDA awards "Generally Recognized as Safe" status to Cardioviva (Micropharma) to help reduce bad cholesterol

The FDA have awarded heart health probiotic, Cardioviva (Lactobacillus reuteri NCIMB 30242), from Micropharma Ttd, with "Generally Recognized as Safe" (GRAS) status. This designation signifies that Cardioviva is considered safe by experts to use as an ingredient in food. Of the top 10 probiotic supplements in the US, Cardioviva is one of two to achieve FDA's GRAS approval.

The specific ...

Dalbavancin (Durata Therapeutics) success in Phase III DISCOVER 2 trial for ABSSSI

Durata Therapeutics, Inc. has announced preliminary, top-line results for its DISCOVER 2 ("Dalbavancin for Infections of the Skin COmpared to Vancomycin at an Early Response") Phase III study of dalbavancin, which is under investigation for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible gram-positive bacteria, including methicillin resistant Staphylococcus aureus (MRSA). DISCOVER 2 results ...

EU approves Promus Premier Stent (Boston Scientific) for treating CAD

Boston Scientific has received CE Mark approval for the Promus Premier everolimus-eluting platinum chromium Coronary Stent System, the company's next-generation polymer drug-eluting stent (DES) technology for treating Coronary Artery Disease, and is starting its European market launch. The Promus Premier features a customized Platinum Chromium (PtCr) stent architecture, the everolimus drug coating and fluorinated co-polymer, and an enhanced stent delivery ...

FDA approves Osphena (Shionogi) for Dyspareunia.

The FDA has approved Osphena (ospemifene), from Shionogi, for the treatment of moderate to severe Dyspareunia (painful intercourse), a symptom of Vulvar and Vaginal Atrophy (VVA), due to menopause. The efficacy and safety of Osphena was demonstrated in three clinical trials. Osphena demonstrated significant improvements in Dyspareunia as well as on the physical changes of the vagina associated with menopause. ...

FDA recall of Omontys (Affymax/Takeda) for treatment of Anaemia in adult dialysis patients

The FDA is alerting health care providers and patients of a voluntary nationwide recall of all lots of Omontys Injection (peginesatide) by Affymax, Inc., and Takeda Pharmaceuticals Company Limited. The recall is due to reports of anaphylaxis, a serious and life-threatening allergic reaction. Omontys is used to treat anemia in adult dialysis patients.

Omontys was filed last year at ...

Phase II trial of ToleroMune (Circassia) shows benefits for Cat Allergy two years after treatment

Results of a Phase II clinical study show that a course of just four doses of ToleroMune Cat Allergy therapy (T cell vaccine), from Circassia Ltd, maintained improvements in patients' symptoms two years after the start of treatment. The study originally measured improvements in nasal and ocular allergy symptoms (Total Rhinoconjunctivitis Symptom Score; TRSS) in 202 patients, following treatment with ...

FDA approves Stivarga (Bayer HealthCare) in patients with GIST

The FDA has approved Stivarga (regorafenib), from Bayer HealthCare, to treat patients with locally advanced, unresectable or metastatic Gastrointestinal Stromal Tumor (GIST) who have been previously treated with imatinib mesylate and sunitinib malate. Approval is based on data from the pivotal Phase III GRID trial, which showed that Stivarga plus best supportive care (BSC) statistically significantly improved progression-free survival (PFS) ...

FDA halts pediatric trials of Sensipar(Amgen) for Hyperparathyroidism

The FDA has stopped all pediatric clinical trials of Sensipar (cinacalcet hydrochloride) from Amgen, after the recent death of a 14-year-old patient in a trial. The FDA continues to gather information on the circumstances surrounding the patient’s death. Sensipar is a medication used to decrease the release of parathyroid hormone (PTH) from the parathyroid gland. Sensipar lowers high PTH levels ...

Phase III trial of Naloxegol (AstraZeneca) confirms earlier safety studies in patients with Opioid-induced Constipation

New results from KODIAC-08, an open-label, randomised, 52-week, long-term safety trial of Naloxegol (naxolol), from AstraZeneca, in patients with non-cancer related pain and Opioid-induced Constipation, are similar to safety results seen in earlier Phase III studies. A total of 534 patients received Naloxegol daily for up to 52 weeks, while 270 patients received usual care. The most commonly reported AEs ...

New Phase III trial results of Xolair (Genentech/Roche/Novartis) for patients with Urticaria

Results from a Phase III trial, ASTERIA II, demonstrate that Xolair (omalizumab), from Genentech/Roche and Novartis, met its primary endpoint in patients with moderate to severe chronic Idiopathic Urticaria (CIU), who remained symptomatic despite treatment with approved H1 antihistamine doses. The primary endpoint was measured using a 21-point scale known as a weekly Itch Severity Score (ISS). Three dose groups ...

Analysis of two Phase III studies shows Spiriva (Boehringer) provides benefits for Asthma patients

New data from two UniTinA-asthma studies of Spiriva (tiotropium bromide), from Boehringer, shows that the drug improved lung function and Asthma control in patients with poorly controlled Asthma, irrespective of their allergic status. The two studies were replicate double-blind parallel-group trials involving a total of 912 patients, who were randomized to receive tiotropium 5 mcg or placebo in addition to ...

NICE rejects extended use of Alimta (Eli Lilly) in NSCLC

NICE (The National Institute of Health and Clinical Excellence) has not recommended Alimta (pemetrexed) from Eli Lilly for use as a maintenance treatment for Non-Small-Cell Lung Cancer (NSCLC) following induction therapy with pemetrexed and cisplatin in its preliminary guidance.

NICE had given its recommendation to the drug as a first line treatment option for NSCLC and as a maintenance ...

CHMP recommends Hexyon/Hexacima vaccine (Sanofi Pasteur)

The CHMP has recommended market approval for the 6-in-1 pediatric vaccine Hexyon/Hexacima (DTaP-IPV-Hib-HepB vaccine), from Sanofi Pasteur. The new vaccine will be commercialized under the brand name Hexyon in Western European countries by Sanofi Pasteur MSD, the joint venture between MSD and Sanofi Pasteur, and under the brand name Hexacima in Eastern European countries by Sanofi Pasteur. The new vaccine ...

FDA approves Kadcyla (Genentech/Roche) for HER2-positive metastatic Breast Cancer patients

The FDA has approved Kadcyla (trastuzumab emtansine), from Genentech/Roche, for the treatment of people with HER2-positive metastatic Breast Cancer (mBC) who have received prior treatment with Herceptin (trastuzumab) and a taxane chemotherapy. The approval is based on results from EMILIA, a Phase III randomized study comparing Kadcyla to lapatinib in combination with Xeloda (capecitabine) in 991 people with HER2-positive Breast ...

New data shows benefits of Linx Reflux System (Torax Medical Inc) for patients with GERD

A new study provides evidence of safety and effectiveness for the Linx Reflux Management System, from Torax Medical Inc, for the treatment of patients with GERD. This prospective, multicenter trial is part of the FDA pre-market approval process. The patients were evaluated before and after treatment to determine the effect of the Linx System on their GERD using pre-defined success ...

Adasuve ( Alexza/Ferrer) is EU approved to control agitation in Schizophrenia patients

Alexza Pharmaceuticals, Inc.and Grupo Ferrer Internacional, S.A.,announced that the European Commission has granted marketing authorization for Adasuve (Staccato loxapine). In the European Union (EU), Adasuve 4.5 mg and 9.1 mg inhalation powder loxapine, pre-dispensed, is authorized for the rapid control of mild-to-moderate agitation in adult patients with schizophrenia or bipolar disorder

The Adasuve marketing authorization requires that patients receive ...

Chelsea to re-file Northera at FDA for Symptomatic Neurogenic Orthostatic Hypotension

Chelsea Therapeutics International, Ltd. has received written guidance from the Director of the Office of New Drugs at the FDA stating that Study 306B has the potential to serve as the basis for a resubmission of a Northera (droxidopa) New Drug Application (NDA) for the treatment of Symptomatic Neurogenic Orthostatic Hypotension (NOH). The guidance suggests that "data strongly demonstrating ...

Gentium unlikely to get CHMP recommendation for defibrotide use in Hepatic Veno-Occlusive disease

Gentium S.p.A. had presented an oral explanation at the EMA Committee for Medicinal Products for Human Use ("CHMP") as part of its Marketing Authorization Application for Defibrotide to treat and prevent Hepatic Veno-Occlusive disease in adults and children undergoing hematopoietic stem cell transplantation therapy. Following the oral explanation,based on preliminary feedback from the CHMP,the Company expects an opinion recommending ...

Lyrica (Pfizer) as effective as Keppra (UCB) for Epilepsy treatment

Top-line results are reported by Pfizer for a Phase III study that showed Lyrica (pregabalin) Capsules CV were as effective as Keppra (levetiracetam) from UCB, as an adjunctive therapy in adult Epilepsy patients experiencing refractory partial onset seizures. The top-line results indicate that the study met its primary endpoint by demonstrating that a comparable proportion of patients on Lyrica achieved ...

Two trials demonstrate benefits of Pradaxa/Rendix (Boehringer) for patients with VTE

New findings from two double-blind, randomized trials, RE-MEDYSM and RE-SONATE, show that Pradaxa/Rendix (dabigatran etexilate), from Boehringer, reduces the risk of recurrent Venous ThromboEmbolism (VTE). RE-MEDY demonstrated that treatment with dabigatran 150 mg twice daily was non-inferior to warfarin (p=0.01) in preventing recurrent VTE, including VTE-related death. RE-SONATE demonstrated dabigatran was superior to placebo for the prevention of first recurrent ...

UCB files Cimzia at FDA and EMA for treatment of axial Spondyloarthritis

UCB announced two new regulatory filings with the FDA and with the European Medicines Agency (EMA) to extend the marketing authorization for Cimzia (certolizumab pegol) for the treatment of adult patients with active axial Spondyloarthritis (axSpA)

UCB files Cimzia for Psoriatic Arthritis at FDA and EMA

UCB announced two new regulatory filings with the FDA and with the European Medicines Agency to extend the marketing authorization for Cimzia (certolizumab pegol) for the treatment of adult patients with active Psoriatic Arthritis.

Sanofi files lixisenatide at FDA for treatment of Type 2 Diabetes

The FDA has accepted for review a New Drug Application (NDA) for lixisenatide from Sanofi, the first once-daily prandial GLP-1 receptor agonist for the treatment of adults with Type 2 Diabetes Mellitus. The acceptance of the lixisenatide NDA filing follows the February 1, 2013, European Commission approval of lixisenatide as Lyxumia, in the European Union.

The NDA submission ...

SOBI and Savient Pharma to co -promote Kineret in USA

Sobi and Savient Pharmaceuticals, Inc. have entered into an agreement for the co-promotion of Kineret (anakinra) in the U.S. Kineret, a recombinant IL-1 receptor antagonist, is a treatment for rheumatoid arthritis (RA) and indicated for the reduction in signs and symptoms and slowing the progression of structural damage in moderately to severely active RA in patients 18 years of ...

FDA approves Aorfix (Lombard Medical) for treatment of Abdominal Aortic Aneurysms

Lombard Medical Technologies PLC, the specialist medical technology company focused on innovative vascular products, announced on 15 February 2013 that Aorfix has been approved for commercial sale in the U.S. by the FDA.

Aorfix is a flexible stent graft for the endovascular repair of Abdominal Aortic Aneurysms ("AAAs"). Data from the U.S. PYTHAGORAS trial of Aorfix, has demonstrated that ...

St.Jude Medical initiates trial of EnligHTN system for CV Risk reduction

St. Jude Medical, Inc. has announced plans for a new landmark study that will evaluate whether renal denervation and medication can provide health benefits to patients beyond lowering high blood pressure. The EnligHTNment trial is the first large-scale study that will examine the long-term effects of the EnligHtN System of renal denervation in patients who have uncontrolled hypertension to see ...

EU approves Ilesto 7 (Biotronik) for patients with Heart Failure

The Ilesto 7 implantable cardioverter-defibrillator/cardiac resynchronization therapy defibrillator (ICD/CRT-D) series, from Biotronik, has received CE approval in the EU for patients with Heart Failure who require resynchronisation therapy. The Ilesto 7 series includes one of the world’s smallest ICDs and features ProMRI technology, which enables access to potentially life-saving MR scans. The Ilesto offers patients and physicians the greatest longevity ...

FDA approves Zortress (Novartis)for prophylaxis of organ rejection in Liver Transplant patients

Novartis announced that the FDA has, on 15 February 2013 ,approved Zortress (everolimus) for the prophylaxis of organ rejection in adult patients receiving a Liver Transplant.

Zortress is the first mammalian target of rapamycin (mTOR) inhibitor approved for use following Liver Transplantation. It is also the first immunosuppressant approved by the FDA in over a decade for use following ...

Positive data from Phase III study of Humira (AbbVie) in pediatric patients with Crohn's Disease

New data from the Phase III IMAgINE-1 trial of Humira (adalimumab), from AbbVie, shows that pediatric Crohn's Disease patients taking the drug experienced a significant improvement in select measures of health-related quality of life. The analyses assessed improvements in health-related quality of life (HRQOL) measures for pediatric patients aged 6 to 17 years with severe active Crohn's disease, taking Humira, ...

Study shows prebiotic Bimuno (Clasado) shows some benefits to Gastrointestinal health

A randomized, placebo-controlled study of the prebiotic Bimuno, from Clasado, shows evidence of benefit in patients at risk of reduced Gastrointestinal health. A total of 45 overweight adults (body mass index > 25 kg/m2) with at least 3 risk factors for Metabolic Syndrome were followed for 28 weeks. During the first 12 weeks, volunteers were randomly assigned to consume either ...

EU approves ApiFix AIS System (ApiFix) for Adolescent Idiopathic Scoliosis

ApiFix has received CE Mark approval for its ApiFix AIS correction system, a minimally invasive treatment system for Adolescent Idiopathic Scoliosis (AIS). ApiFix also reports that it has successfully completed a European pilot clinical trial with positive results.

In the ApiFix system, a small implant is attached to the center of the main spinal curvature using only two screws, resulting ...

FDA approves Argus II Retinal Prosthesis System for Retinitis Pigmentosa

The FDA on 14 February 2013 approved the Argus II Retinal Prosthesis System from Second Sight Medical Products Inc., the first implanted device to treat adult patients with advanced Retinitis Pigmentosa (RP). The device, which includes a small video camera, transmitter mounted on a pair of eyeglasses, video processing unit (VPU) and an implanted retinal prosthesis (artificial retina), replaces ...

FDA committee recommends approval of Dotarem (Guerbet SA) as MRI contrast agent

The Medical Imaging Drugs Advisory Committee to the FDA has voted unanimously to recommend approval of the New Drug Application (NDA) for Dotarem (gadoterate meglumine), from Guerbet SA, for adults, and for pediatric use for children two years of age and older in MRI Imaging. The Committee voted 10 to 6 (with one member abstaining) not to recommend at this ...

Phase III study shows TR 701 (Trius Therapeutics) equivalent to best alternative treatment for ABSSSI

New results from a Phase III study of TR 701 (tedizolid phosphate), from Trius Therapeutics, shows it is as effective as current best treatment for acute bacterial skin and skin structure infections(ABSSSI). The ESTABLISH 1 trial examined the efficacy and safety of 200 mg tedizolid given once a day for six days versus 600 mg linezolid given twice a day ...

Sanofi/Genzyme reports positive results from ENGAGE and ENCORE studies of eliglustat for Gaucher disease type 1

New data is reported from the Phase III ENGAGE and ENCORE studies of eliglustat tartrate from Genzyme/Sanofi, the investigational oral therapy for Gaucher disease type 1. The results from the ENGAGE study were presented at the 9th Annual Lysosomal Disease Network WORLD Symposium in Orlando, Fla. In conjunction with this meeting, Genzyme also released topline data from its second Phase ...

Treprostinil diolamine extended release tablets (United Therapeutics) re-filed at FDA for treatment of PAH

United Therapeutics Corporation has announced that the FDA has acknowledged the re-submission of the new drug application (NDA) for treprostinil diolamine extended release tablets (oral treprostinil) for the treatment of Pulmonary Arterial Hypertension. The FDA classified the re-submission as a complete, class 1 response to the FDA Complete Response Letter and set a user fee goal date of March 31, ...

Phase III trials of DSC 127 (Derma Sciences) start for Diabetic Foot Ulcers

Derma Sciences, Inc. has announced enrollment of patients has commenced in the first of two Phase III clinical trials with the Company’s investigational topical drug candidate DSC 127.

DSC 127 is an analog of a naturally occurring peptide, Angiotensin. It has been shown to increase keratinocyte proliferation, increase extracellular matrix production, and increase vascularization.

The two pivotal trials ...

Positive topline results from study of VXM01 (Vaximm) for Pancreatic Cancer

Topline data from a randomized, placebo-controlled, double-blind Phase I/II dose escalation study of vaccine VXM01, from Vaximm, shows the treatment met all key endpoints and demonstrated safety and tolerability in patients with Pancreatic Cancer. In this study (VXM01-01-DE), 45 patients with inoperable pancreatic cancer received several doses of VXM01 in addition to standard-of-care treatment, or placebo. Results indicate that the ...

Further results from TIVO-1 study of tivozanib (Aveo Oncology/ Astellas) for Renal Cell Carcinoma treatment

AVEO Oncology and Astellas have reported final overall survival (OS) results from the comparative Phase III TIVO-1 trial with tivozanib in the treatment of advanced Renal Cell Carcinoma (RCC). The protocol-specified analysis showed that the median OS of 28.8 months (95% CI: 22.5-NA) for the oral VEGF inhibitor was less than the 29.3 months (95% CI: 29.3-NA) for Nexavar ...

NICE does not recommend Jakavi (Novartis) for Myelofibrosis

NICE (National Institute for Health and Clinical Excellence) in its draft guidance stated that it is not recommending Jakavi (ruxolitinib) from Novartis, for the treatment of disease-related splenomegaly (enlarged spleen) or symptoms in adults with primary Myelofibrosis, or Myelofibrosis secondary to polycythaemia vera or essential Thrombocythaemia.

NICE stated that although the drug might offer a survival benefit, ...

PA 21( Galencia) is filed at FDA and EMA for treatment of Hyperphosphataemia in CKD patients

A New Drug Application (NDA) for PA21 from Fresenius Kabi/Galencia has been submitted to the FDA. Separately, the European Medicines Agency has accepted the Marketing Authorisation Application which was submitted December 2012 to seek approval in the European Union. Further submissions for approval are being prepared.

PA21 is a chewable, iron-based phosphate binder for the control of Hyperphosphatemia in ...

Study of Pycnogenol (Horpagh Research) shows benefits for Menopausal women

A new clinical trial has found that natural supplement Pycnogenol, from Horpagh Research Ltd, minimizes climacteric symptoms of menopausal women. A randomized, placebo-controlled, double-blind, parallel-group clinical trial was conducted and participants were given either placebo capsules or 30 mg of Pycnogenol twice per day, over a period of 12 weeks.

According to the study, the total symptom improvement using the ...

Bayer files riociguat for CTEPH and Pulmonary Arterial Hypertension at FDA and EU

Bayer HealthCare has submitted the oral investigational drug riociguat to treat patients with inoperable Chronic Thromboembolic Pulmonary Hypertension (CTEPH) and Pulmonary Arterial Hypertension (PAH) for regulatory approval in the United States and in the European Union. Riociguat was discovered by Bayer and represents the first member of a novel class of compounds, the stimulators of soluble guanylate cyclase. Riociguat ...

Avastin (Roche) success in Cervical Cancer trial

The National Institutes of Health (Gynaecological Oncology Group) revealed data showing that Avastin (bevacizumab) from Genentech/Roche, produced a median survival benefit of 17 months in the GOC 240 trial in patients with Cervical Cancer, compared to 13.3 months in the chemotherapy arm of the trial.

Roche provided the drug but was not involved in the trial itself. Full data ...

FDA issues Complete Response Letter to Novo Nordisk for Tresiba and Ryzodec

Novo Nordisk has announced that on 8 February 2013 it received a Complete Response Letter from the FDA regarding the New Drug Applications for Tresiba (insulin degludec) and Ryzodeg (insulin degludec/insulin aspart). A Complete Response Letter is issued by the FDA, when the agency determines that an application cannot be approved in its current form.

In the letter, the ...

Phase II study of AZD6244 (AstraZeneca) shows benefits for patients with Ovarian Cancer

A Phase II trial provides the first evidence that AZD6244 (selumetinib), from AstraZeneca, shows a relatively high response rate for patients with Ovarian Cancer. This clinical trial for low-grade serous Ovarian Cancer shows eight of 52 (15 percent) patients had a complete or objective partial response (tumor shrinkage) and 34 (65 percent) had no disease progression during the two-year study. ...

Successful studies for rFVIIIFc and rFIXFc (Biogen/Swedish Orphan) for Haemopilia

Biogen Idec and Swedish Orphan Biovitrum (Sobi)released data that confirmed the ability of investigational recombinant factors VIII Fc fusion protein (rFVIIIFc) and IX Fc fusion protein (rFIXFc) to provide long-lasting protection from bleeding with fewer injections than are required with the current standard of care for people with Haemophilia. The data, from the largest phase III registrational studies conducted ...

FDA approves Verity Extremity Scanner (Planmed) for X Ray Imaging

The FDA has issued 510(k) approval for the Planmed Verity Extremity Scanner. Planmed's Verity system is intended to be used for X Ray computed tomography of anatomies within upper and lower extremities. It utilizes CBCT (Cone Beam Computed Tomography) technology to provide high resolution volumetric 3D images of the extremities at a particularly low dose. Unlike any other 3D imaging ...

FDA grants accelerated approval to Pomalyst (Celgene) to treat Multiple Myeloma

The FDA on 8 February 2013, approved Pomalyst (pomalidomide), from Celgene, to treat patients with Multiple Myeloma whose disease progressed after being treated with other cancer drugs. Pomalyst is a pill that modulates the body’s immune system to destroy cancerous cells and inhibit their growth. It is intended for patients who have received at least two prior therapies, including ...

GSK files at EMA trametinib (monotherapy) and in combination with dabrafenib for Metastatic Melanoma

GSK announced submission of a Marketing Authorisation Application to the European Medicines Agency (EMA) for trametinib (MEK) as monotherapy and in combination with dabrafenib (BRAF) for the treatment of adult patients with unresectable or Metastatic Melanoma with a BRAF V600 mutation. The EMA’s Committee for Medicinal Products for Human Use (CHMP) has granted GSK’s request for accelerated assessment of ...

Success for Solitaire FR (Covidien) in STAR revasculization study

Covidien reports results from the two year Solitaire FR Thrombectomy for Acute Revasculization study(STAR study). The prospective, multi-center, single arm clinical study started with an enrollment of 202 patients at 14 centers across Europe, Australia and Canada in May 2010. In the study, patients diagnosed with Acute Ischaemic Stroke (AIS) (as confirmed by radiographic assessment) were treated with the ...

FDA approves Sculptor Robotic Guidance Arm (Stanmore Implants) for Surgery

Stanmore Implants has received 510(k) clearance from the FDA to market its Sculptor Robotic Guidance Arm for precision implant placement in unicompartmental knee Surgery, also known as partial knee resurfacing. The Sculptor RGA system is a robotic guide to assist with bone preparation, performed by a high speed cutting burr attached to the robotic arm, which limits the surgeon's operation ...

EU approves Lyxumia (Sanofi) to treat adults with Type 2 Diabetes

The EU has granted a marketing authorisation in Europe for Lyxumia (lixisenatide), from Sanofi, for the treatment of Type 2 Diabetes in adults. The decision is based on results from Sanofi’s international GetGoal Phase III program, involving more than 5,000 patients with Type 2 Diabetes in 11 clinical studies.

The results showed that treatment with Lyxumia gave significant HbA1c ...

FISSION and Neutrino studies success for GS 7977 (Gilead Sciences) for Hepatitis C

Gilead Sciences has announced topline results from two Phase III studies, FISSION and NEUTRINO, evaluating a 12-week course of the once-daily nucleotide sofosbuvir in combination with ribavirin (FISSION) and in combination with ribavirin and pegylated interferon (NEUTRINO) among treatment-naïve patients with chronic Hepatitis C virus (HCV) infection.

In the FISSION study, patients with genotype 2 or 3 HCV ...

NICE does not recommend Krystexxa (Savient Pharma) for treatment of severe Gout

The National Institute for Health and Clinical Excellence (NICE) has opened a consultation on the use of Krystexxa (peglioticase) from Savient Pharma, in treating severe debilitating chronic tophaceous Gout in adults. Draft guidance does not recommend the drug for this use. NICE's independent appraisal committee has decided that the drug effectively lowers the level of uric acid in the ...

Soluble Ferric Pyrophosphate (Rockwell Medical) success in Phase III trial for Iron Deficiency

Rockwell Medical announced successful topline results from the PRIME clinical study of Soluble Ferric Pyrophosphate (SFP), its investigational iron-delivery drug currently in Phase III clinical studies for the treatment of Iron Deficiency in hemodialysis patients. The PRIME study demonstrated that regular administration of SFP-iron via dialysate reduced the usage of erythropoietin stimulating agents (ESAs) during hemodialysis by 37.1% while ...

FDA approves Ravicti (Hyperion Therapeutics ) for Urea Cycle Disorders

On 31 January the FDA approved Ravicti (glycerol phenylbutyrate) from Hyperion Therapeutics, for the chronic management of some Urea Cycle Disorders in patients ages 2 years and older.

Urea Cycle Disorders, or UCDs, are a collection of inherited metabolic disorders in which affected patients suffer from high levels of systemic ammonia, a potent neurotoxin. Ammonia is produced via ...

GSK initiates Phase III study of combination dabrafenib and trametinib for Melanoma

GlaxoSmithKline plc. announced the start of COMBI-AD, a Phase III study evaluating the combination of dabrafenib, its BRAF inhibitor and trametinib, its MEK inhibitor as adjuvant therapy for Melanoma. This global study will investigate whether combining the two investigational agents can delay or prevent the recurrence of melanoma (Relapse Free Survival) in patients with Stage IIIa, IIIb, or IIIc ...

New meta-analysis shows benefits of Xiaflex (Auxilium Pharmaceuticals) for Peyronie's disease

A meta-analysis of Phase III results assessing Xiaflex (clostridial collangase for injection), from Auxilium Pharmaceuticals, for the treatment of Peyronie's disease provides new results on previous IMPRESS studies' co-primary and secondary endpoints. Post-hoc meta-analysis from a combination of identical IMPRESS I and II studies indicates that the co-primary endpoints maintain statistical significance. In addition, the % of global responders, the ...

NICE rejects Forxiga (BMS/AstraZeneca) as a treatment for Type 2 Diabetes

In a draft guidance published 1 February 2013, The National Institute of Health and Clinical Excellence (NICE) is minded not to recommend Forxiga (dapagliflozin) from BMS and Astra Zeneca, in combination therapy for treating Type 2 Diabetes. NICE is requesting further clarification and information from the manufacturers ahead of the second Appraisal Committee meeting in March 2013.

Study of Qsymia (Vivus inc.) shows positive benefits for treatment of Obesity

A new study concludes that weight loss resulting from treatment with Qsymia (phentermine and topiramate extended-release), from Vivus inc., led to significant improvements in cholesterol, blood pressure and triglycerides in Obese and overweight patients. The improvements were significantly greater among patients who lost 10% or more of their starting weight. Participants in the study with body mass indexes of 27 ...

Bronchitol (Pharmaxis) is rejected by FDA Advisory Committee as a treatment for Cystic Fibrosis

Pharmaxis has received a negative recommendation from the Pulmonary-Allergy Drugs Advisory Committee (PADAC) advising the FDA on the use of Bronchitol (inhaled dry powder mannitol) for Cystic Fibrosis patients in the United States.

The PADAC voted on three questions relating to Bronchitol’s safety and efficacy in Cystic Fibrosis patients aged 6 years and over, with a negative result on ...

EU approves Optisharp (DSM Nutritional Products) for nutritional use

The European Commission approved the use of nature-identical Optisharp (zeaxanthin), from DSM Nutritional Products, as an ingredient in food supplements as a way to improve visual performance. The decision follows a positive EFSA safety assessment delivered on September 13, 2012, which concluded that the use level for zeaxanthin does not raise safety concerns. Studies have suggested that high concentration of ...

Tavaborole (Anacor Pharma) success in Phase III for Onychomycosis

Anacor Pharmaceuticals has announced positive preliminary results from the first of two Phase III trials of tavaborole, its topical anti-fungal for Onychomycosis, a fungal infection of the nail and nail bed that affects approximately 35 million people in the United States. Tavaborole achieved a high degree of statistical significance on all primary and secondary endpoints.

In this first Phase ...

Obinutuzumab (Genentech) success in Phase III trial for CLL

Genentech has announced positive results from Stage 1 of CLL11, a Phase III randomized study to investigate the efficacy and safety profile of the investigational medicine obinutuzumab (GA101) plus chlorambucil chemotherapy compared with chlorambucil alone in people with previously untreated Chronic Lymphocytic Leukemia (CLL). An improvement in progression-free survival (PFS) was achieved as GA101 plus chlorambucil significantly reduced the risk ...

Phase II study of Monarch eTNS (NeuroSigma) shows benefits for Epilepsy

New results from a Phase II clinical study for the use of Monarch external Trigeminal Nerve Stimulation (eTNS), from NeuroSigma, for the treatment of drug-resistant Epilepsy demonstrated that among patients receiving eTNS there were significant reductions in seizure frequency over the course of the 18-week study. Patients receiving eTNS also demonstrated significant improvements in mood, making eTNS unique among ...

StJude Medical expands scope of EnligHtN RDS system in uncontrolled Hypertension with EnligHTN II trial

St. Jude Medical, Inc. has announced enrollment of the first patient in the EnligHTN II trial. This post-market clinical study will further evaluate the safety and efficacy of the EnligHTN Renal Denervation System in patients with uncontrolled hypertension.The EnligHTN II study aims to broaden this scope by evaluating the mean reduction in systolic blood pressure at six months across all ...

Tasimelteon (Vanda) fails trial for treatment of Depression.

Vanda Pharmaceuticals Inc. has announced top-line results of the Phase IIb/III clinical study (MAGELLAN) in Major Depressive Disorder (MDD), investigating the efficacy and safety of tasimelteon as a monotherapy in the treatment of patients with MDD. The clinical study did not meet the primary endpoint of change from baseline in the Hamilton Depression Scale (HAMD-17) after 8 weeks of treatment ...

ThermoDox (Celsion) fails Phase III trial for Liver Cancer

Celsion Corporation has announced that ThermoDox in combination with radiofrequency ablation (RFA) did not meet the primary endpoint of the Phase III HEAT Study in patients with Hepatocellular Carcinoma (HCC), also known as Primary Liver Cancer. Specifically, Celsion has determined, after conferring with its independent Data Monitoring Committee (DMC) that the HEAT Study did not meet the goal of demonstrating ...

FDA approves Kynamro (Genzyme/Sanofi) to treat Homozygous Familial Hypercholesterolemia

The FDA 0n 29 January 2013 approved Kynamro (mipomersen sodium) injection, from Genzyme/Sanofi, as an addition to lipid-lowering medications and diet to treat patients with a rare type of high cholesterol called Homozygous Familial Hypercholesterolemia (HoFH). The addition of Kynamro helps to reduce low-density lipoprotein-cholesterol (LDL-C), apolipoprotein B, total cholesterol, and non-high density lipoprotein-cholesterol (non HDL-C).

HoFH, an ...

FDA recommends approval of BI 1744-CL (Boehringer) for COPD

The FDA's Pulmonary-Allergy Drugs Advisory Committee (PADAC) recommended supporting the approval of BI 1744-CL (olodaterol), from Boehringer, as a once-daily maintenance bronchodilator treatment for airflow obstruction in patients with Chronic Obstructive Pulmonary Disease (COPD), including chronic Bronchitis and/or emphysema. If approved by the FDA, it is anticipated that olodaterol will be marketed under the brand name Striverdi Respimat in the ...

Latanoprostene bunod (Bausch & Lomb) enters Phase III for Glaucoma and Ocular Hypertension

Bausch + Lomb, have announced that Bausch + Lomb has initiated its Phase III clinical program of latanoprostene bunod (previously known as BOL-303259-X and NCX 116) for the reduction of intraocular pressure (IOP) in patients with Glaucoma or Ocular Hypertension. Latanoprostene bunod is a nitric oxide-donating prostaglandin F2 alpha analog licensed by Nicox to Bausch + Lomb.

This pivotal Phase ...

Positive results from Phase III trial of Avastin (Genentech/Roche) in elderly Colorectal Cancer patients

The results of the Phase III AVEX trial show that Avastin (bevacizumab), from Genentech/Roche, in combination with Xeloda (capecitabine) can significantly extend the time people aged over 70 live without their previously untreated advanced Bowel Cancer worsening - by 4 months - compared to Xeloda alone (median progression free survival of 9.1 months compared to 5.1 months respectively, HR =0 ...

Positive results in study of Metanx (PamLab) for Diabetic Peripheral Neuropathy

A new multicenter study suggests that nutritional management of Diabetic Peripheral Neuropathy (DPN) with Metanx, (L-methylfolate, methylcobalamin, and pyridoxal 5'-phosphate), from PamLab, improves total symptoms and health-related quality of life. Two hundred fourteen patients with Type 2 DPN were randomized to receive either Metanx or identical placebo for 6 months. The Neuropathy Disability Score with Metanx demonstrated greater improvement than ...

Zerenex (Keryc Biophrama) succuss in Phase III trial for Hyperphosphatemia

Keryx Biopharmaceuticals, Inc.announced successful top-line results from the long-term Phase III study of Zerenex (ferric citrate), the Company's ferric iron-based phosphate binder drug candidate, for the treatment of elevated serum phosphorus levels, or Hyperphosphatemia, in patients with end-stage renal disease (ESRD) on dialysis. In this study, Zerenex met the study's primary endpoint, described below, demonstrating a highly statistically significant change ...

Sanofi/Genzyme files Lemtrada at FDA for treatment of Multiple Sclerosis

Sanofi and its subsidiary Genzyme announced that the FDA has accepted for review the company’s supplemental Biologics License Application file seeking approval of Lemtrada (alemtuzumab) for the treatment of relapsing Multiple Sclerosis.

Genzyme expects FDA action on the application in the second half of 2013. Genzyme has already submitted its marketing authorization application for Lemtrada to the European Medicines Agency ...

Phase III study of Neulasta (Amgen) for Neutropenia in Colorectal Cancer meets primary endpoint

PAVES, a Phase III trial evaluating Neulasta (pegfilgrastim), from Amgen, in 845 patients receiving FOLFOX or FOLFIRI and bevacizumab for first-line treatment of metastatic Colorectal Cancer, has met its primary endpoint, with Neulasta significantly reducing the incidence of febrile Neutropenia. All patients received treatment with either FOLFOX or FOLFIRI plus bevacizumab and were randomized to receive either placebo or 6 ...

FDA approves extension of Prevnar 13 vaccine indication

Pfizer Inc. has announced that the FDA has granted approval on 25 January 2013 for the expansion of the company’s pneumococcal conjugate vaccine, Prevnar 13 (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]), for use in older children and adolescents aged 6 years through 17 years for active immunization for the prevention of invasive disease caused by the 13 Streptococcus ...

FDA approves Gleevec (Novartis) to treat Ph+ALL

The FDA on 25 January 2013 approved a new use of Gleevec (imatinib) to treat children newly diagnosed with Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia (ALL). ALL is the most common type of pediatric cancer, affecting approximately 2,900 children annually, and progresses quickly if untreated. Children with Ph+ ALL have a genetic abnormality that causes proteins called tyrosine kinases ...

FDA approves Nesina,Oseni and Kazano (Takeda) treatments for Type 2 Diabetes

Takeda Pharmaceutical Company Limited (Takeda) and its wholly-owned subsidiary, Takeda Pharmaceuticals U.S.A., Inc. announced that the FDA has approved Nesina (alogliptin) and the fixed-dose combination (FDC) therapies Oseni (alogliptin and pioglitazone) and Kazano(alogliptin and metformin HCl) for the treatment of Type 2 Diabetes in adults as adjuncts to diet and exercise.

Nesina is a dipeptidyl peptidase-4 inhibitor ...

FDA approves Edge Radiosurgery Suite (Varian Medical Systems) for Radiation Therapy

The FDA has given 510(k) clearance for Varian Medical System's Edge Radiosurgery Suite, a new dedicated system for performing advanced Radiation Therapy using new real-time tumor tracking and motion management technologies. The system includes an integrated six degrees of freedom couch that provides the accuracy, precision, and flexibility needed to position patients. It also allows expanded use of fluoroscopy and ...

FDA approves Focused Cold Therapy (myoscience) for patients with Peripheral Nerve Pain

The FDA has approved Focused Cold Therapy, from myoscience, for the treatment of Peripheral Nerve Pain. Focused Cold Therapy relies upon the science of cryoneuromodulation to precisely deliver cold to peripheral nerve tissue. It uses a device that resembles a magic marker pen, but which uses small needles to inject cryogenic material directly into the skin where it disrupts nerve ...

NICE now recommends Colobreathe (Forest Labs)for Cystic Fibrosis infections.

NICE now recommends Colobreathe(colistimethate dry powder for inhalation) from Forest Labs as an option for treating chronic pulmonary infection caused by Pseudomonas aeruginosa in people with Cystic Fibrosis.

Colobreathe is recommended for those patients who would clinically benefit from continued Colobreathe treatment, but do not tolerate it in its nebulised form and the positive recommendation is subject to ...

Novartis withdraws application at EMA for Ruvise treatment for PAH

The European Medicines Agency has been formally notified by Novartis Europharm Ltd of its decision to withdraw its application for a centralised marketing authorisation for the medicine Ruvise (imatinib mesilate), 100- and 400-mg film-coated tablets. It was intended to be used for adults as add-on therapy for the treatment of Pulmonary Arterial Hypertension.

The company stated that it is ...

Positive results in Phase III trial of Xeljanz (Pfizer) in patients with Rheumatoid Arthritis

A Phase III clinical trial demonstrates that Xeljanz (tofacitinib), from Pfizer, improves disease activity and inhibits progression of joint damage in Rheumatoid Arthritis (RA) patients who did not respond to methotrexate (MTX). In this 24-month, double-blind, placebo-controlled study, 797 participants were randomized to receive 5mg of tofacitinib (n=321); 10 mg of tofacitinib (n=316) or placebo. Results from a 12-month interim ...

Results of REDUCE study show benefits from Avodart/Avolve (Glaxo Smith Kline) for Prostate Cancer Risk

New results from the four-year REDUCE clinical study evaluating Prostate Cancer Risk reduction in men taking Avodart/Avolve (dutasteride), from Glaxo Smith Kline, have been announced. REDUCE results showed that dutasteride decreased the risk of biopsy detectable Prostate Cancer by 22.8 percent compared to a placebo group, but concerns remained about the drug’s effectiveness. Nearly 2,800 men from the REDUCE study ...

Soliris (Alexion Pharma) rejected by UK Health Ministers for Haemolytic Uraemic Syndrome

Soliris (eculizumab)from Alexion Pharma was referred in the UK to the Advisory Group for National Specialised Services (AGNSS) instead of NICE and AGNSS recommended the $400 000 per patient, per year, drug for treatment of patients with atypical Haemolytic Uraemic Syndrome (aHUS), a rare, chronic blood disease. The decision of AGNSS was overruled by Health Ministers and the application has ...

FDA approves Exjade (Novartis) to treat Non-Transfusion-Dependent Thalassemia

The FDA on 23 January 2013 expanded the approved use of Exjade (deferasirox) from Novartis, to treat patients ages 10 years and older who have chronic iron overload resulting from a genetic blood disorder called Non-Transfusion-Dependent Thalassemia (NTDT).

NTDT is a milder form of thalassemia that does not require individuals to get frequent red blood cell transfusions. However, over ...

Peginterferon beta-1a (Biogen) success in ADVANCE study for MS

Biogen Idec released the primary efficacy analysis and safety data from its Phase III pivotal clinical trial, ADVANCE. Results support peginterferon beta-1a as a potential treatment dosed every two weeks or every four weeks for relapsing-remitting Multiple Sclerosis (RRMS). Peginterferon beta-1a is a new molecular entity in which interferon beta-1a is pegylated to extend its half-life and prolong its ...

Abraxane(Celgene) success in MPACT trial for combination treatment of Pancreatic Cancer

Celgene International Sàrl,has announced that its phase III clinical trial of Abraxane (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) in combination with gemcitabine in treatment-naïve patients with metastatic Pancreatic Cancer demonstrated a statistically significant improvement in overall survival compared to patients receiving gemcitabine alone [(median of 8.5 vs. 6.7 months) (HR 0.72, P=0.000015)].

In the MPACT (Metastatic Pancreatic Adenocarcinoma Clinical ...

FDA issues Complete Response Letter regarding Rytary (Impax Pharma) for Parkinsons disease

Impax Pharmaceuticals, a division of Impax Laboratories, Inc. has announced that the FDA has issued a Complete Response Letter regarding the New Drug Application (NDA) for Rytary (IPX066), an extended-release capsule formulation of carbidopa-levodopa, a potential treatment for the symptomatic treatment of Parkinson's disease currently under review in the United States.

The Complete Response Letter indicates that the FDA ...

NICE recommends Eliquis (Pfizer/BMS) for Stroke Prevention

NICE (The National Institute of Health and Clinical Excellence) has recommended the oral anticoagulant Eliquis (apixaban) from BMS and Pfizer, as an option for Prevention of Sroke and Systemic Embolism in people with non-valvular Atrial Fibrillation with one or more risk factors.

The NICE appraisal committee considered that Eliquis was cost effective and more clinically effective for reducing stroke and ...

Positive results from study of Symphony tCGM System (Echo Therapeutics) in critically ill patients

New results of needle-free Symphony Transdermal Continuous Glucose Monitoring (tCGM) System, from Echo Therapeutics, a non-invasive, wireless, transdermal continuous glucose monitoring system, collected from a clinical study of 15 critically ill patients over a 24 hour period at Tufts Medical Center in Boston, have been presented. Results show that using 570 Symphony tCGM glucose readings, paired with reference blood glucose ...

CHMP recommends extension of indication of Humira(AbbVie) in JIA

The CHMP recommends that Humira (adalimumab) from AbbVie, in combination with methotrexate is to be indicated for the treatment of active Polyarticular Juvenile Idiopathic Arthritis, in children and adolescents aged 2 to 17 years who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs). Humira can be given as monotherapy in case of intolerance to ...

CHMP recommends Pegasys(Roche) for paediatric use in Hepatitis C

The CHMP recommends Pegasys (peginterferon alfa-2a) from Roche, in combination with ribavirin, be indicated for the treatment of chronic Hepatitis C in treatment-naïve children and adolescents five years of age and older, who are positive for serum hepatitis-C-virus (HCV) RNA. When deciding to initiate treatment in childhood, it is important to consider growth inhibition induced by combination therapy. The ...

EU approves Tresiba and Ryzodeg (Novo Nordisk) for Diabetes

Novo Nordisk has announced that the European Commission on 21 January 2013, has granted marketing authorisations for Tresiba (insulin degludec) and Ryzodeg (insulin degludec/insulin aspart) for the treatment of Diabetes in adults. The authorisations cover all 27 European Union member states.

Tresiba, the brand name for insulin degludec, is a once-daily new-generation basal insulin analogue with an ultra-long duration ...

European Commission approves Bexsero vaccine (Novartis) for Meningococcal Disease

Novartis has announced that the European Commission has approved Bexsero (Meningococcal Group B Vaccine [rDNA, component, adsorbed]) for use in individuals from 2 months of age and older. Novartis is committed to making Bexsero available as soon as possible.

MenB disease is a bacterial infection and is the leading cause of meningitis across Europe, particularly in infants. Although ...

CE Mark granted to st Jude Medical for Amplatzer LAA Occluder

European CE Mark approval is granted to St. Jude Medical for its Amplatzer Amulet Left Atrial Appendage Occluder. The Amulet device is used to close the left atrial appendage (LAA) in patients diagnosed with non-valvular atrial fibrillation (AF). According to research, AF leads to an increased risk for stroke. Sealing off the LAA helps prevent the risk of blood clot ...

EC approve new strength Prezista (J&J Janssen Cilag) for AIDS patients

The European Commission has approved a new Prezista (darunavir) 800mg tablet, from J&J Janssen Cilag, allowing people living with HIV to take one darunavir tablet once a day. Darunavir is indicated in combination with other antiretrovirals for the treatment of HIV-1 infection in treatment-experienced and treatment-naive patients with no darunavir resistance-associated mutations. This new tablet strength has been developed to ...

FDA approves Botox (Allergan) as a treatment for Overactive Bladder

The FDA on 18 January 2013 expanded the approved use of Botox (onabotulinumtoxinA) from Allergan, to treat adults with Overactive Bladder who cannot use or do not adequately respond to a class of medications known as anticholinergics.

When Botox is injected into the bladder muscle, it causes the bladder to relax, increasing the bladder’s storage capacity and reducing ...

GI Dynamics initiates ENDO trial for treatment of Type 2 Diabetes and Obesity

GI Dynamics has initiated its U.S. multicenter pivotal clinical trial of EndoBarrier, the ENDO Trial, for the treatment of patients who have uncontrolled Type 2 Diabetes and are Obese.

EndoBarrier is a thin, flexible, tube-shaped liner that forms a physical barrier between food and a portion of the wall of the intestine. In previous clinical studies, EndoBarrier has ...

CHMP recommends bosutinib (Pfizer) for PH+CML

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion regarding the conditional marketing authorization of bosutinib from Pfizer, in the European Union (EU), for the treatment of adult patients with chronic phase (CP), accelerated phase (AP), and blast phase (BP) Philadelphia chromosome positive Chronic Myelogenous Leukemia (Ph+ CML) ...

CHMP recommends Ilaris (Novartis) for treatment of Acute Gouty Arthritis

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for the use of llaris (canakinumab, ACZ885) from Novartis, in the treatment of patients with acute Gouty Arthritis who suffer frequent attacks, and whose symptoms cannot or should not be managed with current treatment options.

Ilaris is the only available ...

CHMP recommends Jetrea (Alcon)for treatment of Vitreomacular Traction.

Alcon, the eye care division of Novartis, announces the positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for Jetrea (ocriplasmin), for the treatment of Vitreomacular Traction (VMT), including when associated with macular hole of diameter less than or equal to 400 microns. VMT is an age-related progressive condition that ...

Cinryze(ViroPharma) success in paediatric Hereditary Angio-Oedema

New data demonstrates that use of Cinryze (C1 esterase inhibitor [human]), from Viro Pharma, in pediatric patients provided relief from symptoms of Hereditary Angio-Oedema (HAO) attacks and reduced the rate of attacks. In the study, children had a nearly twofold reduction in number of HAE attacks while receiving Cinryze for prophylaxis compared with the time period during which they received ...

EMA rejects Raxone/Catena (Santhera) as a treatment for Leber's Hereditary Optic Neuropathy

Santhera Pharmaceuticals has announced that it has received a negative opinion on its Marketing Authorization Application (MAA) for Raxone (idebenone) as a potential therapy for Leber's Hereditary Optic Neuropathy (LHON). The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has notified Santhera that a narrow majority of CHMP members deemed Raxone not approvable at this time. Santhera ...

FDA approves octaplas LG (Octapharma) coagulation factor

The FDA has on 18 January 2013, approved octaplas,from Octapharma, a pooled plasma (human) blood product for the replacement of clotting proteins (coagulation factors) in certain medical conditions where patients have insufficient levels. Clotting protein deficiencies can cause excessive bleeding or excessive clotting.

Octaplas has been used extensively in Europe and other countries. A previous generation of octaplas was ...

FDA approves the iASSIST Knee (Zimmer) for Knee Replacement surgery

The FDA has given 510(k) clearance to the iASSIST Knee, from Zimmer, which is a personalized guidance system for Knee Replacement procedures. The technology comprises small electronic disposable pod components that are used at the site of knee replacement surgery, providing instantaneous, accurate alignment validation through a simple electronic display.

The disposable pods are manipulated within the surgical field with ...

FDA approves Zecuity (NuPathe) Migraine patch

NuPathe Inc.has announced that the FDA has approved Zecuity (sumatriptan iontophoretic transdermal system) for the acute treatment of Migraine with or without aura in adults. Zecuity is a single-use, battery-powered patch that actively delivers sumatriptan, the most widely prescribed migraine medication, through the skin. Zecuity provides relief of both migraine headache pain and migraine-related nausea (MRN). Zecuity is the first ...

Preliminary results from Phase IIb study of BI 201335 and BI 207127 (Boehringer) show positive response in Hepatitis C patients

New preliminary results from the SOUND-C3 trial, Boehringer Ingelheim's investigational Interferon-free regimen which combines BI 201335 (faldaprevir) and BI 207127, show that 100 percent (n=20) of patients with Hepatitis C GT-1b achieved sustained virologic response four weeks (SVR4) after completing a 16 week course of treatment. Two patients experienced serious adverse events and two patients discontinued treatment early due to ...

Aranesp (Amgen) fails Heart Failure trial

Amgen announced top-line results of the Phase III Aranesp (darbepoetin alfa) RED-HF (Reduction of Events With Darbepoetin Alfa in Heart Failure) Trial. The trial was initiated in 2006, and a total of 2,278 patients with symptomatic systolic heart failure and anemia (hemoglobin levels ranging from 9.0-12.0 g/dL) were randomized to receive either treatment with Aranesp to achieve a target ...

European Commission approves Amyvid (li Lilly) for Alzheimers disease investigations

Eli Lilly and Company and Avid Radiopharmaceuticals, Inc., a wholly owned subsidiary of Lilly, announced that Amyvid (Florbetapir F 18 Injection) has received marketing authorization from the European Commission as a diagnostic radiopharmaceutical indicated for Positron Emission Tomography (PET) imaging of beta-amyloid neuritic plaque density in the brains of adult patients with cognitive impairment who are being evaluated for Alzheimer's ...

FDA approves FluBlok vaccine ( Protein Sciences) for Influenza

The FDA announced on 16 January 2013 that it has approved Flublok, the first trivalent influenza vaccine made using an insect virus (baculovirus) expression system and recombinant DNA technology. Flublok is approved for the prevention of seasonal influenza in people 18 through 49 years of age. As it does with all influenza vaccines, the FDA will evaluate Flublok annually prior ...

Biogen/Elan file Tysabri at FDA and EMA for first line treatment of Multiple Sclerosis

Biogen Idec and Elan Corporation have announced that they have submitted applications to the FDA and European Medicines Agency requesting updates to the Tysabri (natalizumab) labels for treatment of Multiple Sclerosis. The applications request an expanded indication that would include first-line use for people living with certain relapsing forms of Multiple Sclerosis who have tested negative for antibodies to the ...

EU approves APPY1 test (Venaxis) for patients at low risk for acute Appendicitis

The EU has given CE Mark approval to the APPY1 blood-based Appendicitis test, from Venaxis. The unique test is designed to aid in the identification of patients at low risk for acute Appendicitis, allowing for more conservative patient management. APPY1 is being developed initially for pediatric, adolescent and young adult patients with abdominal pain, as this population is at the ...

NICE draft guidance recommends therapies for Prevention of Breast Cancer

NICE (The National Institute of Health and Clinical Excellence) has produced draft guidance on familial Breast Cancer, proposing the use, over five years, of hormonal therapies, tamoxifen or Evista (raloxifene), by post menopausal women at a high risk of Breast Cancer. Both drugs reduce the risk but they do come with side effects, and these carry a different weight when ...

Study shows Anti-VEGF treatments could cause harmful side-effects in the eye

A new study reveals that increasingly aggressive therapies that block VEGF, such as VEGF TRAP-EYE, from Bayer HealthCare, could cause damage in treating eye diseases. Scientists discovered inhibiting anti-VEGF might have a harmful effect on the tissue responsible for producing the fluid that bathes the eye, medically termed the ciliary body. Investigators simulated the VEGF-A activity in adult mice and ...

FDA approves Uceris (Santarus) for mild to moderate Ulcerative Colitis

The FDA has approved Uceris (budesonide) extended release tablets, from Santarus, for the induction of remission in patients with active, mild to moderate Ulcerative Colitis. Approval is based on two trials, namely study CB 01-02/02 in Europe and CB 01-02/01 in USA and India, which showed the drug superior to placebo in achieving clinical remission as measured by the Ulcerative ...

European Commission extends Zytiga(Janssen Cilag) indication in Prostate Cancer

Janssen-Cilag has announced that the European Commission has approved an extension to the licence of Zytiga (abiraterone acetate), to include its use in combination with prednisone or prednisolone, for the treatment of metastatic castration-resistant Prostate Cancer (mCRPC) in men who have failed on androgen deprivation therapy in whom chemotherapy is not yet indicated. The oral, once-daily drug, with prednisone ...

GSK files albiglutide at FDA for treatment of Type 2 Diabetes

GlaxoSmithKline (GSK) plc has announced a regulatory submission to the FDA for albiglutide, an investigational once-weekly treatment for adult patients with Type 2 Diabetes. Albiglutide is not yet approved as a treatment for Type 2 Diabetes or any other indication anywhere in the world.

Albiglutide, a GLP-1 receptor agonist, is an investigational biological product for the treatment of ...

The Lancet reports successful Phase III study of Bexsero vaccine (Novartis)against MenB

The Lancet published findings online from a pivotal Phase III clinical trial of Bexsero (Meningococcal Group B Vaccine [rDNA, component, adsorbed]) from Novartis, involving 3,630 infants from two months of age. The study showed that Bexsero demonstrated a protective immune response and has an acceptable safety profile when administered as a three-dose primary series concomitantly with routine vaccines. The investigators ...

EU approves Betmiga (Astellas) for the treatment of Overactive Bladder

Betmiga (mirabegron), from Astellas, has received approval from the European Commission for the treatment of Overactive Bladder (OAB) symptoms in adults. The European Commission granted approval of mirabegron following the recommendation by the CHMP in October 2012. They reviewed extensive clinical trial evidence from 7 Phase II / III studies in which over 5,000 patients received mirabegron, including 3 Phase ...

Dalbavancin (Durata Therapeutics) reports on DISCOVER 1 trial for Skin Infections

Durata Therapeutics has announced additional preliminary, top-line results for its DISCOVER 1 ("Dalbavancin for Infections of the Skin COmpared to Vancomycin at an Early Response") Phase III study of dalbavancin, which is under investigation for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible gram-positive bacteria, including MRSA (methicillin resistant Staphylococcus aureus).

As ...

FDA Advisory Committee recommends Invokana (canagliflozin ) from Janssen Pharma as a treatment for Type 2 Diabetes

The FDA Endocrinologic and Metabolic Drugs Advisory Committee voted 10-5 to recommend approval for canagliflozin from Janssen Pharmaceuticals with the proposed trade name Invokana, to treat Type 2 Diabetes in adult patients based on the efficacy and safety results from its comprehensive clinical development program.

The committee also voted 8 to 7 that they had concerns about potential ...

Merck Inc,. withdraws Tredaptive treatment for Dyslipidaemia

Merck Inc.,announced that it is taking steps to suspend the availability of Tredaptive (extended-release niacin/laropiprant) tablets worldwide. Tredaptive is not approved for use in the United States.

Merck is taking these steps based on the current understanding of the preliminary data from the HPS2-THRIVE (Heart Protection Study 2-Treatment of HDL to Reduce the Incidence of Vascular Events) study, ...

Phase III trial of MORAb 003 (Morphotek/Eisai) for Ovarian Cancer fails to meet primary endpoint

Top-line results from a Phase III study of MORAb 003 (farletuzumab), from Morphotek/Eisai, in combination with carboplatin and a taxane in patients with platinum-sensitive epithelial Ovarian Cancer in first relapse did not meet the study's primary endpoint of progression-free survival (PFS). In the double-blind, placebo-controlled FAR 131 study, 1,100 patients were enrolled to receive standard-of-care (carboplatin and a taxane [paclitaxel ...

Votubia/Afinitor success in treatment of Renal Angiomyolipoma reported in The Lancet

Data published in The Lancet showed that patients on Afinitor (everolimus) tablets from Novartis, with non-cancerous kidney tumors known as Renal Angiomyolipomas associated with Tuberous Sclerosis Complex (TSC) experienced a significant reduction in tumor size and the absence of tumor progression. Additionally, a recent issue of The Lancet featured results from a separate everolimus trial demonstrating a reduction in ...

3-D X-ray mammography using Hologics Inc system improves diagnosis of Breast Cancer

A new study found that the addition of three dimensional (3D) mammography (breast tomosynthesis) screening technology, from Hologic inc, to a 2D breast screening exam significantly increased Breast Cancer detection while reducing the number of false positives. The researchers using Hologic's 3D mammography technology in combination with a 2D mammogram found a significant increase in cancer detection rates, particularly for ...

Cangrelor(The Medicines Company) success in Phase III trial for PCI

The Medicines Company has announced results for its pivotal Phase III clinical trial of cangrelor, which is in development to prevent platelet activation and aggregation that leads to thrombosis in the acute care setting, including in patients undergoing percutaneous coronary intervention (PCI). Following the recommendation of the trial's Data Safety Monitoring Board (DSMB) in July 2012 to continue the protocol ...

FDA approves Skyla (Bayer)levonorgestrel-releasing intrauterine system for use as a Contraceptive

The FDA has approved a new low-dose hormone intrauterine device designed to prevent pregnancy, the first new device of its type in 12 years, according to Bayer AG.

The T-shaped polyethylene device, known as Skyla, is designed to prevent pregnancy for 3 years, during which time it releases a diminishing dosage of progestin. The proportion of women using long-acting reversible ...

FEIBA NF success in Phase III trial for Hemophilia A and B

Baxter International Inc. has announced pivotal Phase III study results evaluating the efficacy and safety of routine prophylaxis compared to on-demand treatment of FEIBA NF [Anti-Inhibitor Coagulant Complex], Nanofiltered and Vapor Heated, in patients with Hemophilia A or B and inhibitors

Top-line results from the study showed a reduced median annual bleed rate (ABR) from 28.7 during FEIBA NF ...

GSK/Theravance file GSK 573719 plus vilanterol at the EMA for COPD

GlaxoSmithKline and Theravance have announced the submission of a regulatory application to the EMA for the investigational once-daily LAMA/LABA combination medicine, UMEC/VI, for patients with Chronic Obstructive Pulmonary Disease (COPD).

UMEC/VI is a combination of two investigational bronchodilator molecules -- GSK 573719 or umeclidinium bromide (UMEC), a long-acting muscarinic antagonist and vilanterol (VI), a long-acting beta2 agonist ,administered using ...

FDA approves acetylcysteine injection (APP Pharma) generic version of Acetadote

The FDA has given approval for the Abbreviated New Drug Application (ANDA) for acetylcysteine injection, from APP Pharma, indicated to prevent or lessen hepatic injury following an acetaminophen overdose. Acetylcysteine injection will be available as a 20% solution (200mg/mL) in 30mL single-dose glass vials. Acetylcysteine injection is sterile and can be used for I.V. administration. This provides the first generic ...

FDA approves Rebif Rebidose(EMD Serono) for treatment of Multiple Sclerosis

The FDA has approved Rebif Rebidose, a single-use auto-injector prefilled with EMD Serono and Pfizer's interferon beta-1a, for the treatment of relapsing forms of Multiple Sclerosis (MS). Interferon beta-1a is an established and effective disease-modifying treatment for MS, but some people can struggle with injections, and the resulting drops in compliance mean the treatment is less effective.

...

NICE recommends Exogen (Bioventus) for treatment of long bone fractures

NICE has issued guidance on the use of Exogen, an ultrasound bone healing system from Smith & Nephew/Bioventus LLC, that benefits patients and the NHS when used for treating long bone fractures (bone fractures that have failed to heal after nine months). But NICE added that the case for adopting the device routinely for long bone fractures with delayed ...

Study finds CholestOff (Nature Made) reduces Cholesterol levels in patients with CV risk

A new study suggests CholestOff, a sterol/stanol ester-based softgel capsule, from Nature Made, offers benefits for decreasing LDL cholesterol in individuals with high Cholesterol levels. The randomized, placebo-controlled, crossover trial lasted 17 weeks during which all subjects followed a heart healthy diet (National Cholesterol Education Program TLC Diet). One group received a sterol/stanol softgel for 6 weeks while the other ...

FDA approves Kineret(SOBI) for NOMID

Sobi- Swedish Orphan has announced that the FDA has approved Kineret (anakinra) for the treatment of children and adults with Neonatal-Onset Multisystem Inflammatory Disease (NOMID).

Kineret is the first and only FDA-approved therapy for NOMID, the most severe form of cryopyrin associated periodic syndromes (CAPS). This is the first approval allowing the use of Kineret in children. Kineret was ...

Merck Inc re-files sugammadex at FDA

Merck Inc., has announced that the resubmission of the New Drug Application (NDA) for sugammadex sodium injection ,(known as Bridion in Europe), has been accepted for review by the FDA. Merck expects the FDA’s review to be completed in the first half of 2013.

Sugammadex sodium injection is an investigational agent for the reversal of neuromuscular blockade ...

Apremilast(Celgene) success in ESTEEM 1 & 2 trials for Psoriasis

Celgene International Sàrl, has announced that statistical significance for the primary endpoint of PASI 75 at week 16 was achieved for patients receiving apremilast 30 mg BID monotherapy in both the ESTEEM 1 & 2 phase III studies. ESTEEM 1 & 2 are the two pivotal phase III, randomized, placebo-controlled studies evaluating apremilast, the company’s oral small-molecule inhibitor of phosphodiesterase ...

BAX 855 enters Phase II/III study for Haemophilia

Baxter International Inc. has announced it has submitted an Investigational New Drug (IND) application for its investigational Haemophilia A treatment, BAX 855, with the FDA following positive results from a Phase I trial. BAX 855 is a full-length longer-acting recombinant factor VIII (rFVIII) that was developed to increase the half-life of Advate [Antihemophilic Factor (Recombinant) Plasma/Albumin-Free Method] - the most ...

Empagliflozin (Boehringer/Lilly) success in four Phase III trials for Type 2 Diabetes

Boehringer Ingelheim and Eli Lilly and Company have announced top-line results for four completed Phase III clinical trials for empagliflozin, an investigational sodium glucose co-transporter-2 (SGLT-2) inhibitor being studied for treatment of patients with Type 2 Diabetes (T2D). In all four studies, the primary efficacy endpoint, defined as significant change in HbA1c from baseline compared to placebo, was met ...

Biogen Idec files rFIXFc at FDA for treatment of Haemophilia B

Biogen Idec has submitted a Biologics License Application (BLA) to the FDA for the marketing approval of recombinant factor IX Fc fusion protein (rFIXFc) for the treatment of Haemophilia B.

rFIXFc is the first product candidate in a new class of long-lasting clotting factor therapies that are being developed with the goals of reducing the burden of treatment ...

FDA approves Celluma (BioPhotas) for treatment of Acne

The FDA has cleared Celluma, a biophotonic medical device, from BioPhotas, for six separate Indications-For-Use, including the treatment of Acne, Muscle and Joint Pain, muscle and joint stiffness, muscle spasm, Arthritis and compromised local blood circulation. Celluma provides light therapy to the body. It uses three distinct wavelengths of light, modulated with proprietary electronic algorithms to effectively treat a variety ...

Phase II success for AT 2220 in Pompe Disease

Amicus Therapeutics has announced positive preliminary results from all 4 dose cohorts in a Phase II study (Study 010) to evaluate the safety and pharmacokinetic (PK) effects of the pharmacological chaperone AT 2220 (duvoglustat HCl) co-administered with enzyme replacement therapy (ERT) for Pompe disease (Myozyme and Lumizyme). Myozyme and Lumizyme (alglucosidase alfa, or recombinant human GAA enzyme, rhGAA) are ...

IQWiG finds no additional benefit in Eklira Genuair (Almiral) in COPD treatment

IQWiG reports in a preliminary review of data of Eklira Genuair/Bretaris Genuair (aclidinium bromide) from Almiral compared to Spiriva (tiotropium) offers no additional benefit to COPD patients.

IQWiG is the German review organisation that carries out assessments under AMNOG for the G-BA which has the final decision in Germany.Some studies were too short and others had shortcomings. According ...

IQWiG review of Inlyta(Pfizer),Nexavar (Bayer)and Afinitor (Novartis) as treatments for Renal Cell Carcinoma

IQWiG, the German drug assessment agency,recommended that Inlyta (axitinib) from Pfizer offered considerable additional benefit in the treatment of Renal Cell Carcinoma compared to Nexavar(sorafenib) from Bayer HealthCare. However it also found that Inlyta gave no additional benefit over Afinitor (everolimus) from Novartis.

Data supporting Inlyta over Nexavar came from the AXIS study. IQWiG found no difference in ...

Nexavar (Bayer) success in Phase III trial for Thyroid Cancer

Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals have announced that a Phase III trial of Nexavar (sorafenib) tablets in patients with locally advanced or metastatic radioactive iodine (RAI)-refractory differentiated Thyroid Cancer has met its primary endpoint of a statistically significant improvement in progression-free survival. The study, called DECISION, evaluated the efficacy and safety of Nexavar compared to placebo. The safety and ...

Phase III study of LCP-Tacro (Veloxis Pharmaceuticals) shows drug is non-inferior to current treatment in Kidney Transplant patients

New data on the 3001 Study of LCP-Tacro, from Veloxis Pharmaceuticals, in stable Kidney Transplant patients has been published. This randomized, controlled, multicenter Phase III trial demonstrated that LCP-Tacro dosed once-daily was not inferior to the current leading transplant drug, Prograf, dosed twice-daily. Results demonstrated that patients can be successfully converted from twice-daily Prograf to once-daily LCP-Tacro, which may increase ...

Plecanatide (Synergy Pharma) success in Phase III trial for Constipation

Synergy Pharmaceuticals, Inc.has announced that plecanatide, its investigational oral drug for the treatment of Chronic Idiopathic Constipation (CIC), was well tolerated and met the primary and key secondary endpoints of a Phase IIb/III clinical study. Full study results will be presented at a major scientific meeting this year.

The randomized, double-blind, placebo-controlled, repeat-dose, dose-ranging study was designed to ...

Positive data from Phase II trial of Tolenix (TheraVida) for treatment of Overactive Bladder

TheraVida has announced positive results from a Phase II clinical trial of Tolenix (tolterodine and pilocarpine) for the treatment of Overactive Bladder (OAB) and urge urinary incontinence (UUI). The aims of this randomized, double-blinded, multiple-crossover trial were to assess the safety and efficacy of Tolenix in reducing the frequency of micturition and incontinence episodes per day, as compared to both ...

Dexpramipexole (Biogen Idec) fails Phase III EMPOWER trial in ALS

Biogen Idec has reported top-line results of EMPOWER, a Phase III trial investigating dexpramipexole in people with Amyotrophic Lateral Sclerosis (ALS). The trial did not meet its primary endpoint, a joint rank analysis of function and survival, and no efficacy was seen in the individual components of function or survival. The trial also failed to show efficacy in its key ...

FDA approves Xience Xpedition everolimus eluting cardiac stent (Abbott Vascular)

Abbott Vascular has announced that the Xience Xpedition Everolimus Eluting Coronary Stent System has received FDA approval and is launching immediately in the United States , providing physicians with a next-generation technology with the largest size matrix in the U.S. market.

Xience Xpedition features a new stent delivery system designed to optimize deliverability, particularly in challenging coronary anatomies. ...

FDA approves Fulyzaq (Salix Pharmaceuticals) for Diarrhoea in HIV/AIDS

The FDA has approved Fulyzaq (crofelemer 125 mg delayed-release) tablets, from Salix Pharmaceuticals, for the symptomatic relief of Diarrhoea in patients with HIV/ AIDS. Approval is based on a randomized, double-blind, placebo-controlled and placebo-free, multi-center study of 374 HIV-positive patients on antiretroviral therapy (ART), with a history of Diarrhoea for one month or more. The primary efficacy endpoint was the ...

FDA approves Sirturo (Janssen Therapeutics) for multi-drug resistant Tuberculosis

The FDA has granted accelerated approval to Sirturo (bedaquiline), from Janssen Therapeutics, for the treatment of pulmonary multi-drug resistant Tuberculosis (MDR-TB) as part of combination therapy in adults. The FDA accelerated approval is based on Phase II data from TMC207-C208 Study 1 and Study 2.

The primary endpoint was time to sputum culture conversion: the interval in days between the ...

AEZS-108 to commence Phase III trial for Endometrial Cancer

The FDA has approved an upcoming Phase III registration trial in Endometrial Cancer for AEZS-108 from Aeterna Zentaris Inc. This will be an open-label, randomized, multicenter Phase III trial conducted in North America and Europe, comparing AEZS-108 with doxorubicin as second line therapy for locally-advanced, recurrent or metastatic Endometrial Cancer. The trial will involve approximately 500 patients and the ...

FDA approves Eliquis (BMS/Pfizer) to reduce the risk of Stroke and Systemic Embolism

The FDA on 28 December 2012 approved the anti-clotting drug Eliquis (apixaban) from BMS/Pfizer, an oral tablet used to reduce the risk of Stroke and dangerous blood clots (Systemic Embolism) in patients with atrial fibrillation that is not caused by a heart valve problem.

The safety and efficacy of Eliquis in treating patients with atrial fibrillation not caused by ...

Abilify Depot is filed in EU for maintenance therapy of Schizophrenia

The European Medicines Agency (EMA) has accepted a marketing authorization application (MAA) for a once-monthly intramuscular depot formulation of Abilify (aripiprazole) from Otsuka Pharma and Lundbeck. The companies are seeking approval of the long-acting formulation of the dopamine D2 partial agonist as a maintenance therapy for adults with Schizophrenia....

FDA reviews Xiaflex (Auxilium Pharmaceuticals) for patients with Peyronie's disease

The FDA has accepted for filing and granted standard review status to its supplemental Biologics License Application (sBLA) for Xiaflex (collagenase clostridium histolyticum or CCH), from Auxilium Pharmaceuticals, for treatment of Peyronie's disease (PD). The FDA is expected to take action on the application by September 6, 2013. Xiaflex for the treatment of PD was granted orphan designation in the ...

FDA will review Procysbi (Raptor Pharma) in April 2013

Raptor Pharmaceutical Corp. announced that the FDA will require additional time to complete its review of the New Drug Application (NDA) for RP103 (Procysbi), for the potential treatment of Nephropathic Cystinosis. In a notice received from the FDA, the initial Prescription Drug User Fee Act (PDUFA) goal date has been extended from January 30, 2013 to April 30, 2013. The ...

Luveniq (Isotechnika) fails Phase III trial for treatment of Uveitis

Isotechnika Pharma Inc. announced that the Phase III clinical study using Luveniq (voclosporin) for the treatment of non-infectious Uveitis, conducted by Lux Biosciences, under a license agreement with Isotechnika, did not meet its primary endpoint of change from baseline in vitreous haze at 12 weeks or at the time of treatment failure, if earlier. As a result, Lux does ...

Phase III trial of OMS 103HP (Omeros Corp) shows pain reduction in patients after arthroscopic Surgery

New results from the first pivotal Phase III clinical trial evaluating OMS 103HP, from Omeros Corporation, in patients undergoing arthroscopic partial meniscectomy Surgery shows the drug provides significant reduction in pain. The trial's primary endpoint was the Symptoms Subscale of the Knee Injury and Osteoarthritis Outcome Score (KOOS) – a patient-reported measure comprised of questions about knee swelling, clicking, catching ...

FDA approves Juxtapid (Aegerion Pharma) for patients with Homozygous Familial Hypercholesterolemia

The FDA has approved Juxtapid (lomitapide), from Aegerion Pharma, as an adjunct to diet and other lipid-lowering treatments to reduce low-density lipoprotein cholesterol (LDL-C), total cholesterol (TC), apolipoprotein B (apo B) and non-high-density-lipoprotein cholesterol (non-HDL) in patients with Homozygous Familial Hypercholesterolemia (HoFH). The FDA based its approval on a pivotal Phase III study, which evaluated the safety and effectiveness of ...

Navidea Biopharma files Lymphoseek at EMA for Intraoperative Lymphatic Mapping

Navidea Biopharmaceuticals, Inc. a biopharmaceutical company focused on precision diagnostic radiopharmaceuticals, has announced that it has submitted a Marketing Authorization Application for its investigational radiopharmaceutical Lymphoseek (technetium Tc 99m tilmanocept) injection, a novel intraoperative lymphatic mapping agent, to the European Medicines Agency. Lymphoseek is used in intraoperative lymphatic mapping , a surgical oncology procedure used primarily in patients with ...

ViiV healthCare files dolutegravir for HIV treatment in EU, US and Canada

ViiV Healthcare has announced the submission of regulatory applications in the European Union , United States and Canada for the investigational integrase inhibitor dolutegravir (S/GSK1349572) for the treatment of HIV infection in adults and adolescents, specifically: -A Marketing Authorisation Application to the European Medicines Agency for dolutegravir for the treatment of HIV infection in adults and children aged 12 ...

FDA approves Gattex (NPS Pharma) for adult patients with Short Bowel Syndrome

The FDA has approved Gattex (teduglutide), from NPS Pharma, for subcutaneous use for the treatment of adult patients with Short Bowel Syndrome (SBS) who are dependent on parenteral support. The drug was approved in the EU in September 2012 as Revestine. Gattex will be available in the first quarter of 2013.

The FDA's approval of Gattex was based on an international, ...

FDA approves VariZIG (Cangene Corpn) for Chicken Pox treatment

The FDA on 21 December 2012 approved VariZIG,a varicella zoster immune globulin preparation from Cangene Corporation, for reducing the severity of Chicken Pox (varicella zoster virus) infections in high risk individuals when given within four days after exposure. Varicella zoster immune globulin (VZIG) has been shown to lower the risk of severe infections if given soon enough after exposure. An ...

FDA rejects Ampligen (Hemispherx) as a treatment for Chronic Fatigue Syndrome

The FDA Arthritis Advisory Committee rejected the re-application by Hemispherx for Ampligen (rinatatolimod) as a treatment for Chronic Fatigue Syndrome. The Committee voted 8 votes to 5 votes to reject the drug. The FDA was unimpressed with the clinical trial evidence as to efficacy, but accepted that the drug was safe. There are currently no approved treatments for Chronic Fatigue ...

EU Commission approves Exjade (Novartis) for treatment of Iron Overload with Thalassemia Syndromes

Novartis announced that the European Commission has approved Exjade (deferasirox) for the treatment of chronic iron overload requiring chelation therapy when deferoxamine therapy is contraindicated or inadequate in patients aged 10 years and older with non-transfusion-dependent thalassemia (NTDT) syndromes. Exjade is the first oral treatment approved in the European Union (EU) specifically indicated for the treatment of chronic iron ...

FDA approves Bivigam (Biotest Pharmaceuticals Corporation) for Primary Humoral Immunodeficiency

The FDA has given Biotest Pharmaceuticals Corporation approval for Bivigam for the treatment of patients with Primary Humoral Immunodeficiency. Approval is based on a pivotal clinical study which successfully achieved its primary endpoints for safety, efficacy and tolerability. The results were recently published in the Journal of Clinical Immunology (Wassermann RL, Church JA, Stein M, et al. "Safety, efficacy and ...

Tredaptive (Merck Inc) fails in HPS2-THRIVE trial

The HPS2-THRIVE (Heart Protection Study 2-Treatment of HDL to Reduce the Incidence of Vascular Events) study of Tredaptive(extended-release niacin/laropiprant) did not meet its primary endpoint. Merck Inc., and the investigators are informing regulatory agencies of these results. The company is also preparing communications to health care providers in countries where the medicine is currently available, and will continue to ...

Davunetide (Allon Therapeutics) fails trial for Supranuclear Palsy

Allon Therapeutics Inc. has announced that its pivotal clinical trial evaluating its lead product candidate davunetide as a treatment for progressive supranuclear palsy (PSP) failed to demonstrate efficacy in this population. The study had co-primary outcome measures: the Progressive Supranuclear Palsy Rating Scale (PSPRS), and the Schwab and England Activities of Daily Living (SEADL). Data analysis failed to detect an ...

Migalastat (Amicus/GSK) disappoints in Phase III trial for Fabry Disease

Amicus Therapeutics and GSK announced the 6-month primary treatment period results from the first Phase III global registration study (Study 011) of investigational oral migalastat HCl monotherapy in males and females with Fabry Disease who had genetic mutations identified as amenable to migalastat HCl in a cell-based assay.

GL-3 clearance from the kidney interstitial capillaries is used as a ...

Phase II study of RiaSTAP (CSL Behring) shows the drug has benefits in Critical Care patients

Clinical study results show that RiaSTAP (fibrinogen concentrate [human]), from CSL Behring, can significantly reduce the need for blood transfusion when given in a Critical Care situation, as an intra-operative, targeted first-line hemostatic therapy in bleeding patients undergoing aortic replacement surgery. The Phase II prospective study, led by Niels Rahe-Meyer of the Clinic for Anesthesiology and Intensive Care Medicine, at ...

Phase III trials of TMC 435 (Medivir/Tibotec) show positive response in patients with Hepatitis C

Top-line results from three pivotal Phase III trials examining TMC 435 (simeprevir, from Medivir/Tibotec, administered with pegylated interferon and ribavirin found that 80% and 81% of treatment-naive patients with chronic genotype 1 Hepatitis C infection who were treated with simeprevir achieved sustained virologic response 12 weeks after the planned end of treatment (SVR12). These results were from QUEST-1 and QUEST-2 ...

Results of Phase III studies show substantial benefits of ACZ 885 (Novartis) in patients with Juvenile Idiopathic Arthritis

Results of two Phase III trials show ACZ 885 (canakinumab), from Novartis, provided substantial symptom relief in young patients with systemic Juvenile Idiopathic Arthritis (SJIA). In addition, ACZ 885 delayed disease flare recurrence and allowed patients to substantially reduce or discontinue use of corticosteroids.

In beta-SPECIFIC 1 (trial-1), 84% of SJIA patients treated with ACZ 885 experienced at least a ...

Botox (Allergan) approved in Ireland for treating Overactive Bladder, the first step towards EU-wide approval

Botox (botulinum toxin type A), from Allergan, has received a positive opinion from the Irish Medicines Board for the treatment of idiopathic Overactive Bladder with symptoms of urinary incontinence, urgency and frequency in adult patients who have an inadequate response to, or are intolerant of, anticholinergic medications. Ireland serves as the Reference Member State in the Mutual Recognition Procedure that ...

Early study shows Dantrium (JHP Pharmaceuticals) has promise for treating Duchenne Muscular Dystrophy

Scientists at UCLA have found Dantrium (sodium dantrolene), from JHP Pharmaceuticals, provides a powerful boost to drug therapy for Duchenne Muscular Dystrophy. The hope is that when used in combination, the drug will provide a one-two punch that will overcome the genetic mutations that cause Duchenne Muscular Dystrophy, and restore a missing protein needed for proper muscle function, and ...

Further positive results for Symplicity (Medtronic) Renal Dernervation System

Medtronic, Inc. has announced one-year results from Symplicity HTN-2, the first randomized clinical trial investigating renal denervation for Resistant Hypertension, that were published online before print in Circulation, the Journal of the American Heart Association.

These data showed patients who initially received treatment with the Symplicity renal denervation system (n=47) sustained a significant drop in blood pressure (-28/-10 ...

GSK/Theravance file GSK 573719 plus vilanterol at the FDA for COPD

GlaxoSmithKline plc (GSK) and Theravance, Inc. have announced the submission of a regulatory application in the US for the investigational once-daily LAMA/LABA combination medicine, UMEC/VI, for patients with Chronic Obstructive Pulmonary Disease (COPD).

UMEC/VI is a combination of two investigational bronchodilator molecules -- GSK 573719 or umeclidinium bromide (UMEC), a long-acting muscarinic antagonist (LAMA) and vilanterol (VI), a ...

Phase III trial of Stimuvax (Merck Serono) fails to meet primary endpoint in patients with NSCLC

The Phase III START study, a trial of L-BLP25 (formerly called Stimuvax), from Merck Serono, in patients with unresectable, locally advanced stage IIIA or IIIB Non-Small Cell Lung Cancer (NSCLC) failed to meet its primary endpoint of demonstrating a statistically significant improvement in overall survival. No new or unexpected safety concerns were noted for the study. In prior clinical studies, ...

Positive results in Phase III trial of Jakafi (Incyte Corporation/Novartis) for patients with Myelofibrosis

New results from the Phase III COMFORT-II study shows that Jakafi(ruxolitinib), from Incyte Corporation, reduces splenomegaly and other symptoms commonly associated with Myelofibrosis. In addition, benefits are maintained for at least two years.

In a follow-up of 112 weeks, of patients randomised to receive either oral ruxolitinib or conventional therapy, just under half of patients receiving ruxolitinib achieved better than ...

Successful Phase II trial for ponesimod (Actelion) in Plaque Psoriasis

Actelion has announced that its selective S1P1 modulator, ponesimod, successfully met the primary endpoint - the proportion of patients with at least 75% improvement in Psoriasis Area and Severity Index (PASI) from baseline (PASI75) at week 16 - in a double blind, placebo-controlled study conducted in 326 patients with moderate to severe chronic Plaque Psoriasis. Results of the primary ...

Tasimelteon (Vanda)success in Phase III study in Non 24 Hour Disorder

Vanda Pharmaceuticals has announced positive results from the SET (Safety and Efficacy of Tasimelteon) Phase III study, evaluating tasimelteon, a circadian regulator for the treatment of Non-24-Hour Disorder (Non-24). Tasimelteon succeeded in the primary endpoint of Entrainment of the melatonin (aMT6s) rhythm as compared to placebo. Additionally, tasimelteon demonstrated significant improvements across a number of sleep and wake parameters including ...

Antares Pharma files Otrexup at FDA for Rheumatoid Arthritis

Antares Pharma has submitted a New Drug Application (NDA) to the FDA for Otrexup, a combination product for the delivery of methotrexate (MTX) using Medi-Jet technology. Otrexup was developed for easy subcutaneous administration of MTX to enhance the treatment of rheumatoid arthritis (RA), poly-articular-course juvenile RA and moderate to severe psoriasis....

NICE does not recommend Avastin (Roche) as a treatment for Ovarian Cancer

The National Institute for Health and Clinical Excellence (NICE) has published draft guidance on the use of Avastin(bevacizumab) from Roche, as a treatment for women with advanced Ovarian Cancer. The draft guidance does not recommend the use of bevacizumab when used with paclitaxel and carboplatin for people with advanced disease, as a cost-effective treatment for the National Health Service....

NICE recommends Revolade (GSK) for ITP

The National Institute for Health and Clinical Excellence(NICE) now recommends the use of Revolade (eltrombopag olamine)for patients with the bleeding disorder Chronic Immune Thrombocytopenic Purpura (ITP). The recommendation is for use of the drug for treating ITP in patients who have had their spleens removed or those refractory to other treatments, or as a second line treatment in those who ...

Positive European regulatory procedure for Elvanse (Shire) for ADHD

Shire plc announced a positive outcome from the European Decentralised Procedure (DCP) for Elvanse (to be known as Tyvense in Ireland). Elvanse is indicated as part of a comprehensive treatment programme for Attention Deficit/Hyperactivity Disorder (ADHD) in children aged 6 years of age and over when response to previous methylphenidate treatment is considered clinically inadequate. The MHRA of the UK, ...

FDA approves Fluarix Quadrivalent (GSK) Influenza vaccine

The FDA has approved Fluarix Quadrivalent Influenza Virus Vaccine from Glaxo Smith Kline, for the immunisation of children (three years and older) and adults to help prevent disease caused by seasonal influenza (flu) virus subtypes A and type B contained in the vaccine. Fluarix Quadrivalent is the first intramuscular vaccine to cover against four influenza strains....

CHMP recommends Perjeta (Genentech/Roche) for HER2+ Breast Cancer

The CHMP has given a positive opinion for the use of Perjeta (pertuzumab) in combination with Herceptin (trastuzumab) and docetaxel in patients with HER2-positive metastatic or locally recurrent unresectable Breast Cancer (mBC). The recommendation supports an indication for people with this specific type of cancer who have not received prior anti-HER2 therapy or chemotherapy for their metastatic disease. The CHMP ...

BayerHealthCare submits Alpharadin to FDA for treatment of castration-resistant Prostate Cancer

Bayer HealthCare has submitted a New Drug Application to the FDA seeking approval for Alpharadin (radium-223 dichloride (radium-223)) for the treatment of castration-resistant Prostate Cancer in patients with bone metastases. The treatment has been granted fast track designation by the FDA.

The submission was based on data from the ALSYMPCA trial, a Phase III, randomized, double-blind, placebo-controlled international study ...

FDA approves Iclusig(Ariad Pharma) for CML and Ph+ ALL

Ariad Pharmaceuticals Inc. announced that following a priority review, the FDA on 14 December 2012, has granted accelerated approval of Iclusig (ponatinib) for the treatment of adult patients with chronic, accelerated or blast phase Chronic Myeloid Leukemia (CML) that is resistant or intolerant to prior tyrosine kinase inhibitor (TKI) therapy or Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) that ...

FDA approves raxibacumab (Human Genome Sciences/GSK) to treat Anthrax

The FDA approved raxibacumab injection, from Human Genome Sciences/GSK, on 14 December 2012, to treat inhalational Anthrax, a form of the infectious disease caused by breathing in the spores of the bacterium Bacillus anthracis. Raxibacumab also is approved to prevent inhalational anthrax when alternative therapies are not available or not appropriate.

Raxibacumab is the first monoclonal antibody approved under ...

FDA approves Signifor (Novartis) for treatment of Cushings Disease

The FDA has approved Signifor (pasireotide) injection from Novartis, for the treatment of adult patients with Cushing's Disease for whom pituitary surgery is not an option or has not been curative. Signifor is the first medicine to be approved in the US that addresses the underlying mechanism of Cushing's Disease, a serious, debilitating endocrine disorder caused by the presence ...

Phase III study of Sufentanil NanoTabs (AcelRX Pharmaceuticals) shows non-inferiority to morphine for Acute Pain

Top-line results of the Phase III clinical trial demonstrate that in treating Acute Pain, the Sufentanil NanoTab PCA System, from AcelRX Pharmaceuticals, was non-inferior to intravenous (IV) patient-controlled analgesia (PCA) with morphine as determined by the combined percentage of patients with Patient Global Assessment (PGA) ratings of "good" or "excellent" (78.5% vs. 66.1% respectively). This statistically superior PGA was also ...

CHMP recommends Adusive (Alexza/Ferrer)for control of agitation in Schizophrenia and Bipolar patients

Alexza Pharmaceuticals, Inc. and Grupo Ferrer Internacional, S.A., have announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency adopted a positive opinion recommending that Adasuve (Staccato loxapine) be granted European Union centralized marketing authorization. The CHMP recommends that Adasuve be authorized in the EU for the rapid control of mild-to-moderate agitation in adult ...

CHMP recommends Selincro (Biotie/Lundbeck) for treatment of Alcholol Dependence

Biotie announced that its partner H.Lundbeck A/S (Lundbeck) has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency recommending marketing authorization of Selincro (nalmefene; an opioid system modulator) for the reduction of alcohol consumption in adult patients with Alcohol Dependence who have a high level of alcohol consumption. Once approved, ...

CHMP rejects Fanaptum (Vanda Pharma)for treatment of Schizophrenia

Vanda Pharmaceuticals Inc. has announced that the European Medicines Agency's Committee for Medicinal Product for Human Use (CHMP) has issued a negative opinion recommending against approval of Fanaptum (oral iloperidone tablets) for the treatment of Schizophrenia in adult patients in the European Union. The CHMP was of the opinion that the benefits of Fanaptum did not outweigh its risks and ...

CHMP rejects Kynamro (Sanofi) for treatment of Homozygous Familial Hypercholesterolemia

Genzyme, a Sanofi company and Isis Pharmaceuticals Inc. have announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a negative opinion for its marketing authorization application for Kynamro (mipomersen) for the treatment of patients with Homozygous Familial Hypercholesterolaemia (HoFH). Genzyme plans to request a re-examination of the CHMP Opinion....

New assessment of evidence for the effectiveness of TAVI rates the technique's benefits as 'moderate'

The ECRI Institute, a nonprofit organization that researches the best approaches to improving patient care, has evaluated the evidence behind the use of the only transcatheter heart valve approved for marketing in the US and Europe in transcatheter aortic valve implantation (TAVI). Based on the results of its systematic search of the literature for clinical studies that compared the device ...

Positive results in Phase II study of BI 6727 (Boehringer) in patients with AML

Phase II results from an interim analysis of a study involving BI 6727 (volasertib), from Boehringer, in newly diagnosed patients with Acute Myeloid Leukemia (AML) shows higher rates of objective response and an improvement in event free survival in patients treated with volasertib in combination with low-dose cytarabine (LDAC), compared to patients treated with LDAC alone. Objective responses were observed ...

BayerHealthCare submits Alpharadin to EMA for treatment of castration-resistant Prostate Cancer

Algeta ASA announces that Bayer HealthCare has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for Alpharadin (radium-223 dichloride (radium-223)) for the treatment of castration-resistant Prostate Cancer in patients with bone metastases.

The submission is based on data from the pivotal phase III ALSYMPCA (ALpharadin in SYMptomatic Prostate CAncer) trial, which was conducted by Algeta. ...

BOLERO-2 18-month follow-up shows benefits with Afinitor/Aromasin combination (Novartis/Pfizer) in Breast Cancer patients

Results from the Phase III BOLERO-2 trial show that the effects on survival observed with the Novartis drug Afinitor (everolimus) plus Aromasin (exemestane), from Pfizer, in women with Breast Cancer is maintained after 18 months. The trial studied the efficacy and safety of the two drugs versus placebo plus exemestane, in postmenopausal women with hormone receptor-positive advanced Breast Cancer that ...

Janssen Pharmaceuticals submits NDA to FDA for combined TA 7284 and metformin treatment for Type 2 Diabetes

Janssen Pharmaceuticals has submitted a New Drug Application to the FDA seeking approval for a fixed-dose therapy combining TA 7284 (canagliflozin) and immediate release metformin to treat patients with Type 2 Diabetes. A significant portion of the clinical data in this NDA are derived from the global Phase III clinical development program for canagliflozin, which were included in the NDA ...

New trial planned for solanezumab (Eli Lilly) for mild Alzheimers Disease treatment

Eli Lilly and Company has provided an update on the next steps planned for solanezumab, its Phase III monoclonal antibody being studied as a potential therapy for patients with mild Alzheimer's disease. Following discussions with regulators in the U.S., Europe and Canada, Lilly plans to conduct an additional Phase III study of solanezumab in patients with mild Alzheimer's disease. Additional ...

NICE recommends Yervoy (BMS) and Zelboraf (Roche) for Melanoma

NICE, The National Institute of Health and Clinical Excellence, has provided final and binding guidance that recommends both Yervoy (ipilimumab) from BMS and Zelboraf (vemurafenib) from Roche, for melanoma patients. Both recommendations were conditioned on a discount offered under a patient access scheme. Yervoy is recommended for the treatment of advanced Malignant Melanoma in people who have received prior ...

Pfizer files Aprela at FDA for Menopausal Symptoms and Prevention of Osteoporosis

Pfizer Inc. and Ligand Pharmaceuticals Incorporated have announced that the FDA accepted for review a New Drug Application for Aprela ( bazedoxifene/conjugated estrogens ), a potential new medicine for non-hysterectomized women for the treatment of moderate-to-severe vasomotor symptoms and vulvar and vaginal atrophy associated with Menopause, as well as the prevention of postmenopausal Osteoporosis. The FDA Prescription Drug User Fee ...

Phase II study success of quizartinib (Astellas/Ambit Bioscience) in AML

Astellas Pharma Inc. and Ambit Biosciences Corporation announced the results from a completed Phase II study with the investigational FLT3 inhibitor, quizartinib (AC220), as an oral monotherapy treatment regimen in patients with relapsed or refractory Acute Myeloid Leukemia (AML). Data from two study cohorts (patients aged ? 60 years with AML relapsed in <1 year or refractory to 1st-line chemotherapy; ...

Phase IIb report of fostamatinib (AstraZeneca) OSKIRA-4 trial for RA

AstraZeneca announced top-line results of OSKIRA-4, a Phase IIb monotherapy study of fostamatinib, the first kinase inhibitor with selectivity for SYK (spleen tyrosine kinase) in development as an oral treatment for rheumatoid arthritis (RA). OSKIRA-4 was a six month study evaluating improvements in signs and symptoms of RA in 280 patients who had never previously used a disease-modifying anti-rheumatic ...

Study shows benefits for bone growth in infants fed on InFat (Advanced Lipids)

A randomized, double-blind, controlled clinical trial on bone strength in term infants fed InFat, a high beta-palmitate formula, from Advanced Lipids, indicates InFat leads to significantly higher bone-strength parameters compared to a standard vegetable oil control. The trial studied the effect of 12 weeks feeding of infant formula with InFat on bone strength parameters. Bone strength results were measured by ...

Phase II study of PCI 32765 (Pharmacyclics Inc) shows some benefits in patients with Mantle Cell Lymphoma

Findings from an ongoing, open-label, Phase II, single-agent study shows that in patients with relapsed or refractory Mantle Cell Lymphoma (MCL), PCI 32765 (ibrutinib), from Pharmacyclics Inc., resulted in an overall response rate of 68 percent, including a complete response of 22 percent and a partial response of 46 percent. The study included both bortezomib-naive and bortezomib-exposed patients; 111 received ...

The Medicines Company and BMS collaborate in marketing Recothrom for Haemostasis.

The Medicines Company and Bristol-Myers Squibb Company announced that the companies have signed a global license and two year collaboration for Recothrom, a recombinant thrombin approved by the FDA for use as a topical hemostat to control non-arterial bleeding during surgical procedures.Recothrom was approved by the FDA in January 2008 and is marketed in Canada by Bayer HealthCare....

FDA approves NavioPFS orthopedic surgical system (Blue Belt Technologies) for Knee Replacement

Blue Belt Technologies has received 510(k) clearance from the FDA to market its NavioPFS orthopedic surgical system. The clearance is for Unicondylar Knee Replacement, commonly known as partial Knee Replacement. The NavioPFS system incorporates technology to provide precision information to surgeons via smart instrumentation with robotic control. It delivers intra-operative navigation and 3D visualization during the surgery based on a ...

FDA expands Zytiga (Janssen Biotech) indication in Prostate Cancer

The FDA has expanded the approved use of Zytiga (abiraterone acetate) from Janssen Biotech, to treat men with late-stage (metastatic) castration-resistant Prostate Cancer prior to receiving chemotherapy. The FDA initially approved Zytiga in April 2011 for use in patients whose Prostate Cancer progressed after treatment with docetaxel, a chemotherapy drug. Zytiga is a pill that decreases the production of male ...

FDA updates prescribing information for Edurant (Tibotec) for AIDS patients

The FDA has approved a prescribing information update for Edurant (rilpivirine) tablets, from Tibotec, to include 96-week pooled data from the Phase III ECHO and THRIVE studies, which evaluated the efficacy and safety of Edurant for the treatment of Human Immunodeficiency Virus type 1 (HIV-1) in antiretroviral treatment-naive adults. In addition to the inclusion of the 96-week data in the ...

Two Phase III trials show benefits of Tasigna (Novartis) for patients with Ph+ CML

New results from two Phase III clinical trials further establish the benefits of Tasigna (nilotinib), from Novartis, compared to Gleevec (imatinib mesylate) in the treatment of Philadelphia chromosome-positive Chronic Myeloid Leukemia (Ph+ CML) in newly diagnosed patients and in those with residual disease who switched to Tasigna after long-term treatment with Gleevec. Two-year results from ENESTcmr showed that switching to ...

FDA Advisory Committee rejects Zohydro for Chronic Pain treatment

The FDA Anasthetic and Analgesic Advisory Committee found Zohydro (hydrocodone bitartrate extended-release capsules)from Zogenix, was effective in managing Moderate to Severe Pain when a continuous round -the -clock opioid analgesic is needed but was not comfortable with the lack of an abuse deterrent mechanism and voted 11-2 to reject the drug....

Phase III results for BAX 326 (Baxter) for Haemophilia B

A Phase I/III prospective, controlled, multicenter study investigated the pharmacokinetics, efficacy and safety of BAX 326 from Baxter, in 73 previously-treated patients with severe or moderately severe Hemophilia B.

Results from the study showed that twice-weekly prophylactic treatment with BAX 326 achieved a median annualized bleed rate of 1.99 with 43 percent of patients experiencing no bleeds. The ...

Phase III trial success for PCI 32765 (Janssen Biotech) in CLL treatment

Research demonstrates that PCI 32765 (ibrutinib) from Pharmacyclics/Janssen Biotech, may be an effective and safe targeted treatment option for previously untreated, hard-to-treat, and relapsed patients with Chronic Lymphocytic Leukemia (CLL).

A study enrolled 116 CLL patient participants in several treatment cohorts: patients who were never treated (the treatment-naive group), those who had received two or more prior therapies ...

Precision Spectra Spinal Cord Stimulator (Boston Scientific) receives CE Mark

Boston Scientific Corporation has received CE Mark approval and has begun the European market launch of the Precision Spectra Spinal Cord Stimulator (SCS) System. The Precision Spectra System is the world's first and only SCS system with 32 contacts and 32 dedicated power sources and is designed to provide improved pain relief to a wide range of patients who suffer ...

NICE rejects Inlyta(Pfizer) for treatment of Renal Cell Carcinoma

NICE, the healthcare guidance body, has issued draft guidance not recommending Inlyta (axitinib) from Pfizer, for the treatment of advanced Kidney Cancer.The preliminary decision by the independent Appraisal Committee is that axitinib should not be recommended for the treatment of advanced Renal Cell Carcinoma after failure of prior treatment with sunitinib or a cytokine. The trial data included a ...

Positive data from Phase III study of Eliquis (BMS/Pfizer) for VTE prevention

Results of the Phase III AMPLIFY-EXT trial evaluating Eliquis (apixaban), from BMS/Pfizer, vs placebo for preventing VTE, shows it demonstrated superiority in reducing recurrent VTE and death from any cause (11.6% in the placebo group, compared with 3.8% and 4.2% in the Eliquis groups. Eliquis also was superior to placebo for the predefined secondary efficacy outcome of recurrent VTE and ...

Roche submits extension application to EMA for subcutaneous MabThera

Roche has submitted a line extension application to the European Medicines Agency for a subcutaneous (SC) formulation of MabThera (rituxumab) for patients with Non-Hodgkin Lymphoma. Currently, MabThera is available as an IV formulation. The application is backed by pivotal study data which showed that SC administration of MabThera enabled the delivery of MabThera over approximately five minutes without compromising its ...

FDA approves Evarrest (Ethicon Biosurgery) for problematic bleeding during Surgery

The FDA has approved Evarrest fibrin sealant patch, from Ethicon Biosurgery, a product that rapidly aids in stopping problematic bleeding during Surgery. Evarrest consists of a coating of biologics and a flexible patch that work together to encourage the hemostasis process. Clinical studies demonstrate that Evarrest is 98% effective in stopping bleeding and maintaining hemostasis compared to the current standard ...

Updated survival results from CLEOPATRA Phase III trial for Perjeta(Genentech) in Breast Cancer treatment

Genentech,/Roche), announced updated survival results from the Phase III CLEOPATRA study, which showed that the combination of Perjeta (pertuzumab), Herceptin (trastuzumab) and docetaxel chemotherapy significantly extended the lives (overall survival) of people with previously untreated HER2-positive metastatic breast cancer (mBC), compared to Herceptin, chemotherapy and placebo.

Results showed that the risk of death was reduced by 34 percent for ...

Phase II study of XL 184 (Exelixis) shows significant improvement in patients with castration-resistant Prostate Cancer

About two-thirds of patients with castration-resistant Prostate Cancer treated with XL 184 (cabozantinib), from Exelixis, had improvements on their bone scans, with 12 percent seeing complete resolution of uptake on bone scan, according to results of a Phase II study. The trial enrolled 171 men with castration-resistant Prostate Cancer, and began as a randomized trial in which all patients received ...

Phase II trial of GLYX 13 (Naurex) shows positive results in patients with Depression

Phase IIa results show that a single administration of anti-depressant GLYX 13, from Naurex, produced statistically significant reductions in Depression scores in subjects who had failed treatment with one or more antidepressant agents. The reductions were evident within 24 hours and persisted for an average of seven days. Importantly, the effect size, a measure of the magnitude of the drug's ...

PTC Therapeutics submits PTC 124 to the EMA for treatment of patients with Duchenne Muscular Dystrophy

A Marketing Authorization Application to the EMA seeking conditional approval for PTC 124 (ataluren), from PTC Therapeutics, for the treatment of patients with nonsense mutation Duchenne Muscular Dystrophy (nmDMD) has been accepted. Validation of the MAA confirms that the submission is complete and begins the EMA's Committee for Human Medicinal Products' (CHMP) review process.

The submission is based on a ...

Stelara (J&J Janssen Cilag/Janssen Biotech) filed with FDA and EMA to treat adults with active Psoriatic Arthritis

Janssen Biotech and J&J Janssen Cilag have submitted a supplemental Biologics License Application (sBLA) to the FDA and a Type II Variation to the EMA requesting approval of Stelara (ustekinumab) for the treatment of adult patients with active Psoriatic Arthritis. These applications are supported by findings from Phase III multicenter, randomised, double-blind, trials of ustekinumab PSUMMIT I and PSUMMIT II, ...

Trial of Reminyl XL/Razadyne (Janssen Pharmaceuticals) shows positive results in patients with Alzheimer's Disease

A new study shows a significantly lower mortality rate in patients with mild to moderately severe Alzheimer's disease who were treated with Reminyl XL/Razadyne (galantamine), from Janssen Pharmaceuticals, versus those on placebo. Patients treated with galantamine also had significantly lesser decline in cognitive impairment after two years.

The trial enrolled 2,051 people and was conducted at 127 sites in 13 ...

Rencarex (WILEX) programme in Renal Cell Carcinoma is cancelled

WILEX AG has agreed a package of restructuring measures with the company's Supervisory Board. The Executive Management Board is reacting to the results of the Phase III ARISER study with Rencarex which missed the primary endpoint. The measures are designed to tailor development activities to the remaining projects, reduce the risks inherent in the business model and lower operating ...

EU award CE mark approval to ExAblate Neuro System (InsighTec) for treatment of neurological disorders in the brain

The EU has awarded the ExAblate Neuro System, from InsighTec, the European CE mark for the treatment of neurological disorders in the brain including essential tremor, Parkinson's disease and neuropathic pain. InSightec recently received its second ExAblate FDA approval for the treatment of painful bone metastases in patients who are unable or unwilling to undergo radiation. This is in addition ...

EU awards CE mark to Revivent Myocardial Anchoring System (BioVentrix) for Heart Failure patients

BioVentrix has received the CE mark for its Revivent Myocardial Anchoring System, a surgical device that offers Heart Failure patients an alternative therapy to surgical ventricular restoration. The Revivent system is comprised of a series of titanium anchor pairs, each consisting of an internal anchor and an external anchor, which are introduced by transmural catheters. Once the desired number of ...

FDA give 510(k) approval for NeuViz 64 CT Imaging System (Neusoft Medical)

The NeuViz 64 multi-slice CT scanner (Neusoft Medical) has received FDA 510(k) clearance. The NeuViz 64 design delivers low-dose scanning, high patient throughput, and performs advanced Cardiac Imaging along with a wide variety of clinically-relevant post processing and diagnostic techniques. Neusoft Medical is based in Shenyang, China. In 2004, Neusoft Medical Systems signed a joint venture with Philips (Netherlands) to ...

Jaydress (Bayer)levonorgestrel-releasing intrauterine contraceptive is EU approved

Bayer HealthCare has successfully concluded the European registration procedure for its new low dose levonorgestrel-releasing intrauterine system (IUS) called Jaydress. This long-term contraceptive is placed in the uterus for the prevention of pregnancy for up to three years. Sweden served as Reference Member State for the Decentralized Procedure to gain EU-wide marketing authorization for the new IUS. Based on the ...

MK 8931 enters Phase II/III trial for Alzheimers Disease

Merck Inc., announced it has started a Phase II/III clinical trial designed to evaluate the safety and efficacy of MK-8931 versus placebo in patients with mild-to-moderate Alzheimer's Disease. MK-8931 is Merck's novel investigational oral beta-amyloid precursor protein site-cleaving enzyme (BACE) inhibitor, and is the first with this mechanism to advance to this stage of clinical research. The global, multi-center study, ...

Early trial shows promising results with simvastatin in Wound Healing

An lab-based trial has found that topically applied generic statin simvastatin accelerates Wound Healing in diabetic mice, with important implications if the effect occurs in humans with Diabetes. The investigators treated wounds on mice with an application of either simvastatin in petroleum jelly or petroleum jelly alone. Treatment was repeated on days four, seven, and ten. After two weeks, the ...

Phase II success for AM 111 (Auris Medical) for acute sensorineural hearing loss

Auris Medical has announced positive results from a Phase IIb clinical trial with AM-111, its investigational drug for the intratympanic (i.t.) treatment of acute sensorineural hearing loss (ASNHL). The study demonstrated that the treatment was well tolerated and showed a statistically significant and clinically relevant treatment effect.

The double-blind, randomized, placebo-controlled phase IIb study with AM-111 involved a total ...

Orphan Europe acquires European rights to GRASPA for ALL

Recordati announces that its subsidiary Orphan Europe and Erytech Pharma, a late development stage French biopharmaceutical company focused on orphan oncology and rare diseases, have entered into an agreement granting Orphan Europe the exclusive rights for the commercialization and distribution of Graspa for the treatment of Acute Lymphoblastic Leukemia (ALL) and Acute Myeloid Leukemia (AML) in Europe. Graspa, (human erythrocytes ...

FDA Advisory Committee recommends bedaquiline (Janssen)for treatment of Tuberculosis

Janssen Research & Development, LLC (Janssen) has announced that the Anti-Infective Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA), in a unanimous vote (18-0), agreed that the efficacy findings for investigational bedaquiline support the proposed indication for the treatment of pulmonary multi-drug resistant Tuberculosis (MDR-TB) as part of combination therapy in adults. The committee agreed in a ...

New analysis explains competing findings in studies of omega-3 fatty acids and impact on CV Risk

A new analysis has sorted through many of the competing findings from studies of omega-3 fatty acids, and helps to explain why so many of the studies seem to arrive at differing conclusions.

The study, by scientists in the Linus Pauling Institute at Oregon State University and published in the Journal of Lipid Research, concludes that both fish consumption and ...

New Phase II trial shows combination treatment with selumetinib (AstraZeneca) has promise for patients with NSCLC

A new Phase II study finds that the combination of selumetinib, from AstraZeneca, and docetaxel, was more effective than docetaxel chemotherapy alone for patients with a form of Non-Small Cell Lung Cancer (NSCLC) that carries a mutation in the gene KRAS - representing about 20 percent of all NSCLC cases. Previously, no targeted agent had proven beneficial in a trial ...

Study shows PET scans with Amyvid (Cardinal Health) provides significant value in treating patients with cognitive impairment

Results of a new study to assess the value of Amyvid (florbetapir F18) PET, from Cardinal Health, in detecting brain amyloid deposits associated with Alzheimer disease in patients with cognitive impairment, and in helping with clinical decision-making, shows the technique can play a significant role. The study included 229 patients previously evaluated for cognitive decline or impairment of uncertain etiology. ...

FDA Advisory Committee gives restricted recommendation for Vibativ (Theravance) for Nosocomial Pneumonia

The Advisory Committee (AIDAC) of the FDA has voted 9-6 that data, from Theravance relative to Vibativ (telavancin), failed to provide substantial evidence of the safety and effectiveness of Vibativ in treating Nosocomial Pneumonia (NP) including ventilator-associated pneumonia, caused by the susceptible Gram-positive microorganisms Staphylococcus aureus, including methicillin-resistant isolates (MRSA), and Streptococcus pneumoniae.

However in a 13-2 vote, the ...

FDA approves Cometriq (Exelixis Inc.) for treatment of Thyroid Cancer

The FDA on 29 November 2012 approved Cometriq (cabozantinib),formerly XL 184, from Exelixis Inc., to treat medullary Thyroid Cancer that has spread to other parts of the body (metastasized).

Cometriq is the second drug, with Caprelsa approved in April 2011 ,to treat medullary Thyroid Cancer in the past two years. The drug extended progression free survival for patients in a ...

European Commission approves Constella(Almirall/Ironwood) for Irritable Bowel Syndrome with Constipation

Almirall, S.A. and Ironwood Pharmaceuticals, Inc. announced that the European Commission has granted marketing authorization to Constella (linaclotide 290mcg) for the symptomatic treatment of moderate to severe Irritable Bowel Syndrome with Constipation (IBS-C)in adults.

Constella is an oral, once-daily medication. Linaclotide, the active ingredient in Constella, is a guanylate cyclase-C agonist (GCCA) with visceral analgesic and secretory activities, ...

Nice rejectes Esbriet (InterMune) as a treatment for Pulmonary Fibrosis

The National Institute for Health and Clinical Excellence (NICE) has rejected the use of Esbriet(pirfenidone), from InterMune, on the National Health Service to treat patients with idiopathic Pulmonary Fibrosis as it finds the drug is not cost effective....

Forest files cariprazine at FDA for Schizophrenia and Bipolar Disorder

Forest Laboratories, Inc., and Gedeon Richter Plc. announced that Forest has submitted a New Drug Application (NDA) to the FDA for cariprazine, a potent dopamine D3/D2 receptor partial agonist with preferential binding to D3 receptors. Cariprazine was discovered by Gedeon Richter Plc and is licensed to Forest Laboratories Inc., in the U.S. and Canada. The application for the treatment of ...

Phase III trial of GS 7977 plus RBV (Gilead Sciences) shows positive results in patients with Hepatitis C

Gilead Sciences has announced topline results from the Phase III POSITRON study of GS 7977 (sofosbuvir) plus ribavirin (RBV) in patients with genotype 2 or 3 chronic Hepatitis C who are not candidates to take interferon (IFN). The study found that 78 percent of patients (n=161/207) remained HCV RNA undetectable 12 weeks after completing therapy (SVR12). SVR12 rates were 93 ...

Phase III trial of Stivarga (Bayer HealthCare) finds positive effect in patients with GIST

A new study demonstrates that Stivarga (regorafenib), from Bayer HealthCare, was able to control GIST for nearly four months longer than placebo in patients for whom Gleevec and Sutent were no longer effective, a result that was highly significant statistically. The Phase III international trial involved 199 treatment-resistant GIST patients at 57 hospitals in 176 countries. Of the 199 patients, ...

European Commission approves Elyea (Bayer) for treatment of "wet" AMD.

Bayer HealthCare announced that Eylea (aflibercept solution for injection), also known in the scientific literature as VEGF Trap-Eye, has been approved by the European Commission for the treatment of patients with neovascular (wet) age-related macular degeneration (wet AMD) at a recommended dose of 2 milligrams (mg). Eylea treatment is initiated with one injection per month for three consecutive doses, followed ...

European Commission approves Humira (Abbott Labs) for paediatric Crohn's Disease

The European Commission has approved Humira (adalimumab) from Abbott Labs for the treatment of paediatric patients aged six to 17 years with severe active Crohn’s Disease who have failed conventional therapy, such as maintaining proper nutrition, a corticosteroid and an immunomodulator. With this approval, it becomes the first biologic treatment for these patients in more than five years....

Two Phase III studies of efinaconazole (Valeant Pharma) show positive results in patients with Onychomycosis

Positive results have been published from two pivotal, Phase III multicenter, randomized, double-blind, vehicle-controlled studies of efinaconazole, from Valeant Pharma, that were conducted in 1,655 subjects with Onychomycosis. The study's primary endpoint was the complete cure rate at Week 52, meaning the target nail showed no clinical involvement and no evidence of fungus present by both KOH testing and a ...

FDA approves 3D X- Ray for Breast Cancer

The FDA has approved the Selenia Dimensions System,from Hologic Inc., the first X-ray mammography device that provides three-dimensional (3-D) images of the breast for breast cancer screening and diagnosis. A mammogram is a safe, low-dose X-ray of the breast that is the best tool for early detection of breast cancer. However, with the limitations of conventional two-dimensional (2-D) imaging, about ...

Actelion submits Opsumit to EMA for treatment of PAH

Actelion has announced that the submission of the Marketing Authorisation Application for macitentan (Opsumit) for the treatment of patients with Pulmonary Arterial Hypertension to the EMA has been accepted. The FDA had already received the registration dossier on October 22nd 2012.

Macitentan, a novel oral dual endothelin receptor antagonist, was studied in the pivotal, long-term, event-driven Phase III outcome ...

Phase III trial succes for perindopril/amlodipine combination (Xoma) for Hypertension

Xoma Corporation has announced the 837-patient Phase III PATH trial (Perindopril Amlodipine for the Treatment of Hypertension) has demonstrated the fixed-dose combination (FDC) of perindopril arginine combined with amlodipine besylate is statistically significantly superior to either compound alone in reducing both sitting diastolic and sitting systolic blood pressure after six weeks of treatment. This FDC, containing a patent-protected proprietary form ...

Positive results from two Phase III trials of Varisolve (BTG) as Varicose Vein treatment

Data from VANISH-1 and VANISH-2, the two US pivotal Phase III trials of Varisolve (polidocanol endovenous microfoam), from BTG, show endpoints were met with all therapeutic PEM concentrations for patients with Varicose Veins, compared to placebo (p < 0.0001). In VANISH-2, eighty per cent of patients treated with PEM reported a much or moderate improvement of symptoms, as measured with ...

European Commission approves Xarelto (Bayer) for PE and treatment of recurrent Deep Vein Thrombosis

Bayer HealthCare’s oral anticoagulant Xarelto (rivaroxaban) has been approved by the European Commission (EC) for the treatment of Pulmonary Embolism (PE) and the prevention of Recurrent Deep Vein Thrombosis (DVT) and PE in adults. This approval makes rivaroxaban the only novel oral anticoagulant approved in this indication in the EU. The approval of rivaroxaban for the treatment of PE and ...

Study shows benefits of high dose treatment with HeartLight (CardioFocus) for patients with AF

New data demonstrates the benefits of high-dose laser ablation using the HeartLight endoscopic ablation system, from CardioFocus, compared to low-dose treatment in patients with Atrial Fibrillation. Using the HeartLight System, investigators in Frankfurt, Germany were able to achieve an acute pulmonary vein isolation (PVI) rate of 89% after an initial visually guided ablation circle and reported a long-term clinical success ...

Sobi files Kineret at EMA for CAPS treatment

Sobi (Swedish Orphan Biovitrium)) has filed an application for an EU Marketing Authorization with the European Medicines Agency (EMA) for Kineret (anakinra) for the indication of Cryopyrin Associated Periodic Syndromes (CAPS). The filing is based on positive safety and efficacy outcome data from a long-term treatment study in children and adults with neonatal-onset multisystem inflammatory disease (NOMID), the most severe ...

Succesful trial of Synflorix vaccine (Glaxo Smith Kline) to protect infants against Pneumococcal Disease

New results of a study suggest that a series of three or four shots of Synflorix PCV10 vaccine, from Glaxo Smith Kline, which includes three additional pneumococcal strains, should prevent over 70% of severe Pneumococcal Disease cases in children worldwide. The FinIP trial is the first European randomised study and included nearly 46 000 children younger than 19 months, randomised ...

Seroquel XR (AstraZeneca) is declared invalid by German Federal Court

The Federal Patent Court in Germany has found the formulation patent protecting Seroquel XR (quetiapine fumarate) prolonged-release tablets – marketed as Seroquel Prolong in Germany by Astra Zeneca – to be invalid. The patent was challenged by Accord Healthcare .Total sales of Seroquel XR in Germany for the ten months ended 31 October 2012 were $82 million....

ACZ 885 (Novartis) continues positively in Phase II trial for TRAPS

An ongoing Phase II, open-label, multicenter study is investigating the efficacy and safety of ACZ 885 ,from Novartis, in patients with active Tumor Necrosis Factor (TNF) Receptor-associated Periodic Syndrome (TRAPS).

Patients received ACZ 885 150 mg (or increased to 300 mg for those without complete or almost complete response by Day 8) every four weeks for four months. ...

ACZ 885 (Novartis) success in Phase II study for Familial Mediterranean Fever

In the Phase II Familial Mediterranean Fever study, 100% of patients (nine out of nine) achieved at least a 50% reduction in the frequency of disease attacks during three months of ACZ 885 treatment from Novartis. All nine patients in the trial had previously experienced at least one attack per month over three months before receiving ACZ 885, while using ...

IDX 184 and IDX 719 safety data presented by Indenix.

Idenix has announced the presentation of safety and antiviral activity results for the Company's clinical-stage Hepatitis C virus (HCV) drug candidates — IDX 719, a next-generation pan-genotypic NS5A inhibitor, and IDX 184, a nucleotide polymerase inhibitor. Idenix presented updated clinical findings from a three-day proof-of-concept study, which demonstrated that IDX 719 was well-tolerated at daily doses up to 100 ...

Lambda plus daclatasvir (BMS) combination success in Phase IIb trial for Hepatitis C

BMS has announced for the first time interim results from the global, D-LITE Phase IIb study, in which a 24-week regimen combining the investigational compound Peginterferon lambda-1a (Lambda) with the investigational direct-acting antiviral (DAA) daclatasvir (DCV) and ribavirin (RBV), achieved sustained virologic response 12 weeks post-treatment (SVR12) in 93% (13/14) of treatment-naïve, genotype 1b chronic Hepatitis C patients who achieved ...

Positive results in Phase III trials of Naloxegol (AstraZeneca) for patients with Opioid Induced Constipation

Two Phase III trials and one safety extension trial of Naloxegol (naxolol), from AstraZeneca, in patients with non-cancer related pain and Opioid Induced Constipation (OIC) indicates that Naloxegol demonstrated statistically significant results for the primary endpoint, defined as having at least three Spontaneous Bowel Movements (SBM) per week, with at least one SBM per week increase over baseline. KODIAC-04 and ...

Two year results of Certican (Novartis ) in Liver Transplant rejection confirm superiority over tacrolimus

Novartis announced new two-year results from the largest Phase III study ever in Liver Transplantation that confirmed comparable efficacy to control and superior renal function results previously seen at 12 months. The trial evaluated the introduction of Certican (everolimus) with reduced exposure tacrolimus administered twice-daily starting one month after liver transplantation versus standard-exposure tacrolimus.

At 24 months, the incidence ...

Positive topline results from study of ABT 450/r, ABT 267, ABT 333 (Abbott) for Hepatitis C

Abbott announced topline results from AVIATOR, a phase IIb study of its ABT 450/r and ABT 267 and ABT 333 regimen for the treatment of Hepatitis C (HCV). The treatment demonstrated high sustained viral response rates at 12 weeks post-treatment (SVR12) in all 8- and 12-week arms, with combinations of direct acting antivirals (DAAs) given with and without ribavirin (RBV). ...

Abraxane (Celgene) success in Phase III study of Pancreatic Cancer

In a Phase III study,(the MPACT (Metastatic Pancreatic Adenocarcinoma Clinical Trial), Abraxane (paclitaxel protein-bound particles for injectable suspension) (albumin-bound),from Celgene, in combination with gemcitabine in treatment-naïve patients with advanced Pancreatic Cancer met its primary endpoint of overall survival. In the study, Abraxane in combination with gemcitabine demonstrated a statistically significant improvement in overall survival compared to patients receiving gemcitabine ...

Positive data from Phase III study of TA 7284 (Janssen Pharmaceuticals) for patients with Type 2 Diabetes

New results show that TA 7284 (canagliflozin), from Janssen Pharma, substantially lowers blood glucose levels compared to placebo when used as add-on therapy in patients with Type 2 Diabetes who are inadequately controlled with the antihyperglycemic medications metformin and pioglitazone. Results from the Phase III study (DIA3012) showed that canagliflozin, dosed once daily at 100 mg or 300 mg in ...

RTS.S anti malaria vaccine further results in African study

Results from a pivotal, large-scale Phase III trial, published online in the New England Journal of Medicine, show that the RTS,S malaria vaccine candidate can help protect African infants against malaria. When compared to immunization with a control vaccine, infants (aged 6-12 weeks at first vaccination) vaccinated with RTS,S had one-third fewer episodes of both clinical and severe malaria and ...

NICE rejects again Javlor (Pierre Fabre) as a treatment for Bladder Cancer

NICE (National Institute of Heatlth and Clinical Excellence) has rejected again the application from Pierre Fabre for Javlor (vinflunine) as a treatment for Bladder Cancer after platinum treatment has failed. NICE considered that there was insufficient evidence of clinical effectiveness compared to best supportive care. The 302 trial evidence could not be generalised to the entire UK population. There was ...

Boston Scientific acquires Vessix Vascular and its renal denervation system for Hypertension

Boston Scientific has acquired Vessix Vascular and with it the Vessix V2 Renal Denervation System for the treatment of Hypertension.Renal denervation is a new percutaneous catheter-based procedure that disrupts renal sympathetic nerves whose hyperactivity leads to abnormally high blood pressure. The Vassix system now has CE Mark approval and is approved in Australia...

FDA Advisory Committee recommends Tresiba and Ryzodeg for Types 1 and 2 Diabetes

The FDA's Endocrinologic and Metabolic Drugs Advisory Committee has unanimously recommended that a cardiovascular outcomes trial should be conducted regarding the New Drug Applications (NDA) for Tresiba (insulin degludec )and Ryzodeg (insulin degludec/insulin aspart), and voted 8-4 in favor of approving the products with a post-approval outcomes trial commitment...

FDA award orphan status to A 4250 (Albireo) for Primary Biliary Cirrhosis and PFIC

The FDA has awarded A 4250, from Albireo, orphan-drug designation for the treatment of Progressive Familial Intrahepatic Cholestasis (PFIC)and Primary Biliary Cirrhosis (PBC). Orphan designation was granted based on an extensive preclinical data package showing that A4250 has a high potency and a minimal systemic exposure. In addition, substantial benefits were shown in an animal model of cholestasis; the predominant ...

GSK returns US rights of Horizant to Xenoport

GlaxoSmithKline (GSK) plc announced that it has reached an agreement with XenoPort, Inc., to terminate their collaboration concerning Horizant (gabapentin enacarbil) Extended-Release Tablets, a treatment for Restless legs, for which GSK had commercialisation rights and certain development rights in the United States. Under the termination and transition agreement, GSK is returning Horizant rights to XenoPort and providing certain assistance during ...

NICE will not recommend Xolair (novartis) on re-appraisal for Allergic Asthma

NICE, the National Institute for Health and Clinical Excellence, has reviewed evidence on Xolair (omalizumab) from Novartis and decided not to recommend the drug as a treatment for severe persistent Allergic Asthma in adults and children. NICE noted that clinical trials submitted included data on people whose asthma was less severe than those currently treated with Xolair and that the ...

Study of Pradaxa (Boehringer) for Atrial Fibrillation shows positive safety profile and efficacy

New data from the RELY-ABLE study have provided additional support to the safety profile and efficacy of Pradaxa (dabigatran etexilate), from Boehringer, for stroke prevention in patients with nonvalvular Atrial Fibrillation (AF) over a period in excess of 2 years. The international multi-centre RELY-ABLE study followed 5,851 patients on dabigatran etexilate for a further 28 months after completion of the ...

Study suggests probiotic Cardioviva (Micropharma) can help reduce bad cholesterol in blood

A new study suggests that a probiotic Cardioviva (lactobacillus reuteri), from Micropharma, can lower key cholesterol-bearing molecules in the blood as well as "bad" and total cholesterol in patients with high cholesterol. The study involved 127 adult patients with high cholesterol. About half the participants took L. reuteri NCIMB 30242 twice a day, while the rest were given placebo capsules. ...

Suvorexant is filed at FDA by Merck Inc., for Sleep Disorder

A New Drug Application (NDA) for suvorexant, an investigational insomnia medicine, from Merck Inc., has been accepted for standard review by the FDA. Suvorexant will be evaluated by the Controlled Substance Staff of the FDA during NDA review. If approved by the FDA, suvorexant will become available after a schedule assessment and determination has been completed by the U.S. Drug ...

European Commission rejects Uplyso( Pfizer/Protalix) for Gaucher Disease

The European Commission has rejected Uplyso (taliglucerase alfa ) for Gaucher Disease as a grant of approval would breach the Orphan drug status of Vpriv (velaglucerase alfa) from Shire which has 10 years exclusivity from August 2010....

FDA approves Signifor (Novartis) for treatment of Cushing's Disease

The FDA Endocrinologic and Metabolic Drugs Advisory Committee has voted unanimously in support of the use of Signifor (pasireotide) from Novartis, for the treatment of patients with Cushing's Disease who require medical therapeutic intervention. The recommendation was based on data from clinical trials of pasireotide, including PASPORT-CUSHINGS (PASireotide clinical trial PORTfolio - CUSHING'S disease), the largest randomized Phase III study ...

FREEDOM study finds that CABG has better outcomes than PCI in diabetic patients with Coronary Disease

The FREEDOM study of 1900 patients over 5 years was funded by the National Heart,Lung and Blood Institute and found that for patients with diabetes and advanced coronary disease, coronary bypass surgery grafting (CABG) has a better outcome than percutaneous coronary intervention (with stents) (PCI).After five years, the CABG group had a lower combined rate of strokes, heart attacks, and ...

Study of Pycnogenol (Horphag Research Ltd) shows positive results in treatment of Asthma

A new study suggests that Pycnogenol (pine bark extract), from Horphag Research Ltd, can help improve control of allergic Asthma, reducing night awakenings caused by asthma symptoms by nearly 50 percent. Asthma patients who used Pycnogenol experienced reduced dependence on inhalation corticosteroid (ICS), which is commonly administered through an inhaler, and required less visits to a doctor due to asthma ...

FDA approves Xeljanz (Pfizer) to treat Rheumatoid Arthritis

The FDA has approved Xeljanz (tofacitinib) , from Pfizer,on 6 November 2012, to treat adults with moderately to severely active Rheumatoid Arthritis (RA) who have had an inadequate response to, or who are intolerant of, methotrexate. The safety and effectiveness of Xeljanz were evaluated in seven clinical trials in adult patients with moderately to severely active RA. In all of ...

FDA approves Acessa System (Halt Medical) for treating Uterine Fibroids

The FDA has cleared Acessa, from Halt Medical, a new medical system for treating Uterine Fibroids. To ablate targeted fibroids, the Acessa System delivers monopolar radiofrequency energy to tissue through a disposable electrosurgical RF handpiece. After treatment, the fibroid is re-absorbed by the surrounding tissue. Using this laparoscopic, outpatient procedure, the physician can provide a treatment that is low risk ...

Positive results comparing programming of S-ICD and CRT-D defibrillators (Boston Scientific) in patients at risk of Cardiac Arrest

New results from the MADIT-RIT clinical trial demonstrated improved programming of Boston Scientific dual-chamber implantable cardioverter defibrillator (S-ICD) or cardiac resynchronization therapy defibrillator (CRT-D) heart devices can reduce inappropriate therapy and risk of death. MADIT-RIT is a prospective randomized three-arm trial comparing conventional programming with two alternative settings: a high-rate therapy arm and a duration-delay arm. It evaluated 1,500 primary ...

Positive results from Phase III trial of Ruconest (Santarus) in patients with Hereditary Angioedema

A pivotal Phase III clinical study to evaluate the safety and efficacy of the investigational drug Ruconest (recombinant human C1 esterase inhibitor), from Santarus, for the treatment of acute attacks of angioedema in patients with Hereditary Angioedema (HAE) met the primary endpoint of time to beginning of symptom relief. A statistically significant difference in the time to beginning of symptom ...

Positive results in Phase III study of lomitapide (Aegerion Pharmaceuticals) for Homozygous Familial Hypercholesterolemia

New results from a Phase III clinical trial of lomitapide, from Aegerion Pharmaceuticals, show it substantially and stably reduced LDL cholesterol in patients with the orphan disease Homozygous Familial Hypercholesterolemia (HoFH). Twenty-nine adult HoFH patients from across the world were enrolled, with 23 patients completing both the efficacy and the safety phases. All of the patients received lomitapide along with ...

RELAX-AF trial positive for serelaxin (Novartis) for Acute Heart Failure

RELAX-AF was a randomized, double-blind study involving 1,161 patients and was designed to compare the efficacy and safety profile of RLX030, from Novartis, to placebo in addition to standard therapy for the treatment of Acute Heart Failure (AHF). RLX 030 was given upon hospitalization in the form of an intravenous infusion (30 mcg per kg per day) for 48 ...

T-DM1 (Genentech) is filed at FDA for HER-2 positive metastatic Breast Cancer

Genentech/Roche has announced that the FDA has accepted the company's Biologics License Application (BLA) for trastuzumab emtansine (T-DM1) and granted Priority Review. Trastuzumab emtansine’s proposed indication is for the treatment of people with HER2-positive, unresectable locally advanced or metastatic Breast Cancer (mBC) who have received prior treatment with Herceptin (trastuzumab) and a taxane chemotherapy. The FDA confirmed the action date ...

AMG 134 success in GAUSS study in patients intolerant of statins

Amgen has announced positive results from the AMG 145 Phase II GAUSS study, in patients with high cholesterol who cannot tolerate statins. Reductions of up to 51 percent were observed in low density lipoprotein cholesterol (LDL-C), or "bad" cholesterol, with AMG 145 and 63 percent with the combination of AMG 145 and ezetimibe, compared to 15 percent with ezetimibe alone. ...

AMG 145 (Amgen) success in RUTHERFORD study for HeFH

Amgen has announced that treatment with AMG 145 in combination with statin therapy, with or without ezetimibe, resulted in a reduction in low density lipoprotein cholesterol (LDL-C), or "bad" cholesterol, by up to 56 percent in patients with heterozygous familial hypercholesterolemia (HeFH) in the Phase II RUTHERFORD study.

AMG 145 is an investigational fully human monoclonal antibody directed against PCSK9, ...

Phase III trial of Urocidin (Endo Pharma) for Bladder Cancer is abandoned

A Phase III clinical trial with Urocidin (mycobacterial cell wall DNA complex), from Endo Pharma, in non-muscle-invasive Bladder Cancer is being discontinued. The trial, a randomized, active-controlled, open-label, multi-center study with a blinded endpoint assessment designed to compare Urocidin with mitomycin C in the intravesical treatment of patients with BCG recurrent or refractory non-muscle-invasive Bladder Cancer, was being run by ...

Positive results in Phase III trial of OMS 302 (Omeros Corporation) in patients undergoing Cataract Surgery

In the second of two pivotal Phase III clinical trials evaluating OMS 302, from Omeros Corporation, in patients undergoing intraocular lens replacement surgery for Cataracts, OMS 302 met its co-primary endpoints by demonstrating statistically significant maintenance of intraoperative mydriasis (pupil dilation) and statistically significant reduction of pain in the early postoperative period. Mydriasis is critical to the safety and surgical ...

Epanova (Omthera Pharma) successes in EVOLVE and ESPIRIT trials for Dyslipidaemia

Omthera Pharmaceuticals, announced that Phase III results from its EVOLVE (EpanoVa fOr Lowering Very High triglyceridEs) and ESPRIT (Epanova combined with a Statin in Patients with HypertrRglycerIdemia to Reduce Non-HDL CholesTerol) clinical trials for Epanova met all primary and secondary endpoints. Highlights: • Epanova significantly lowers triglycerides (TG) and reduces Non-HDL-C, widely believed to be the most accurate predictor ...

EU approves Votubia (Novartis)for Renal Angiomyolipoma

Novartis received approval from the European Commission (EC) for Votubia (everolimus) tablets for the treatment of adult patients with renal angiomyolipoma associated with tuberous sclerosis complex (TSC) who are at risk of complications (based on factors such as tumor size or presence of aneurysm, or presence of multiple or bilateral tumors) but who do not require immediate surgery. This ...

FDA Advisory Committee recommends raxibacumab (HGS), for Anthrax

The FDA Anti-Infective Drugs Advisory Committee (AIDAC) voted 16-1, with one abstention, that animal studies conducted by Human Genome Sciences of raxibacumab, an injectable recombinant fully human monoclonal antibody that targets the protective antigen component of the lethal toxin of Bacillus anthracis, provided substantial evidence the drug, with or without antimicrobials, was reasonably likely to produce clinical benefit as ...

GALNS (BioMarin) success in Phase III study for MPS IVA

BioMarin Pharmaceutical Inc.has announced that the pivotal Phase III study of GALNS met the primary endpoint of change in six-minute walk distance compared with placebo at 24 weeks in subjects receiving weekly infusions of GALNS at the dose of 2 mg/kg (p=0.0174). MOR-004 was a randomized, double-blind, placebo-controlled study evaluating two doses of GALNS (BMN-110, N- acetylgalactosamine-6-sulfatase) for the treatment ...

Analysis suggests Neurostar TMS therapy (Neuronetics) has fewer side effects than drugs in treating Depression

A new analysis shows that magnetic stimulation of the brain using the Neurostar Transcranial Magnetic Stimulation system, from Neuronetics, can reduce symptoms of Depression yet causes little disruption to sleep or arousal behaviour, in contrast to conventional drugs. Researchers carried out a secondary analysis of 301 patients at 23 sites to compare responses to transcranial magnetic stimulation therapy and placebo ...

FDA and EU approve Sensation Plus (Maquet Cardiovascular) for patients with Heart Failure

Maquet Cardiovascular has received 510(k) clearance from the FDA and CE mark approval in the EU for its new Sensation Plus 40cc intra-aortic balloon (IAB) catheter. IAB therapy is used in patients with left ventricular failure and other cardiac conditions to augment coronary blood flow and to increase myocardial oxygen supply and decrease myocardial oxygen demand. This new larger-volume, fiber-optic ...

European Commission approves Tradjenta (Eli Lilly/Boehringer) for treatment with insulin for patients with Type 2 Diabetes

Boehringer Ingelheim and Eli Lilly and Company announced that the European Commission has approved an expanded therapeutic indication for the DPP-4 inhibitor Trajenta (linagliptin) to include use in combination with insulin in adults with Type 2 Diabetes. The approval means linagliptin is now indicated for use in combination with insulin with or without metformin, when this regimen alone, with diet ...

European Commission approves Tradjenta (Eli Lilly/Boehringer) for treatment with insulin for patients with Type 2 Diabetes

Boehringer Ingelheim and Eli Lilly and Company announced that the European Commission has approved an expanded therapeutic indication for the DPP-4 inhibitor Trajenta (linagliptin) to include use in combination with insulin in adults with Type 2 Diabetes. The approval means linagliptin is now indicated for use in combination with insulin with or without metformin, when this regimen alone, with diet ...

Study analyses role of Avastin (Roche/Genentech) in Colorectal Cancer

A recent paper that analysed the E2300 registration study of Avastin( bevacizumab) from Roche/Genentech, for Colorectal Cancer shows why Avastin has such an unpredictable effect. At least half of colorectal cancer patients, according to the study, who are given the drug derive no benefit. Patients with low levels of the VEGF 165b variant demonstrate both progression free survival and ...

Clear benefits of transcatheter aortic valve replacement for patients with Aortic Valve Disease

A study found that transcatheter aortic valve replacement (TAVR) yielded lower mortality rates after three years compared with medical therapy in patients deemed to be ineligible for conventional Aortic Valve surgery. A total of 358 patients underwent randomization at 21 centers. According to results of the PARTNER Cohort B trial, the Kaplan Meier estimated rates of death at three years ...

FDA approves Affinity Pixie Oxygenation System (Medtronic Inc) for use in Heart Surgery on children

The FDA have given 510(k) clearance for the Affinity Pixie Oxygenation System, from Medtronic Inc, for use during lifesaving open-heart (cardiopulmonary bypass) surgeries in neonates, infants and small children, including those with congenital heart defects. The Affinity Pixie Oxygenation System serves as a child’s lungs during open-heart surgery by removing carbon dioxide and adding oxygen to the child’s blood before ...

FDA grants accelerated approval for Synribo ( Cephalon/Teva) for CML

The FDA on 26 October 2012 granted accelerated approval for Synribo (omacetaxine mepesuccinate)from Cephalon/Teva to treat adults with Chronic Myelogenous Leukemia (CML), a blood and bone marrow disease.

The drug’s effectiveness in chronic phase CML was demonstrated by a reduction in the percentage of cells expressing the Philadelphia chromosome genetic mutation found in most CML patients. Fourteen out of ...

Study shows second generation drug-eluting stents are safe and effective

A study found that second-generation drug-eluting stents are safe and effective in the treatment of left main coronary artery lesions. The ISAR-LEFT MAIN 2 trial is the first and largest multicenter comparison trial between second-generation zotarolimus-eluting (ZES) and everolimus-eluting stents (EES) in invasive treatment of unprotected left main coronary artery (uLMCA) lesions.

The incidence of major adverse cardiac events (MACE) ...

Lurasidone (Takeda) filed at EMA for Schizophrenia

The European Medicines Agency (EMA) has accepted for review the marketing authorisation application (MAA) from Takeda for the oral atypical antipsychotic, lurasidone hydrochloride, for the treatment of Schizophrenia. This drug was developed by Dainippon Sumitomo and licensed to Takeda in March 2011, granting the latter exclusive commercialisation rights for lurasidone in 26 EU member states (excluding the UK), and Switzerland, ...

NICE does not recommend Colobreathe (Forest Labs) for treatment of Cystic Fibrosis infection

NICE does not recommend Colobreathe (colistimethate dry powder for inhalation)from Forest Labs as a cost effective option for treating chronic pulmonary infection caused by P. aeruginosa in people with Cystic Fibrosis. The Committee noted that there was no economic analysis pitting the product against the nebulised form of colistimethate, while results of its preferred economic analysis showed that Colobreathe was ...

NICE recommends Bronchitol (Pharmaxis) for treatment of Cystic Fibrosis

The National Institute for Health and Clinical Excellence (NICE)has issued a positive recommendation in its Final Appraisal Determination for Bronchitol (mannitol dry powder) from Pharmaxis, clearing the way for reimbursement by the National Health Service. Bronchitol is recommended for adults whose lung function is rapidly declining and who do not use inhaled mucolytics for certain reasons. Bronchitol was filed at ...

NICE recommends Tobi Podhaler (Novartis) for treatment of Cystic Fibrosis

NICE has recommended the use of Tobi Podhaler (tobramycin inhalation powder) from Novartis for the treatment of pseudomonas lung infection in Cystic Fibrosis patients aged six years and above. Tobi Podhaler may only be used in cases where treatment with the nebulised form of the drug is considered appropriate, i.e. when patients cannot have or do not respond to treatment ...

Updated results in Phase III trial of Abraxane (Celgene Oncology) for patients with Metastatic Melanoma

New results from the CA 033 Phase III trial of Abraxane (nab-paclitaxel), from Celgene Oncology, show a statistically significant improvement in progression-free survival in chemotherapy-naïve patients with Metastatic Melanoma compared to patients receiving dacarbazine chemotherapy (4.8 vs. 2.5 months, respectively (HR:0.792; 95.1% CI: 0.631, 0.992; P=0.044). An interim analysis of overall survival, the secondary endpoint, shows a trend in favour ...

Novartis files QVA 149 in EU for COPD

QVA 149 (indacaterol plus glycopyrronium bromide), an investigational drug from Novartis, for Chronic Obstructive Pulmonary Disease (COPD) has been filed for marketing authorisation with the EMA. The first five studies in the Phase III IGNITE clinical trial program for QVA 149 formed the basis of the filing. ILLUMINATE, SHINE, SPARK and BRIGHT met their respective superiority primary endpoints of FEV1 ...

PT 003 (Pearl Therapeutics) success in Phase IIB study for COPD

Pearl Therapeutics Inc. has announced the completion of a randomized, double-blind, dose-ranging Phase IIb trial of PT003, Pearl's lead investigational inhaled combination bronchodilator product for the treatment of patients with moderate-to-severe COPD. This study assessed five BID doses of PT003, in which formoterol fumarate (FF) was co-formulated with five descending doses of glycopyrrolate (GP) and administered via metered-dose inhaler (MDI). ...

Oral Treprostinal (United Therapeutics) attracts Complete Response Letter from FDA

A Complete Response Letter was received by United Therapeutics from the FDA declining to approve its new drug application (NDA) for treprostinil diethanolamine extended release tablets (oral treprostinil) for the treatment of Pulmonary Arterial Hypertension (PAH).

The FDA letter questioned the clinical importance of the 6 Minute Walk Distance (6MWD) effect size shown in the FREEDOM-M study, the ...

Positive results for Phase III trial of BAY 63-2521 (Bayer HealthCare) in patients with CTEPH

Data from the Phase III CHEST-1 trial evaluating BAY 63-2521 (riociguat), from Bayer HealthCare, in patients with inoperable Chronic Thromboembolic Pulmonary Hypertension (CTEPH) or with persistent or recurrent pulmonary hypertension (PH) after surgery showed the study met its primary endpoint by demonstrating a statistically significant improvement in the six-minute walk distance. In the CHEST-1 study, 261 patients with inoperable CTEPH ...

Positive topline results for SAR 1118 (SARcode) for treating Dry Eye Disease

Topline results from OPUS-1, a pivotal Phase III study of SAR 1118 (lifitegrast ophthalmic solution), from SARcode, for the treatment of Dry Eye Disease demonstrate the drug is superior to placebo in the improvement of inferior and total corneal staining scores from baseline to week 12. Lifitegrast also significantly improved the most commonly reported symptoms of dry eye disease in ...

Sideguard coronary stent success in Coronary Bifurcation Disease

Cappella Medical Devices Ltd a company developing solutions for the treatment of Coronary Bifurcation Disease, has announced the multicenter long term follow up results for its innovative Sideguard coronary sidebranch stent . Long term follow up data on the Sideguard stent was obtained from 399 patients from the United Kingdom, Germany, and Italy. The MACE rate was: 3.7% (30 ...

Xalkori (Pfizer) is EU approved conditionally for Non Small Cell Lung Cancer

Pfizer Inc. announced that the European Commission on 23 October 2012 has given conditional marketing authorization for Xalkori (crizotinib) in the European Union (EU) for the treatment of adults with previously treated anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC).

Similar to accelerated approvals in the United States, conditional marketing authorizations in the EU are ...

Actelion files Opsumit at FDA for treatment of PAH

Actelion has announced that it has submitted a New Drug Application (NDA) to the FDA seeking approval for macitentan Opsumit (macitentan)for the treatment of patients with Pulmonary Arterial Hypertension.

Macitentan, a novel oral dual endothelin receptor antagonist, was studied in the pivotal, long-term, event-driven Phase III outcome study, SERAPHIN, in which 742 patients suffering from pulmonary arterial hypertension ...

Dulaglutide (Eli Lilly) success in AWARD Phase III trials for Type 2 Diabetes

Eli Lilly and Company has announced positive top-line results of three completed Phase III AWARD trials for dulaglutide, an investigational, long-acting glucagon-like peptide 1 (GLP-1) analog being studied as a once-weekly treatment for Type 2 Diabetes. Primary efficacy endpoints, as measured by reduction in hemoglobin A1c (HbA1c) at the 1.5 mg dose, were met in three studies (AWARD-1, AWARD-3 ...

FDA approve ExAblate (InsighTec) to treat Pain from Bone Metastases

The FDA has approved ExAblate MRI-guided focused ultrasound, from InsighTec, as a therapy to treat Pain from bone metastases in patients who do not respond or cannot undergo radiation treatment for their pain. The ExAblate system integrates magnetic resonance imaging and high intensity focused ultrasound. FDA approval was based on the results of an international, multi-center, randomized clinical study comparing ...

FDA approves Fycompa (Eisai) as a treatment for Epilepsy

Eisai Inc. has received approval on 22 October 2012 from the FDA for the AMPA receptor antagonist Fycompa (perampanel) as an adjunctive treatment of partial-onset seizures with or without secondarily generalized seizures in patients with Epilepsy age 12 years and older.

The approval decision was based primarily on clinical data from three pivotal Phase III, global, randomized, double-blind, ...

NICE positive for Procoralan (Servier) for Heart Failure

The National Institute for Health and Clinical Excellence (NICE) has now published final draft guidance recommending Procoralan (ivabradine) from Servier Labs, as an option for treating Chronic Heart Failure, specified as NYHA class II to IVi. It has, however, stipulated that the drug should only be used in patients with systolic dysfunction, those who are in sinus rhythm, when ...

Successsful Phase III study of Actimid in Multiple Myeloma

A phase III, multi-center, randomized, open-label study (MM-003) of Actimid (pomalidomide) plus low-dose dexamethasone compared to high-dose dexamethasone in patients with relapsed and/or refractory Multiple Myeloma was reviewed by a data safety monitoring board (DSMB). The DSMB determined MM-003 met the primary endpoint of improvement in progression-free survival (PFS) at the PFS final analysis. Additionally, at the OS interim ...

Phase III trial of BAY 63-2521 (Bayer HealthCare) for PAH meets primary endpoint

The Phase III PATENT-1 Pulmonary Arterial Hypertension (PAH) trial evaluating BAY 63-2521 (riociguat), from Bayer HealthCare, in both treatment-naive patients and those pre-treated with an endothelin receptor antagonist or an oral, inhaled or subcutaneous prostanoid has met its primary endpoint. PATENT is an international program with active centers in 32 countries. It includes a randomized, double-blind, placebo-controlled trial phase (PATENT-1) ...

CHMP recommends extension of Isentress indication for HIV

The CHMP has recommended a change to the indication for Isentress (raltegravir), from Merck., which is now indicated in combination with other anti-retroviral medicinal products for the treatment of human immunodeficiency virus (HIV-1) infection in adults, adolescents, and children from the age of 2 years....

CHMP recommends Tresiba (Novo Nordisk) for treatment of Diabetes

The CHMP has made recommendation for Tresiba (insulin degludec), a new basal analogue insulin from Novo Nordisk, for the treatment of Diabetes mellitus in adults. It is introduced in a pre-filled pen in two formulations – 100 units/ml and 200 units/ml.

This is the first insulin approved in Europe at a higher strength than the EU-wide standard of 100 units/ml, ...

CHMP recommends Xarelto (Bayer) for the treatment of Pulmonary Embolism and the prevention of recurrent Deep Vein Thrombosis and Pulmonary Embolism in adults.

Bayer HealthCare’s oral anticoagulant Xarelto (rivaroxaban) has been recommended for approval by the European Committee for Medicinal Products for Human Use (CHMP) for the treatment of pulmonary embolism (PE) and the prevention of recurrent deep vein thrombosis (DVT) and PE in adults. The decision of the European Commission on the approval is expected before the year-end. The CHMP recommendation to ...

CHMP recommends Amyvid (Eli Lilly) for Alzheimers investigations

The Committee for Medicinal Products for Human Use (CHMP) has recommended marketing authorisation for Amyvid (florbetapir 18F) from Eli Lilly, as a diagnostic agent in patients who are being evaluated for Alzheimer’s disease (AD) and other causes of cognitive decline. Amyvid is a radiopharmaceutical agent used in positron emission tomography (PET) imaging in the brains of adults. It can ...

CHMP recommends Betmiga (Astellas) for patients with Overactive Bladder

The CHMP has adopted a positive opinion, recommending the granting of a marketing authorisation for Betmiga (mirabegron), from Astellas, for the symptomatic treatment of urgency, increased micturition frequency and/or urgency incontinence as may occur in adult patients with Overactive Bladder (OAB) syndrome. If approved, mirabegron will be the first in a new class of OAB treatment, offering healthcare professionals an ...

CHMP recommends Humira (Abbott) for paediatric patients with Crohn's Disease

The CHMP has adopted a positive opinion for Humira (adalimumab), from Abbott Labs, for the treatment of paediatric patients aged six to 17 years with severely active Crohn's Disease (CD) who failed, are intolerant to or have contraindications to conventional therapy. Following the CHMP's positive opinion, a final decision from the European Commission is anticipated in the next few months. ...

CHMP recommends Krystexxa (Savient Pharma) for treatment of Gout

On 18 October 2012, the CHMP adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Krystexxa, 8 mg/ml, concentrate from Savient Pharma, for solution for infusion intended for the treatment of severe debilitating chronic tophaceous Gout in adult patients who may also have erosive joint involvement and who have failed to normalize serum uric ...

CHMP recommends Ryzodeg combination (Novo Nordisk) for treatment of Diabetes

On 18 October 2012, the CHMP adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Ryzodeg, 100 units/mL, solution for injection from Novo Bordisk, intended for the treatment of diabetes mellitus. The active substances of Ryzodeg are insulin degludec and insulin aspart, a soluble insulin product consisting of the basal insulin degludec and ...

CHMP recommends Ryzodeg(Novo Nordisk) for treatment of Diabetes Mellitus

On 18 October 2012 the CHMP adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Ryzodeg (insulin degludec) from Novo Nordisk, 100 units/ml and 200 units/ml, solution for injection, intended for the treatment of Diabetes Mellitus. The benefits with Ryzodeg are its ability to lower blood glucose levels and a lower risk of nocturnal ...

CHMP rejects Acrescent (Lundbeck)/Balaxur (Merz) as a treatment for Alzheimers Disease

On 18 October 2012, the CHMP adopted a negative opinion, recommending the refusal of the marketing authorisation for the combination medicinal product memantine hydrochloride and donepezil hydrochloride, known as Acrescent from Lundbeck and Balaxur from Merz, intended for the treatment of moderate to moderately severe Alzheimer’s disease in patients who are already taking memantine and donepezil.

The Committee was ...

CHMP rejects Qsiva (Vivus Inc.,) as a treatment for Obesity

On 18 October 2012, the CHMP adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Qsiva (phentermine plus topiramate) from Vivus Inc., intended for the treatment of Obesity.

The CHMP noted that the main studies showed clinically relevant weight loss following treatment with Qsiva but had concerns about the medicine’s long-term effects on the ...

Sanofi Pasteur has submitted Hexaxim vaccine to EMA for approval in Europe

The Hexaxim vaccine (DTaP-IPV-Hib-HepB) has been submitted by Sanofi Pasteur MSD to the EMA for approval to licence within the European Union. Upon approval the company says it will commercialise it in its European territories under its own brand name. The new hexavalent vaccine, developed by Sanofi Pasteur, is the only fully liquid, ready to use 6-in-1 vaccine to protect ...

Bardoxolone (Reata/Abbott) Phase III trial terminated for Chronic Kidney Disease

Reata Pharma, in consultation with the BEACON Steering Committee, has decided to terminate the Phase III BEACON trial of bardoxolone methyl in patients with stage 4 Chronic Kidney Disease and Type 2 Diabetes. This decision was made based upon a recommendation of the Independent Data Monitoring Committee (IDMC) to stop the trial "for safety concerns due to excess serious adverse ...

FDA Advisory Committee recommends Kynamro for treatment of Homozygous Familial Hypercholesterolemia

Genzyme, a Sanofi company and Isis Pharmaceuticals have announced that the Endocrinologic and Metabolic Drugs Advisory Committee of the FDA voted 9 to 6 that Genzyme had provided sufficient efficacy and safety data to support the marketing of Kynamro (mipomersen sodium) for the treatment of patients with Homozygous Familial Hypercholesterolemia (HoFH). Many people with HoFH have aggressive cardiovascular disease beginning ...

FDA approve Coflex (Paradigm Spinal) to treat moderate to severe Stenosis

The FDA has granted a Premarket Approval Order for Coflex, a motion preserving interlaminar stabilization device from Paradigm Spine, for the treatment of moderate To severe Stenosis with or without back pain. The approval is based on comprehensive Level 1 comparative effectiveness study for the treatment of spinal Stenosis. The six year clinical trial demonstrates Coflex provides better or equivalent ...

FDA extend approval of Alimta (Eli Lilly) for maintenance treatment in NSCLC

The FDA has announced that patients may receive Alimta (pemetrexed for injection), from Eli Lilly, as a maintenance therapy following first-line Alimta plus cisplatin for locally advanced or metastatic nonsquamous Non-Small Cell Lung Cancer (NS NSCLC). The FDA approved the label inclusion of Phase III data that demonstrated progression-free and overall survival advantages in the continuation maintenance setting for these ...

No significant evidence that cranberry juice can prevent UTIs

A Cochrane Library review finds that cranberries may not be effective in treating Urinary Tract Infections. Some evidence shows that cranberry juice may decrease the number of symptomatic UTIs over a 12 month period, particularly for women with recurrent UTIs. However the addition of 14 further studies suggests that cranberry juice is less effective than previously indicated. Although some of ...

FDA Advisory Committee recommends lomitapide (Aegerion Pharma) for HoFH

In a 13-2 vote, the FDA Endocrinologic and Metabolic Drugs Advisory considered that Aegerion Pharma provided sufficient efficacy and safety data to support marketing of lomitapide for Homozygous Familial Hypercholesterolemia (HoFH), despite its association with liver toxicity. The application was based on a single 18-month open-label, single-arm pivotal Phase III trial, which only enrolled 29 patients with HoFH, with supportive ...

FDA approves Jetrea (Thrombogenics NV) for the treatment of Vitreomacular Adhesion

The FDA has approved Jetrea (ocriplasmin), from Thrombogenics NV, in the US for the treatment of symptomatic Vitreomacular Adhesion (VMA), a progressive sight threatening condition. Jetrea is the first pharmacological agent to be approved for this indication. The approval was based on the data from ThromboGenics' Phase III program where Jetrea was shown to be superior to placebo for the ...

Inlyta (Pfizer) not superior to Nexavar in Renal Cell Carcinoma trial

A Phase III study AGILE 1051, of Inlyta (axitinib) from Pfizer, did not meet its primary endpoint of demonstrating statistically significantly longer progression-free survival (PFS), versus Nexavar (sorafenib), in treatment-naïve patients with advanced Renal Cell Carcinoma (RCC).

A preliminary review of the data showed that overall the median PFS for Inlyta exceeded the median PFS for sorafenib, ...

Allergan to co market Levadex in USA

Upon FDA approval, Allergan will commit its existing U.S. sales force currently pushing BOTOX for Chronic Migraine to headache specialists with MAP Pharmaceuticals' field sales force targeting neurologists and pain specialists doubling the sales opportunity. Levadex for Acute Migraine patients and Botox for Chronic Migraine patients....

Complete Response Letter from FDA for Levadex (MAP Pharma) for Migraine

The FDA has issued a Complete Response Letter to MAP Pharma to its new drug application for Levadex (dihydroergotamine meyslate) inhalation aerosol for the acute treatment of Migraine. The FDA has raised issues on chemistry, manufacturing and controls but has not required a new trial Allergan will co-market Levadex in the USA....

FDA Advisory Committee recommends Gattex (NPS Pharma) for Short Bowel Syndrome

The FDA Gastrointestinal Drugs Advisory Committee voted unanimously to recommend approval of Gattex (teduglutide) from NPS Pharma. It voted 12-0 that the drug delivered meaningful benefits as a treatment for Short Bowel Syndrome (SBS) and that the benefits of the drug outweigh its potential risks.The drug was approved in September 2012 in the EU for Nycomed/Takeda as Revestive...

FDA approve Aptima HPV Assay (Hologic) for detecting Human Papillomavirus

The FDA has approved the Aptima HPV 16 18/45 Genotype Assay, from Hologic, for use on its Tigris instrument system. It is the first FDA-approved test for genotyping human papillomavirus (HPV) types 16, 18 and/or 45, which are associated with approximately 80% of all invasive Cervical Cancers worldwide. The test is specifically approved for use adjunctively with the Aptima HPV ...

Levadex is filed at the FDA for Migraine

MAP Pharmaceuticals has submitted a New Drug Application (NDA) to the FDA for Levadex orally inhaled migraine drug for the potential acute treatment of migraine in adults.The submission is based on the FREEDOM-301 study see Headache. 2011 Apr;51(4):507-17. doi: 10.1111/j.1526-4610.2011.01869.x. MAP0004, orally inhaled DHE: a randomized, controlled study in the acute treatment of migraine. Aurora SK, Silberstein SD, Kori SH, ...

MAP Pharma re-submits Levadex to the FDA for treatment of Migraine

MAP Pharmaceuticals, has announced that it has re-submitted its New Drug Application (NDA) to the FDA for Levadex, orally inhaled migraine drug ,for the potential acute treatment of Migraine in adults. MAP Pharmaceuticals has entered into a collaboration agreement with Allergan to co-promote Levadex to neurologists and pain specialists in the U.S. and Canada. MAP Pharmaceuticals retains all rights to ...

Chantix/Champix (Pfizer) Smoking Cessation study in depressed patients

Pfizer announced the completion of a double-blind, placebo-controlled, randomized clinical trial designed to assess the efficacy and safety of Chantix/Champix (varenicline) 1 mg BID in comparison to placebo for Smoking Cessation in patients with a past or present diagnosis of Major Depressive Disorder (MDD). The study met its primary and secondary efficacy endpoints. Subjects in the varenicline group had ...

Positive results in MOVE2 study of Sativex (Almirall) for patients with Multiple Sclerosis spasticity

Results of the MOVE2 study showed that one month's treatment with Sativex (delta-9-tetrahydrocannabinol and cannabidiol), from Almirall, reduces moderate to severe Multiple Sclerosis spasticity (MSS) by 20% or more in 4 out of 10 patients previously unresponsive to conventional therapies. After three months, the improvement observed was 30% or more. Overall, 55% of the initial patients were eligible for continuing ...

Ramucirumab (Eli LillY) success iN Phase III trial for Gastric Cancer

The REGARD trial, a Phase III study of ramucirumab (IMC-1121B) from Eli Lilly, in patients with metastatic Gastric Cancer, met its primary endpoint of improved overall survival and also showed prolonged progression-free survival. This trial is the first Phase III data read-out for ramucirumab. The REGARD trial compared ramucirumab and best supportive care to placebo and best supportive care as ...

Turoctocog alfa (Novo Nordisk) filed for Haemophilia in US and EU

Novo Nordisk announced the submission of the regulatory application for turoctocog alfa (NN7008) to the European Medicines Agency (EMA) and the FDA. Turoctocog alfa is a third-generation recombinant coagulation factor VIII intended for prevention and treatment of bleeding in people with haemophilia A.

The decision to apply for marketing authorisation for turoctocog alfa is based upon the results ...

ABT 450/r , ABT 267, ABT 333 combination in Hepatitis C

Abbott has announced initial results from "AVIATOR," a phase IIb study of its interferon-free, investigational regimen for the treatment of Hepatitis C (HCV). Initial results show sustained virological response at 12 weeks post treatment (SVR12) in 99 percent of treatment-naïve (n=77) and 93 percent of null responders (n=41) for genotype 1 (GT1) HCV patients taking a combination of ABT-450/r, ...

Phase II success for odanacatib (Merck Inc.) for Post Menopausal Osteoporosis

Merck Inc., has announced results from a Phase II trial for odanacatib, an investigational cathepsin K (cat-K) inhibitor in development for the treatment of Osteoporosis in post-menopausal women. The results were presented at the 34th Annual Meeting of the American Society for Bone and Mineral Research.

In the study, treatment with odanacatib (compared to placebo) significantly increased Bone ...

FDA approves Abraxane (Celgene Oncology) for NSCLC

The FDA has on 11 October 2012 approved Abraxane (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) from Celgene Oncology, for the first-line treatment of locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC), in combination with carboplatin, in patients who are not candidates for curative surgery or radiation therapy.

The Abraxane sNDA approval is based upon the results ...

Novartis to discontinue development of long acting Fanapt for Schizophrenia

Novartis Pharma AG is discontinuing development of a long-acting injectable version of Fanapt (iloperidone) reported Vanda Pharmaceuticals in a securities filing. Novartis has marketed Fanapt, which is Vanda’s lead product, since 2010. Novartis has exclusive rights to develop and commercialize other formulations of Fanapt in the USA and Canada....

New global study to assess 3 drugs to prevent early-onset Alzheimer's Disease

A new clinical study will examine 3 drugs to determine whether they can prevent early-onset Alzheimer’s disease. The drugs chosen for the study which will take place at Washington University in St. Louis, are R1450 (gantenerumab), from Roche and LY 2062430 (solanezumab), from Eli Lilly and Co. R1450 is currently in a Phase III trial known as SCarlet RoAD, started ...

Nypta (Zeltia/Noscira) fails Alzheimers Disease study

Zeltia/ Noscira announces that the primary cognitive endpoint and two of the secondary endpoints were not met in the 26-week ARGO Phase IIb trial involving Nypta (tideglusib). This study evaluated the efficacy of tideglusib versus placebo plus standard of care for the treatment of mild-to-moderate Alzheimers Disease. No decision regarding future development has yet been taken as Zeltia says pending ...

Phase III results for ALO-02 (Pfizer) for moderate to severe Pain

Pfizer Inc. has announced top-line results from a Phase III open-label long-term safety study of investigational agent ALO-02 (oxycodone hydrochloride and naltrexone hydrochloride extended-release capsules) in patients with moderate-to-severe chronic, non-cancer pain. The primary objective of the study was to evaluate the safety of ALO-02 administered for up to 12 months. The study showed that the adverse event profile was ...

Positive results in three studies of Gilenya (Novartis) for patients with Multiple Sclerosis

Three new studies of Gilenya (fingolimod), from Novartis, reinforce the generally early and sustained efficacy benefit and long-term safety profile that the drug demonstrates in patients with Multiple Sclerosis. A new post hoc analysis of two Phase III studies (FREEDOMS and FREEDOMS II) showed that patients receiving the drug saw significant benefits on brain volume loss and relapse-related outcomes compared ...

EU approves subcutaneous formulation of Orencia (BMS) for moderate to severe Rheumatoid Arthritis

The European Commission has granted marketing authorization for the subcutaneous formulation of Orencia (abatacept), from BMS, in combination with methotrexate (MTX), for the treatment of adults with moderate to severe active Rheumatoid Arthritis (RA). The drug was previously approved for intravenous delivery so this extends the choice of administration route for patients and doctors. Approval of the subcutaneous formulation of ...

FDA approves Simplexa Flu A/B & RSV Direct test (Focus Diagnostics) to detect Influenza

The FDA has provided 510(k) clearance and CLIA moderate-complexity categorization to the Simplexa Flu A/B & RSV Direct test, from Focus Diagnostics, on the 3M Integrated Cycler. The new test aids in the qualitative detection and differentiation of RNA of Influenza A and B viruses and respiratory syncytial virus (RSV), common causes of respiratory illness. The Simplexa Flu A/B & ...

NICE recommends Lucentis (Novartis) for Diabetic Macular Oedema

NICE will now recommend Lucentis (ranibizumab) from Novartis for the treatment of Diabetic Macular Oedema. This is a change from previous draft guidance, which recommended against using the drug for this condition, The new decision is made after after Novartis agreed to drop the price of its drug.

In draft guidance, Lucentis is now recommended as an option ...

Positive data from Phase III trial of Serada (Depomed Inc) to manage Menopausal hot flashes

New data shows that Serada (gabapentin GR), from Depomed Inc, may help manage Menopausal hot flashes. The BREEZE 3 study included 600 menopausal women who were treated with either Serada or placebo for 24 weeks. The trial showed that Serada significantly reduced the average frequency of hot flashes at 4 weeks (-1.69 vs. placebo) and at 12 weeks (-1.14 vs. ...

Positive results from study of Genesis Neurostimulator (St Jude Medical) in patients with Migraine

Results from a large-scale study of peripheral nerve stimulation (PNS) of the occipital nerves using the Genesis neurostimulation system, from St Jude Medical, in patients suffering from chronic Migraine show a significant reduction in pain, headache days and migraine-related disability. Conducted at 15 medical centers in the US, the study followed 157 participants who, on average, suffered from headache approximately ...

Study shows safety and efficacy of Hizentra (CSL Behring) for treating Immunodeficiency

A new study conducted in Japan supports the previously demonstrated safety and efficacy of Hizentra (Immune Globulin Subcutaneous [Human]), from CSL Behring, for the treatment of primary Immunodeficiency (PID). The Phase III study, conducted in patients who converted from intravenous immunoglobulin (IVIG) treatment, found that a dose-equivalent switch to Hizentra therapy maintained serum IgG (immunoglobulin) at a similar level of ...

Eteplirsen (Sarepta Therapeutics)success in extension trial for Duchenne Muscular Dystrophy

Sarepta Therapeutics has announced that treatment with its lead exon-skipping compound, eteplirsen, met the primary efficacy endpoint, increase in novel dystrophin, and achieved a significant clinical benefit on the primary clinical outcome, the 6-minute walk test (6MWT) over the placebo/delayed treatment cohort in a Phase IIb extension trial in Duchenne Muscular Dystrophy (DMD patients.

Eteplirsen administered once weekly at either ...

MK 3103 (Merck Inc.) success in Phase IIb study for Type 2 Diabetes

Merck Inc., has announced Phase IIb data for MK-3102, the company's investigational once-weekly DPP-4 inhibitor in development for the treatment of Type 2 Diabetes. MK-3102 significantly lowered blood sugar in this 12-week study compared with placebo, with an incidence of symptomatic hypoglycemia that was similar to placebo, in patients with Type 2 Diabetes. The Phase IIb study is a ...

CANVAS study of canagliflozin Janssen) in Type 2 Diabetes sub study

CANVAS study, also known as DIA3008, is a prospective, double blind, placebo-controlled trial designed to evaluate the efficacy, tolerability and cardiovascular safety of canagliflozin, a SGLT-2 inhibitor from Janssen Pharma, in 4,330 adult patients with Type 2 Diabetes who are considered at elevated risk for cardiovascular disease.An 18-week sub-study was made of 1,718 patients enrolled in CANVAS who were receiving ...

Tresiba (Novo Nordisk) superior to Lantus in lowering hypoglycaemia in Type 2 Diabetes patients

New data presented at the Annual Meeting of the European Association for the Study of Diabetes (EASD) show that patients with Type 2 Diabetes starting insulin therapy had a 43% lower rate of night-time hypoglycaemia when using Tresiba ( insulin degludec) from Novo Nordisk, compared with those using insulin glargine (0.27 [insulin degludec] versus 0.46 [insulin glargine] episodes per patient ...

Abraxane (Celgene Oncology) success in Phase II study for Metastatic Melanoma

A Phase III, randomized, international study (CA033) reported for Abraxane (paclitaxel protein-bound particles for injectable suspension) (albumin-bound), from Celgene Oncology, in chemotherapy-naïve patients with Metastatic Melanoma. In the study, the primary endpoint was met with patients receiving Abraxane demonstrating a statistically significant improvement in progression-free survival compared to patients receiving dacarbazine (DTIC) chemotherapy. The safety profile of Abraxane observed in ...

Aquacell Ag (Convatec) surgical cover success reported in JAMA

A new study looking at infections following joint replacement surgery finds a 78 percent decrease in joint infections when Aquacell Ag SURGICAL cover dressing from ConvaTec was used. The study found that the infection rate for total joint replacement patients dropped to 0.4 percent when Aquacell Ag SURGICAL cover dressing was used as compared to 1.8 percent when gauze ...

ARQ 197 Phase III trial MARQUEE for NSCLC is stopped

ArQule, Inc. and Daiichi Sankyo, Co., Ltd. have announced that the independent Data Monitoring Committee (DMC) of the Phase III MARQUEE (Met inhibitor ARQ 197 plus Erlotinib vs Erlotinib plus placebo in NSCLC) trial recommended the study be stopped early following a planned interim analysis, when they concluded that the study would not meet its primary endpoint of improved overall ...

Botox (Allergan) approved by MHRA in UK for Urinary Incontinence

The Medicines and Healthcare products Regulatory Agency (MHRA)in the UK has given Botox (botulinum toxin type A) approval for managing Urinary Incontinence caused by neurogenic detrusor overactivity(NDO) due to subcervical spinal cord injury (SCI; traumatic or non-traumatic) or multiple sclerosis (MS), but only if treatment with anticholinergics does not work. Recently published NICE Guidelines recommend the use of botulinum toxin ...

FDA approves Quillivant XR (Next Wave) for ADHD

The FDA has approved Quillivant XR (methylphenidate hydrochloride) from Next Wave Pharma for extended-release oral suspension for treatment of Attention Deficit Hyperactivity Disorder (ADHD). Quillivant XR is the first once-daily, extended-release liquid methylphenidate available for patients with ADHD.The drug will be launched early in 2013....

Phase III success for eliglustat tartrate (Sanofi/Genzyme) in Gaucher Disease

ENGAGE, the first Phase III trial of the investigational oral therapy, eliglustat tartrate,from Sanofi/Genzyme, in previously untreated patients with Gaucher disease type 1, met its primary endpoint. Patients treated with eliglustat tartrate had a statistically significant improvement in spleen size at nine months, compared with placebo. Spleen volumes in eliglustat tartrate treated patients decreased from baseline by a mean of ...

Sub Analysis of Eliquis (BMS/Pfizer)in ARISTOTLE trial show consistent reductions in Stroke and bleeding risk

The reductions in stroke or systemic embolism, major bleeding and mortality demonstrated with Eliquis (apixaban) from BMS/Pfizer ,compared to warfarin in the ARISTOTLE trial were consistent across a wide range of stroke and bleeding risk scores in patients with nonvalvular atrial fibrillation. These results of a subanalysis from the ARISTOTLE trial were published today in The Lancet.The subanalysis demonstrated ...

Updated survival results of EMILIA study for T-DM1 for metastatic Breast Cancer

Genentech has announced updated survival results from the Phase III EMILIA study, which showed that people with previously treated HER2-positive metastatic Breast Cancer (mBC) survived significantly longer (overall survival, a co-primary endpoint) when treated with trastuzumab emtansine (T-DM1) compared to those who received the combination of lapatinib and Xeloda (capecitabine). Results showed the risk of death was reduced by 32 ...

Absorb, the bioresorbable vascular scaffold (Abbott Vascular) available in EU, Latin America and Asia

Abbott has announced that Absorb, the world's first drug eluting bioresorbable vascular scaffold (BVS), is now widely available across Europe and parts of Asia Pacific and Latin America. Absorb is a first-of-its-kind device for the treatment of Coronary Artery Disease (CAD). It works by restoring blood flow to the heart similar to a metallic stent, but then dissolves into the ...

EU approval for Seebri Breezhaler (Novartis) for COPD

Novartis announced that the European Commission has approved Seebri Breezhaler (glycopyrronium bromide) 44 mcg delivered dose (equivalent to 50 mcg glycopyrronium measured dose per capsule), as a once-daily inhaled maintenance bronchodilator treatment to relieve symptoms in adult patients with Chronic Obstructive Pulmonary Disease (COPD). This follows the September 28 approval of once-daily Seebri (glycopyrronium bromide) Inhalation Capsules 50 mcg in ...

EU approves subcutaneous Velcade (Janssen) for treatment of Multiple Myeloma

The EC has approved the subcutaneous version of Velcade (bortezomib) from J&J Janssen Cilag for Multiple Myeloma. Subcutaneous bortezomib has fewer side effects and offers greater convenience for patients, with similar efficacy compared to intravenous bortezomib....

Positive results for Xalkori (Pfizer) in treatment of patients with ALK-positive Lung Cancer

The results of a new phase III trial show that Xalkori (crizotinib), from Pfizer, is a more effective treatment than standard chemotherapy for patients with advanced, ALK-positive Lung Cancer. The current global randomized phase III study compared the efficacy and safety of crizotinib with standard chemotherapy with pemetrexed or docetaxel, in 347 patients with ALK-positive lung cancer who had already ...

Votrient (GSK) is non inferior to Sutent ( Pfizer) in COMPRAZ study for Renal Cell Carcinoma

GSK announced that the pivotal Phase III study COMPARZ has met its primary endpoint. In the open-label, head-to-head study, Votrient (pazopanib) from GSK demonstrated non-inferiority to Sutent (sunitinib) from Pfizer in terms of progression free survival. Patients in the study were treated for advanced Renal Cell Carcinoma (mRCC) with a component of clear cell histology and had received no prior ...

FDA approves Aerospan (Acton Pharma) for Asthma

Acton Pharmaceuticals, Inc. has announced that the FDA has approved the sNDA (Supplemental New Drug Application) for Aerospan (flunisolide HFA, 80 mcg) Inhalation Aerosol, a hydrofluoroalkane (HFA) orally inhaled corticosteroid indicated for the maintenance treatment of Asthma as a prophylactic therapy in adult and pediatric patients 6 years of age and older. With this approval, Acton is now planning ...

Aveo files tivozanib at FDA for treatment of Renal Cell Carcinoma

AVEO Oncology and Astellas Pharma Inc. have announced that Aveo has submitted a New Drug Application (NDA) to the FDA seeking approval for tivozanib in patients with advanced Renal Cell Carcinoma (RCC). Tivozanib is designed to target the vascular endothelial growth factor (VEGF) pathway, a clinically validated target in RCC and other solid tumors. The NDA submission is based on ...

FDA approve Humira (Abbott) for patients with moderately to severely active Ulcerative Colitis

The FDA has approved Humira (adalimumab), from Abbott, for inducing and sustaining clinical remission in adult patients with moderately to severely active Ulcerative Colitis (UC) when certain other medicines have not worked well enough. Abbott's submission was supported by results from two Phase III studies, ULTRA 1, an 8-week study, and ULTRA 2, a 52-week study, both of which enrolled ...

FDA approve S-ICD (Boston Scientific) for sudden Cardiac Arrest

The FDA had given approval for the S-ICD System (Boston Scientific), making it the first commercially available subcutaneous implantable defibrillator for the treatment of patients at risk for sudden Cardiac Arrest. FDA approval of the S-ICD System was based on data from a 330-patient, prospective, non-randomized, multicenter clinical study, which evaluated the safety and effectiveness of the system in patients ...

FDA approves Humira (Abbott) for patients with moderately to severely active Ulcerative Colitis

The FDA has approved Humira (adalimumab), from Abbott, for inducing and sustaining clinical remission in adult patients with moderately to severely active Ulcerative Colitis (UC) when certain other medicines have not worked well enough. Abbott's submission was supported by results from two Phase III studies, ULTRA 1, an 8-week study, and ULTRA 2, a 52-week study, both of which enrolled ...

FDA approves new sNDA for Sorilux (Stiefel/GSK) to treat Plaque Psoriasis of the scalp

The FDA has approved a supplemental New Drug Application for Sorilux (calcipotriene) Foam, from Stiefel/GSK. The sNDA expands the indication for Sorilux Foam to include the topical treatment of Plaque Psoriasis of the scalp in patients aged 18 years and older. It is not known if the product is safe and effective in people under 18 years old. The treatment ...

New quality-of-life data presented for Tomtovok (Boehringer) treated patients with NSCLC

Boehringer has released new results on the secondary endpoints of LUX-Lung 3, a Phase III trial of Tomtovok (afatinib) compared to chemotherapy (pemetrexed/cisplatin) in patients with epidermal growth factor receptor (EGFR) mutation-positive advanced Non-Small Cell Lung Cancer (NSCLC). Three lung cancer symptoms – cough, dyspnea (shortness of breath), and pain – were analyzed and results showed that a higher proportion ...

Novo Nordisk cancels further development of vatreptacog alfa as a treatment for Diabetes

Novo Nordisk has announced the decision to discontinue the development of vatreptacog alfa, a fast-acting recombinant factor VIIa analogue for haemophilia patients with inhibitors. The decision follows analysis of the data from the phase IIIa trial adeptTM 2. A few patients in the trial had developed anti-drug antibodies to vatreptacog alfa, one patient with a potentially neutralising effect....

Positive results from study of delamanid (Otsuka) for patients with MDR-TB

Results from an observational study evaluating delamanid, from Otsuka, have found that the treatment can improve outcomes and reduce mortality among patients with both multi-drug resistant Tuberculosis MDR-TB and extensively drug-resistant Tuberculosis (XDR-TB). A previous trial had evaluated the effectiveness of 2 months treatment but the new study followed the same patients for a further 24 months of treatment.

The ...

Vercise DBS system receives CE Mark for Parkinsons Disease

Boston Scientific Corporation has received CE Mark approval for use of its Vercise Deep Brain Stimulation (DBS) System for the treatment of Parkinson's disease. The Vercise DBS System is the first and only commercially available DBS system to incorporate multiple independent current control, which is designed to selectively stimulate targeted areas in the brain. This system is an innovative technology ...

EU approval for Dacogen (Janssen Cilag) for treatment of Acute Myeloid Leukemia

Astex Pharmaceuticals has announced that Janssen-Cilag International NV was notified that the European Commission has approved the marketing authorization for Dacogen (decitabine) for the treatment of adult patients (age 65 years and above) with newly diagnosed de novo or secondary Acute Myeloid Leukemia (AML), according to the World Health Organization (WHO) classification, who are not candidates for standard induction ...

Belinostat (TopoTarget/Spectrum) success in BELIEF study for PTCL

The pivotal BELIEF trial (PXD101-CLN-19) evaluating the efficacy and safety of belinostat from Topo Target A/S for the treatment of patients with relapsed/refractory Peripheral T-Cell Lymphoma (PTCL) met its primary endpoint. A Special Protocol Assessment agreement with the FDA requires the BELIEF trial to reach an objective response rate (ORR) of at least 20% and this objective was met. Data ...

Breo(GSK/Theravance)combination filed at FDA for COPD

GSK and Theravance, Inc. announced that the New Drug Application (NDA) for the once-daily investigational medicine, Breo (US)/Relvar (EU) (fluticasone furoate “FF”/vilanterol “VI” (FF/VI)) for patients with Chronic Obstructive Pulmonary Disease (COPD), has been accepted by the FDA indicating that the application is sufficiently complete to permit a substantive review. The Prescription Drug User Fee Act (PDUFA) goal date has ...

FDA approves Stivarga (Bayer/Onyx Pharma) for metastatic Colorectal Cancer

The FDA has on 27th September 2012 approved Stivarga (regorafenib) from Bayer HealthCare and Onyx Pharma for the treatment of patients with metastatic Colorectal Cancer (mCRC) who have been previously treated with currently available therapies (including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if KRAS wild type, an anti-EGFR therapy). The approval of Stivarga is based on results ...

First clinical study using lonafarnib (Merck Inc.) for treatment of Progeria

Results of the first-ever clinical drug trial using lonafarnib from Merck Inc., for children with Progeria, demonstrate the efficacy of a farnesyltransferase inhibitor (FTI), a drug originally developed to treat cancer. Twenty-eight children from sixteen countries participated in the two-and-a-half year drug trial, representing 75 percent of known Progeria cases worldwide at the time the trial began. Of those, 26 ...

Generic Diovan HCT launched in USA

The US patent on Diovan (valsartan) and the combination product Diovan HCT (valsartan plus the diuretic hydrochlorothiazide) from Novartis has expired. Mylan has launched its generic version of Diovan HCT and Sandoz (the genetics division of Novartis) has launched an authorised generic version of Diovan HCT. No generic version of Diovan monotherapy is yet available in the US....

Levomilnacipran (Forest Labs/Pierre Fabre) filed at FDA for Major Depressive Disorder

Forest Laboratories, Inc. and Pierre Fabre Laboratories announced that Forest has submitted a New Drug Application (NDA) to the FDA for levomilnacipran, a serotonin norepinephrine reuptake inhibitor for the treatment of Major Depressive Disorder (MDD) in adults. Levomilnacipran was discovered by Pierre Fabre and jointly developed by Forest Laboratories and Pierre Fabre, under a licensing agreement in the U.S. and ...

Merck returns all rights to vernakalant to Cardiome Pharma for Atrial Fibrillation

Merck & Co has returned the global marketing and development rights to Cardiome Pharma Corporation for both the intravenous and oral formulations for the anti-arrhythmic , Brinavess (vernakalant). Merck has been marketing the intravenous form of the drug, as Brinavess, in the European Union and Latin America for the rapid conversion of recent onset Atrial Fibrillation and planned to launch ...

Novartis reports on Phase II study of AIN 457 in Plaque Psoriasis

Novartis announced Phase II data showing AIN 457 (secukinumab) may significantly improve moderate-to-severe Plaque Psoriasis on the hands, feet and nails when used every week for the first month of treatment, compared to placebo. Additional analysis on patients with moderate-to-severe Plaque Psoriasis also showed that AIN 457 may successfully improve quality of life by Week 12 in the study. The ...

Successful Phase III trial for rFIXFc (Biogen/SOBI) for Haemophilia

Top-line results from B-LONG, a Phase III 123-patient study of the long-lasting recombinant Factor IX Fc fusion protein (rFIXFc), from Biogen IDEC and SOBI, showed that the treatment was effective in the control and prevention of bleeding, routine prophylaxis and perioperative management. Indeed, one injection of rFIXFc controlled 90.4% of bleeding episodes and the treatment was well-tolerated.

Biogen and SOBI ...

FDA expand approval for Healicoil PK (Smith&Nephew) for Joint Repairs

Smith & Nephew has received FDA clearance to expand the indications within the hip for its Healicoil PK suture anchor and Osteoraptor suture anchor. Indications for the Healicoil PK Suture Anchor have been expanded to include abductor repair while those for the Osteoraptor Suture Anchor now include labral reconstruction. Healicoil PK suture anchor differs from conventional solid-core implants by eliminating ...

Thalomid (Celgene) successful treatment of cough associated with IPF

On September 18, 2012, a new study published in the Annals of Internal Medicine found thalidomide (Thalomid) from Celgene was effective in treating coughing associated with Idiopathic Pulmonary Fibrosis (IPF), a debilitating disease characterized by the scarring or thickening of tissues deep in the lung. A 24 patient trial showed that Thalomid decreased cough by 65% and improved cough specific ...

Astellas submits NDA for Advagraf for prophylaxis of Organ Rejection

Astellas Pharma US has submitted a New Drug Application (NDA) to the FDA seeking approval for Advagraf (tacrolimus extended release capsules) for the prophylaxis of Organ Rejection in adult kidney transplant recipients and adult male liver transplant recipients. The NDA submission is based on six randomized and comparative studies of 2,842 (1,689 tacrolimus extended release) kidney transplant recipients and 689 ...

BayerHealthCare filed new contraceptive patch in European Union

Bayer HealthCare has submitted an application for marketing authorization in the European Union for a new transparent low dose contraceptive patch (ethinylestradiol/ gestodene). France will serve as the reference member state in the decentralized procedure for gaining marketing authorization in countries in the European Union...

CHMP recommends Avastin with chemotherapy and gemcitabine for Ovarian Cancer

Roche announced that the Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for the use of Avastin (bevacizumab) in combination with chemotherapy (carboplatin and gemcitabine) as a treatment for women with recurrent, platinum-sensitive ovarian cancer. Ovarian cancer has the highest mortality rate of all gynaecological cancers. Almost 230,000 women worldwide are diagnosed with this cancer ...

CHMP recommends use of Tradjenta (Boehringer/Eli Lilly) with Insulin in Type 2 Diabetes patients

Boehringer Ingelheim and Eli Lilly and Company have announced that they have received a Positive Opinion from the European Medicines Agency’s (EMA) medicinal committee recommending expanding the therapeutic indication for the DPP-4 inhibitor Trajenta (linagliptin). If approved by the European Commission, this will expand the indicated use of Trajenta by the combination with insulin in adults with Type 2 ...

Eon Mini neurostimulator (St Jude Medical ) receives CE Mark for Migraine

St. Jude Medical has gained approval for its Eon neurostimulators, including its Eon Mini, which the company claims as the world's smallest rechargeable device in the space. the device is as big as a man's watch and weighs about 1 ounce, powered by a battery that can recharge for about 10 years. The peripheral nerve stimulation device delivers mild electrical ...

FDA approves Eylea (Regeneron) for Macular Oedema following Central Retinal Vein Occlusion

The FDA has approved Eylea (aflibercept) Injection, from Regeneron, for the treatment of Macular Oedema following Central Retinal Vein Occlusion (CRVO). The recommended dose for Eylea is 2 milligrams (mg) every 4 weeks (monthly). The approval of Eylea for Macular Oedema following CRVO was based on data from the Phase III COPERNICUS and GALILEO studies.

In both studies, the ...

Phase III study results for serelaxin (Novartis) for Acute Heart Failure

Phase III study results show that investigational RLX030 (serelaxin) reduced all-cause mortality in patients with Acute Heart Failure (AHF). The six-month RELAX-AHF study shows that RLX030 reduces the number of deaths in patients with this disease, which has a higher mortality rate than most other cardiovascular diseases. The study had two primary endpoints using different scales to measure reduction in ...

CHMP recommends approval of Cialis (Eli Lilly) for Benign Prostatic Hyperplasia

The CHMP in the EU has recommended approval of Cialis (tadalafil), from Eli Lilly and Co, for once daily use for the treatment of the signs and symptoms of Benign Prostatic Hyperplasia (BPH). The opinion is now referred for final action to the European Commission, which has the authority to approve medicines for the EU. The Commission usually decides on ...

CHMP recommends Constella (Almirall) for for the symptomatic treatment of Irritable Bowel Syndrome.

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended the authorisation of the first medicine specifically for the symptomatic treatment of Irritable Bowel Syndrome (IBS) in the European Union (EU). The Agency is recommending that Constella (linaclotide) from Almirall in Europe, be authorised for adults with moderate to severe IBS with constipation (IBS-C), a common ...

CHMP recommends Eliquis (BMS/Pfizer) for Prevention of Stroke and Systemic Embolism in NVAF patients

BMS and Pfizer have announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending that Eliquis (apixaban) be granted approval for the Prevention of Stroke and Systemic Embolism in adult patients with nonvalvular atrial fibrillation (NVAF) and one or more risk factors for stroke The positive ...

CHMP recommends Eylea (Bayer HealthCare) for wet AMD

On 20 September 2012, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Eylea (aflibercept), 40 mg/ml, solution for injection intended for the treatment of Neovascular (wet) Age-related Macular Degeneration (AMD). The applicant for this medicinal product is Bayer Pharma AG. The active substance of ...

CHMP recommends Galvus plus insulin and Eucras triple therapy for Type 2 Diabetes

Novartis announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued two positive opinions for new indications for the use of Galvus (vildagliptin) and Eucras (vildagliptin and metformin) in combination with other treatments for Type 2 Diabetes patients. The first positive opinion was for Galvus in combination with insulin, with or without metformin, for ...

CHMP recommends NexoBrid for treatment of Burns

The European Medicines Agency has recommended approval of NexoBrid (concentrate of proteolytic enzymes enriched in bromelain) from Teva, an orphan-designated medicine, for removal of eschar in adult patients with deep partial- and/or full-thickness thermal burn. Eschar is the dried-out, thick, leathery, black necrotic tissue that covers severe burn wounds. Its removal is essential to initiate the wound healing process and ...

CHMP recommends Picato (Leo Pharma) for treatment of Actinic Keratosis

On 20 September 2012, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Picato, 150 micrograms/g, 500 micrograms/g gel intended for the cutaneous treatment of non-hyperkeratotic, non-hypertrophic Actinic Keratosis in adults. The applicant for this medicinal product is LEO Pharma A/S....

CHMP recommends Votubia (Novartis) for Renal Angiomyolipoma

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion for Votubia (everolimus) tablets for the treatment of adult patients with renal angiomyolipoma associated with tuberous sclerosis complex (TSC) who are at risk of complications (based on factors such as tumor size or presence of aneurysm, or presence of multiple or ...

Lundbeck files vortioxetine at EMA for Major Depressive Episodes

Lundbeck A/S has announced the submission to the European Medicines Agency (EMA) of a marketing authorisation application (MAA) for the approval of the investigational multimodal antidepressant vortioxetine (Lu AA21004), and the dossier has been accepted for review. Vortioxetine belongs to a new generation of antidepressants that has been developed for the treatment of patients with major depressive episodes (MDE).The data ...

Lundbeck files vortioxetine at EMA for Major Depressive Episodes

Lundbeck A/S has announced the submission to the European Medicines Agency (EMA) of a marketing authorisation application (MAA) for the approval of the investigational multimodal antidepressant vortioxetine (Lu AA21004), and the dossier has been accepted for review. Vortioxetine belongs to a new generation of antidepressants that has been developed for the treatment of patients with major depressive episodes (MDE).The data ...

Assessment finds some benefit of Eliquis (BMS/Pfizer) in patients with hip replacements

The German Institute for Quality and Efficiency in Health Care (IQWiG) has carried out an early benefit assessment of Eliquis (apixaban), from BMS/Pfizer, to detect any added benefits after operations to replace a hip or knee joint. Its studies showed that apixaban was more effective in preventing symptomatic Deep Vein Thrombosis than the comparator therapy: about one in 1000 patients ...

FDA approves Prolia(Amgen) for treatment of Male Osteoporosis

Amgen announced the FDA has approved a new indication for Prolia (denosumab) as a treatment to increase bone mass in men with Osteoporosis at high risk for fracture. Prolia, the first FDA approved RANK Ligand inhibitor, is a subcutaneous injection administered by a health care professional every six months. According to the National Osteoporosis Foundation,two million men in the U.S. ...

FDA approves somo-v Automated Breast Ultra Sound System for dense breast imaging

The FDA on 18 September 2012 approved the somo-v Automated Breast Ultrasound System (ABUS) from U-Systems Inc., which is the first ultrasound device for use in combination with a standard mammography in women with dense breast tissue who have a negative mammogram and no symptoms of breast cancer.

Dense breasts have a high amount of connective and glandular tissue ...

Positive results from study of pTeroPure (Glanbia) in patients with high cholesterol

New findings from a Phase II/III trial of pTeroPure (pterostilbene), from Glanbia, show this nutritional ingredient significantly reduced blood pressure in adults. The double-blind, placebo-controlled trial included 80 adults averaging 54 years of age with high cholesterol (total cholesterol of 200 or greater and/or LDL cholesterol of 100 or greater). Most participants were women (71%) and some had been diagnosed ...

Boehringer files Tomtovok at EMA for NSCLC

Boehringer Ingelheim has announced the submission of a Marketing Authorisation Application to the European Medicines Agency for approval of Tomtovok (afatinib) the first irreversible ErbB Family Blocker, as a treatment for patients with EGFR (ErbB1) mutation positive Non-Small Cell Lung Cancer. Afatinib has demonstrated unprecedented efficacy versus chemotherapy in the Phase III LUX-Lung 3 registration trial, which provides pivotal support ...

Janssen Biotech submit application to FDA for Simponi as treatment for adults with active Rheumatoid Arthritis

Janssen Biotech has submitted a Biologics License Application (BLA) to the FDA requesting expanded approval for an intravenously delivered form of Simponi (golimumab) for the treatment of adults with moderately to severely active Rheumatoid Arthritis. This is supported by findings from the Phase III trial of Simponi, the GO-FURTHER study, which evaluated the safety and efficacy of intravenously administered Simponi, ...

Positive results from study of STX 209 (Seaside Therapeutics) for patients with Fragile X Syndrome

A new study shows STX 209 (arbaclofen), from Seaside Therapeutics, is effective for addressing the social withdrawal and challenging behaviors characteristic of Fragile X Syndrome, making it the first such discovery and potentially the first for autism spectrum disorder. The Phase II clinical trial initially recruited 63 subjects at 12 sites across the US and participants ranged in age from ...

Results of DEFINE and CONFIRM trials of BG 12(Biogen IDEC) in Multiple Sclerosis published in NEJM

Biogen Idec announced that detailed results from its two pivotal clinical trials evaluating oral BG-12 (dimethyl fumarate) for the treatment of Multiple Sclerosis (MS) were published in the Sept. 20, 2012 issue of The New England Journal of Medicine (NEJM). Data from the Phase III DEFINE and CONFIRM studies show that dimethyl fumarate (240 mg), administered twice daily (BID) or ...

Baxter acquires EU licence to rigosertib from Oncanova

Baxter International Inc. and Onconova Therapeutics Inc.have announced that they have entered into a European licensing agreement for rigosertib, a novel targeted anti-cancer compound from Onconova currently in a Phase III study for the treatment of a group of rare hematologic malignancies called Myelodysplastic Syndromes and in a Phase II/III study for Pancreatic Cancer. Under the terms of the agreement, ...

Merck Serono withdraws EMA application for treatment of Non Small Cell Lung Cancer

Merck-Serono announced the strategic decision to voluntarily withdraw the marketing authorization application to the European Medicines Agency of a label extension for Erbitux (cetuximab) in combination with standard first-line platinum-based chemotherapy in patients with advanced or metastatic Non-Small Cell Lung Cancer with high epidermal growth factor receptor expression. The decision to withdraw the application was based on feedback from European ...

Positive results of Phase III study of Zytiga (Janssen Biotech) in metastatic Prostate Cancer

Results of a Phase III trial of Zytiga (abiraterone acetate), from Janssen Biotech, confirm it offers a significant survival benefit to patients with castration-resistant metastatic Prostate Cancer. The study, the first Phase III trial to show a significant survival benefit for this kind of drug, involved 1195 patients in thirteen countries, and compared the effects of prescribing Zytiga and the ...

TC 5619 (Targacept) fails Phase II trial in ADHDi

Targacept Inc., has announced top-line results from a Phase II trial of TC-5619 as a treatment for inattentive-predominant attention deficit/hyperactivity disorder (ADHDi). In the trial, TC-5619 did not meet the primary outcome measure, change from baseline on the inattention subscale of the Conners' Adult ADHD Rating Scale-Investigator-Rated (CAARS-INV), after four weeks of treatment versus placebo. Across the study measures, patients ...

RepliGen withdraws application at EMA for SecreFlo an agent for Pancreatic Imaging

EMA has been advised by RepliGen of its decision to withdraw its application for SecreFlo (synthetic secretin human) as an agent for magnetic resonance imaging to improve the detection of pancreatic duct abnormalities in patients with pancreatitis....

FDA Advisory committee rejects lixivaptan

The Cardiovascular and Renal Drugs Advisory Committee of the FDA has recommended againstthe approval of lixivaptan from CardioKine/Cornerstone for the treatment of symptomatic hypervolemic and euvolemic Hyponatraemia associated with Heart Failure. The panel also voted 5-3 against the drug's use in Syndrome of Inappropriate Antidiuretic Hormone (SIADH).The risks of the drug outweighed its modest benefit in raising sodium levels and ...

FDA approves Lospa Knee System (Corentec America) for Knee Replacement Surgery

The FDA has given clearance to market the Lospa Knee System, from Corentec America in the United States. The innovative Knee Joint Replacement System is available and offers an anatomically featured shape for both a cruciate retaining (CR) and a posterior stabilized (PS) knee within a single system. This ensures successful patient outcomes with natural knee range of motion and ...

Orexo files Zubsolv at FDA for treatment of Opioid Dependence

Orexo files at FDA for Zubsolv (buprenorphine and naloxone) for the treatment of Opioid Dependence. The earlier submission is expected to be of major commercial importance, as it provides a potential launch of Zubsolv in the third quarter of 2013 – ahead of other branded competitors. In clinical studies Zubsolv has demonstrated an accelerated dissolve time, has a smaller tablet ...

Positive results from pivotal study of BEMA Buprenorphine/Naloxone (Biodelivery Sciences) for Opioid Dependence

A pivotal pharmacokinetic study BNX-103 for BEMA Buprenorphine/Naloxone from Biodelivery Sciences Inc, has provided positive results in treatment of Opioid Dependence. The drug utilizes the patented BioErodible MucoAdhesive (BEMA) technology to deliver buprenorphine combined with the opioid antagonist naloxone. The goals of the study were to demonstrate that two key pharmacokinetic parameters, maximum drug plasma concentration (Cmax) and total drug ...

Dalbavancin (Durata Therapeutics) QT study results

Results from a QT study of dalbavancin from Durata Therapeutics were presented at the 52nd Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) and showed that in this study dalbavancin had no clinically significant impact on cardiac conduction. The drug is currently under investigation in two ongoing, global, Phase III clinical trials for the treatment of acute bacterial skin and ...

FDA reviews sNDA of Vyvanse (Shire) as maintenenace treatment for young patients with ADHD

The FDA has accepted the filing for review of a supplemental New Drug Application (sNDA) for Vyvanse (lisdexamfetamine dimesylate) Capsules, from Shire, as a maintenance treatment in children and adolescents ages 6 to 17 years with Attention-Deficit/Hyperactivity Disorder (ADHD). This application is based on results of a Phase IIIb, randomized withdrawal, multicenter, extension study to evaluate the long-term maintenance of ...

Legion HK Hinge Knee implant launched by Smith & Nephew in US and Canada

Smith & Nephew the global medical technology business, announced the launch of its Legion HK Hinge Knee implant to surgeons in the US and Canada. As the first hinged knee to be designed using normal knee kinematics, the implant provides a new option for those patients facing difficult primary or revision knee surgery....

Lundbeck/Otsuka re-file Abilify Depot with the FDA as a treatment for Schizophrenia

Lundbeck and Otsuka Pharmaceutical Co., Ltd. announced that the FDA has accepted for review the resubmission of the New Drug Application (NDA) for aripiprazole depot formulation, a potential treatment for schizophrenia. FDA stated that this resubmission constituted a complete class 2 response to their action letter of July 26, 2012. The Prescription Drug User Fee Act (PDUFA) goal date is ...

No evidence for effect of omega-3 fatty acids on Cardiovascular Risk

In a study that included nearly 70,000 patients, supplementation with omega-3 polyunsaturated fatty acids was not associated with a lower risk of all-cause death, cardiac death, sudden death, heart attack, or stroke. Evangelos C. Rizos of the University Hospital of Ioannina, Ioannina, Greece, and colleagues performed a large-scale synthesis of the available randomized evidence by conducting a systematic review and ...

Phase II success for resminostat (4SC) in Liver Cancer

4SC AG announced the publication of convincing overall survival data from a Phase II study with its lead anti-cancer drug resminostat applied as a novel combination therapy approach with sorafenib in second-line advanced Liver Cancer at the 2012 annual meeting of the International Liver Cancer Association in Berlin, Germany, on 16 September 2012.

The international, open-label, two-arm SHELTER ...

18F Flutemetamol (GE HealthCare) Beta Amyloid studies positive

GE Healthcare announced pooled results from Phase III brain autopsy and biopsy studies on the investigational PET amyloid imaging agent, [18F]flutemetamol, which showed a strong concordance between [18F]flutemetamol images and Alzheimer's disease-associated beta amyloid brain pathology.For patients from four separate biopsy studies [18F]flutemetamol detected beta amyloid with a median sensitivity ranging from 75-100 percent and specificity ranging from 99-100 percent. ...

EPI 743 (Edison Pharmaceuticals) granted orphan status for Leigh Syndrome in EU

Edison Pharmaceuticals announced today that the Committee for Orphan Medicinal Products at the European Medicines Agency, has granted orphan designation to EPI 743 for the treatment of Leigh syndrome. Leigh Syndrome is a very rare and severe disease caused by mutations in mitochondrial respiratory enzymes, leading mainly to neurological deficits and a poor survival for these patients. In June 2012 ...

Evidence of benefit of Promitor (Tate & Lyle) for Nutritional Health

Two new research studies provide evidence that certain higher-fibre diets can in fact be well-tolerated, and that fibre may play an important role in supporting a healthy gut as well as promoting calcium absorption. In a crossover study, 23 adolescents 12-15 years old were given controlled diets over two, three-week sessions separated by a one-week washout period. The diets were ...

FDA approval for Aubagio(Sanofi/Genzyme) as a treatment for relapsing Multiple Sclerosis

Sanofi and its subsidiary Genzyme announced that the FDA has approved Aubagio (teriflunomide) as a new once-daily, oral treatment indicated for patients with relapsing forms of Multiple Sclerosis (MS). Aubagio has shown significant efficacy across key measures of MS disease activity,including reducing relapses, slowing the progression of physical disability, and reducing the number of brain lesions as detected by ...

Impella CP heart pump (Abiomed Inc,) receives 510(k) clearance in USA

Abiomed, Inc., announced it has received 510(k) clearance from the FDA for a new percutaneous, catheter-based Impella device providing peak flows of approximately four liters of blood per minute. The increased flow is delivered on the same console platform, 9 French catheter, and introducer as the Impella 2.5. This new heart pump will be marketed as the Impella CP (Cardiac ...

Positive results from DOLAB study for docosahexaenoic acid shows improvement in reading and behaviour in underperforming children

Results of the DHA Oxford Learning and Behaviour (DOLAB) study suggests that taking lifes DHA (docosahexaenoic acid), an omega-3 fatty acid, from Martek Biosciences, could be a simple and effective way to improve reading and behaviour in healthy but underperforming children. The researchers identified 362 healthy 7 to 9 year-olds attending primary schools and who had underperformed in standardized reading ...

CPL 1001 (Sorbent Therapeutics) success in Phase II Heart Failure trial

There has been positive data from a randomized, double-blind Phase IIa clinical study of CLP 1001 from Sorbent Therapeutics. In the study of 111 Heart Failure patients with chronic kidney disease, CLP 1001 demonstrated improvement in Heart Failure symptoms as compared to placebo. CLP1001-treated patients achieved significantly greater weight loss – an accepted measurement of fluid retention – as compared ...

New data for suvorexant (Merck Inc.) for treatment of Insomnia

Merck Inc., announced new data for suvorexant, the investigational medicine for the treatment of Insomnia. The new data are from one of the longest, continuously-dosed, placebo-controlled trials of a sleep medication ever conducted. This 12-month study was designed to assess the safety of suvorexant, while also evaluating its longer term efficacy. Merck presented new results from a two-month discontinuation ...

Phase II success for bavituximab (Peregrine Pharma) in NSCLC

Interim results were presented from a 121 patient randomized, double-blind, placebo-controlled Phase IIb trial of bavituximab from Peregrine Pharma, in patients with refractory Non-Small Cell Lung Cancer (NSCLC). The blinded study evaluated two dose levels of bavituximab (bavituximab-containing arms) given with docetaxel versus docetaxel plus placebo (control arm). The interim data showed a statistically significant improvement in overall survival (Hazard ...

New Phase III trial tests LMTX (TauRX Therapeutics) in patients with Pick's Disease

A new global Phase III clinical trial will test LMTX, from TauRx Therapeutics, in patients with a type of Frontotemporal Dementia (FTD) also known as Pick's Disease. The study focuses on a type of FTD known as behavioural-variant, or bvFTD, which can cause early changes in personality and loss of empathy. A large percentage of these patients have a specific ...

IQWiG finds Incivek/Incivo (J&J Janssen Cilag) offers some advantages for Hepatitis C patients

The German Institute for Quality and Efficiency in Health Care (IQWiG) has examined whether Incivek/Incivo (telaprevir), from J&J Janssen Cilag, offers an added benefit for patients with Hepatitis C compared to conventional therapy. The assessment finds that the drug offers advantages in various groups of patients with chronic Hepatitis C infection of genotype 1. The available studies provide proof, indications ...

Apremilast (Celgene) success in PALACE 2 & 3 trials for Psoriatic Arthritis

Celgene International Sàrl, a subsidiary of Celgene Corporation announced that statistical significance for the primary endpoint of ACR20 at week 16 was achieved for patients receiving apremilast 20 mg and 30 mg BID in both the PALACE-2 & 3 phase III studies. Positive PALACE-1 data was previously reported.

PALACE-2 & 3 are the second and third of three pivotal ...

Janssen responds to FDA Complete Response Letter for Xarelto for Acute Coronary Syndrome

Janssen Research & Development, LLC has submitted its reply to the Complete Response Letter from the FDA for the use of Xarelto (rivaroxaban) 2.5 mg twice daily in combination with standard antiplatelet therapy to reduce the risk of secondary cardiovascular events in patients with Acute Coronary Syndrome (ACS). The submission includes the information requested by the FDA in its letter ...

Phase II success for GSK 961081(GSK/Theravance) for COPD

GSK and Theravance announced positive data from a Phase II study of the dual acting muscarinic antagonist and beta 2 agonist (MABA) GSK 961081 as a treatment for moderate to severe COPD. The trial of 436 subjects showed clinically significant improvements to placebo for FEV1 trough on day 29, the primary endpoint....

EU approve Monarch eTNS system (NeuroSigma) for treatment of Epilepsy

The EU have given CE Certification to the Monarch external Trigeminal Nerve Stimulation (eTNS) system, from NeuroSigma, for the adjunctive treatment of Epilepsy and major depressive disorder, for adults and children 9 years and older. Monarch is composed of an external pulse generator and disposable electric patches placed on the forehead that are replaced daily. The patches can be worn ...

F-18 PET helps predict disease-free survival for Breast Cancer patients

A new study shows that disease-free survival for invasive ductal Breast Cancer (IDC) patients may be easier to predict with the help of F-18-fludeoxyglucose positron emission tomography (PET)/computed tomography (CT) scans. Data show that high maximum standard uptake value (SUVmax) of F-18-FDG in the lymph nodes prior to treatment could be an independent indicator of disease recurrence. Researchers followed 65 ...

FDA votes to support inhaled powder form of tobramycin (Novartis) for patients with Cystic Fibrosis

An FDA drug advisory committee has voted 13 to 1 that there was adequate evidence of efficacy and safety to support the use of tobramycin inhalation powder (TIP), from Novartis, for the management of Cystic Fibrosis (CF) patients whose lungs contain bacteria called Pseudomonas aeruginosa (Pa). It based its recommendation on three Phase III clinical studies involving more than 650 ...

Phase III data on Kalydeco (Vertex) shows benefits for Cystic Fibrosis patients

A Phase III study of Kalydeco (ivacaftor), from Vertex, for patients with Cystic Fibrosis shows the drug significantly improves lung function and reduces pulmonary exacerbations. The STRIVE study randomised 161 patients aged 12 and over with at least one copy of the G551D mutation in the CFTR gene to ivacaftor (150mg every 12 hours) or placebo. Results showed a mean ...

Positive results for Edarbyclor (Takeda) in Phase III study of Hypertension

Results of a 10-week, Phase III study of Edarbyclor (azilsartan medoxomil and chlorthalidone), from Takeda, for patients with Hypertension found the clinic systolic blood pressure (SBP) reductions for Edarbyclor were significantly greater at six and ten weeks than those of azilsartan medoxomil co-administered with hydrochlorothiazide. Data also showed that more patients achieved their target blood pressure levels when taking the ...

European approval for Revestive(Takeda) for Short Bowel Syndrome

Takeda Pharmaceutical Company Limited and NPS Pharmaceuticals, Inc. jointly announced that the European Commission (EC) has granted European market authorization for the medicinal product Revestive (teduglutide), known as Gattex in the US, as a once-daily treatment for adult patients with Short Bowel Syndrome. The marketing authorization follows a positive opinion issued on June 21, 2012, by the Committee for Medicinal ...

FDA approves Elecsys HSV Assays (Roche) for detecting Herpes Simplex virus

The FDA has cleared the Elecsys HSV-1 IgG and HSV-2 IgG assays, from Roche, for detecting Herpes Simplex virus (HSV) types 1 and 2. The assays are for use on Roche's cobas modular platforms. The tests are intended for use with sexually active individuals and expectant mothers as an aid in the presumptive diagnosis of HSV-1 and HSV-2 infection. The ...

Success for SNG 001 (Synairgen) in early Asthma trial

In a mid-stage study of 134 adults who caught a cold, SNG001 from Synairgen, was effective in the most difficult-to-treat patients, preventing asthma symptoms from getting worse during the first week of infection and treatment. There was also a 65 percent reduction in the number of patients who experienced asthma attacks during the treatment period compared with a group on ...

Baxter files BAX 326 at FDA for management of Haemophilia B

Baxter has announced that the company has submitted a biologics license application (BLA) to the FDA for approval of BAX 326, a recombinant factor IX (rFIX) protein being investigated for the treatment and prophylaxis of bleeding episodes for patients over 12 years of age with Haemophilia B. Haemophilia B, also known as Christmas disease, is the second most common type ...

EC approves Inlyta (Pfizer) for Real Cell Carcinoma

The European Commission (EC) has granted marketing authorization for Inlyta (axitinib) from Pfizer for the treatment of adult patients with advanced Renal Cell Carcinoma a type of kidney cancer, after failure of prior treatment with sunitinib or a cytokine. The Inlyta data demonstrates a statistically significant improvement in progression free survival compared with sorafenib, and supports the continued role for ...

FDA approves Bosulif (Pfier) for treatment of PH+CML

Pfizer Inc. has announced that the FDA has approved Bosulif (bosutinib),an Abl and Src kinase inhibitor, for the treatment of adult patients with chronic, accelerated, or blast phase Philadelphia chromosome-positive (Ph+) Chronic Myelogenous Leukemia (CML) with resistance, or intolerance to prior therapy. Patients in the registrational trial included patients who were previously treated with imatinib [Gleevec] or imatinib plus at ...

FDA approves new dosage of Exelon (Novartis) for patients with Alzheimers

The FDA has approved a higher dose of Exelon (rivastigmine transdermal system), from Novartis, for the treatment of people with mild to moderate Alzheimer's disease. The new dosage strength provides physicians with a new treatment option for patients who are experiencing a decline in overall function and cognition. Approval of the patch was based on the 48-week OPTIMA study, a ...

Positive data on Esbriet (InterMune) in patients with Pulmonary Fibrosis

New analyses of data from the RECAP extension study of Esbriet (pirfenidone), from InterMune, show that patients with mild-to-moderate Pulmonary Fibrosis (PF) newly-treated with Esbriet in RECAP for 60 weeks had similar FVC and survival outcomes when compared to those treated with Esbriet for the same duration as in previous studies (the CAPACITY trial).

The new analyses showed that the ...

Positive data on QVA 149 (Novartis) from three Phase III studies of COPD

Three new studies of QVA 149 (indacaterol plus glycopyrronium bromide), from Novartis, in the IGNITE Phase III trial program demonstrate the drug significantly improves lung function compared to other COPD therapies. SHINE met its primary endpoint by demonstrating that once-daily QVA 149 improved lung function as measured by trough FEV1 compared to once-daily indacaterol maleate and once-daily glycopyrronium. It was ...

Positive results from studies of Seebri Breezhaler (Novartis) for patients with COPD

Results of the first pooled analysis of GLOW1 and GLOW2 data demonstrated that patients with COPD using the Seebri Breezhaler (glycopyrronium bromide), from Novartis, experienced rapid, sustained and clinically meaningful bronchodilation over 52 weeks. The improvement in FEV1 was seen within five minutes after the first dose on Day 1 and was sustained throughout the 52-week period (p<0.001 vs. placebo). ...

Results show benefits of RX Herculink Elite Stent (Abbott Vascular) in patients with Renal Artery Stenosis

Results from the HERCULES trial evaluating the safety and effectiveness of the RX Herculink Elite Stent, from Abbott Vascular, found that Renal Artery Stenosis patients with higher blood pressure levels at baseline had the most dramatic reduction in blood pressure following intervention. At the start of the trial the mean systolic blood pressure of the trial group was 162 mm ...

Studies show Onbrez Breezhaler/Arcapta Neohaler (Novartis) effective for patients with COPD

New results from a pooled post-hoc sub-group analysis from three studies (INVOLVE, INHANCE and INLIGHT2) showed that Onbrez Breezhaler/Arcapta Neohaler (indacaterol maleate), from Novartis, was statistically significantly more effective than OL tiotropium at improving breathlessness in COPD. These three randomized studies included 3,176 patients with moderate-to-severe COPD and assessed patients randomized to receive once-daily indacaterol maleate 150 mcg, once-daily indacaterol ...

Positive data from Phase III trial of Spiriva (Boehringer) in Asthma patients

Initial data from the Phase III UniTinA-asthma program reveals that Spiriva (tiotropium bromide), from Boehringer, delivered daily via the Respimat inhaler significantly improved lung function and reduced Asthma exacerbations in patients who remained symptomatic on current treatment with at least high dose inhaled corticosteroids (ICS) and long-acting beta agonists (LABA). The two studies were replicate double-blind parallel-group trials including Asthma ...

FDA approves Afinitor Disperz(Novartis) for SEGA Tumours

The FDA has on 29 August 2012 approved Afinitor Disperz (everolimus tablets for oral suspension; Novartis), a new pediatric dosage form of Afinitor (everolimus) indicated for treatment of Tuberous Sclerosis Complex (TSC) in patients aged >1 year who are diagnosed with Subependymal Giant Cell Astrocytoma (SEGA) that cannot be treated with surgery. Afinitor Disperz is the first approved pediatric-specific dosage ...

Aquilion CT scanner (Toshiba) accurately assess coronary blockages

The Toshiba Aquilion 320-detector computed tomography (CT) scanner can accurately sort out which people with chest pain need or don't need an invasive procedure such as cardiac angioplasty or bypass surgery to restore blood flow to the heart, according to an international study. The CORE 320 study is the first prospective, multicenter study to examine the diagnostic accuracy of high ...

Ariad Pharma files ponatinib at EMA for CML and Ph+ALL

Ariad Pharmaceuticals has submitted its marketing authorisation application to the European Medicines Agency for ponatinib for resistant or intolerant Chronic Myeloid Leukaemia and Philadelphia-chromosome positive Acute Lymphoblastic Leukaemia.The drug was filed in the US for these indications in July 2012....

Aspirin-clopidogrel no better than aspirin alone for patients with Lacunar Stroke

Aspirin combined with the antiplatelet drug clopidogrel is no better than aspirin alone for stroke prevention in people with a history of lacunar strokes, and the combination carries a greater risk of gastrointestinal bleeding, according to results of a trial funded by the National Institutes of Health. Lacunar strokes occur due to chronic high blood pressure and typically produce small ...

Bayer HealthCare submit NDA for BAY 73-4506 as treatment for GIST

Bayer HealthCare has submitted a New Drug Application (NDA) to the FDA for BAY 73-4506 (regorafenib) for the treatment of metastatic and/or unresectable Gastrointestinal Stromal Tumors (GIST) in patients whose disease has progressed despite prior treatment.

The submission is based on data from the pivotal Phase III GRID trial, which showed that regorafenib plus best supportive care (BSC) significantly improved progression-free ...

FDA approves Linzess (Forest/Ironwood) for Chronic Constipation and IBS

The FDA on 30 August 2012 approved Linzess (linaclotide) from Forest Labs and Ironwood Pharma, to treat Chronic Idiopathic Constipation and to treat Irritable Bowel Syndrome with Constipation (IBS-C) in adults. Almirall has the European rights and has filed a marketing application to EMA for Irritable Bowel Syndrome with Constipation....

FDA approves Xtandi(Astellas/Medivation)to treat castration- resistant Prostate Cancer

The FDA has on 31 August 2012 approved Xtandi (enzalutamide) from Astellas/Medivation to treat men with late-stage (metastatic) castration-resistant Prostate Cancer that has spread or recurred, even with medical or surgical therapy to minimize testosterone. Approved for prostate cancer patients previously treated with docetaxel, another anti-cancer treatment, Xtandi was reviewed under the FDA’s priority review program. The program provides for ...

Janssen submit MAA to the EMA for TMC 207 as treatment for multi-drug resistant Tuberculosis

Janssen Pharmaceuticals has submitted a Marketing Authorisation Application to the EMA seeking conditional approval for the use of the investigational drug TMC 207 (bedaquiline) as an oral treatment as part of combination therapy for pulmonary, multi-drug resistant Tuberculosis (MDR-TB) in adults. The submission is supported by 24-week data from the Phase II clinical development program, which includes an open-label study ...

Noven Pharma files low-dose mesylate salt of paroxetine for Menopause

Noven Pharmaceuticals, Inc., a wholly-owned subsidiary of Hisamitsu Pharmaceutical Co., Inc., has submitted to the FDA a New Drug Application (NDA) seeking approval to market low-dose mesylate salt of paroxetine (LDMP) for the treatment of vasomotor symptoms associated with menopause. In March 2012, Noven announced completion of the LDMP clinical development program, which included two Phase III studies involving an ...

Study finds link between chocolate consumption and Stroke risk

In a study based on a prospective investigation of a large group of male patients over 10 years, researchers have seen a link between chocolate consumption and stroke risk. The team looked at questionnaire responses from 37,103 Swedish men aged 49 to 75 and using data from the Swedish Hospital Discharge Registry, researchers identified 1,995 cases of first stroke among ...

FDA Advisory Panel recommends Humira (Abbott Labs) for treatment of Ulcerative Colitis

The FDA Gastrointestinal Drugs Advisory Panel voted 15-2 to recommend Humira (adalimumab) from Abbott Labs for reducing the signs and symptoms of moderate to severe Ulcerative Colitis in patients who have an inadequate response to conventional therapy.The members of the Panel considered that the benefits outweight the potential risks with the drug. The Panel called for post-approval studies in Ulcerative ...

EMA 401 has Phase II success for Post Herpetic Neuralgia

There have been positive headline results from the Phase II clinical trial of EMA 401 from Spinifex Pharmaceuticals, in Postherpetic Neuralgia (PHN), a painful condition that develops in some patients following herpes zoster (shingles) and where existing therapy does not relieve pain in all individuals. The clinical trial met its primary endpoint, reduction in mean daily pain score versus placebo ...

Pomaglumetad methionil (Eli Lilly) fails Phase II studies in Schizophrenia

Eli Lilly has announced the decision to stop ongoing clinical studies investigating pomaglumetad methionil, also known as mGlu2/3, for the treatment of patients suffering from Schizophrenia. The decision was made after a recently conducted independent futility analysis concluded HBBN, the second of Lilly's two pivotal studies, was unlikely to be positive in its primary efficacy endpoint if enrolled to completion. ...

Positive results from study of PressureWire (St Jude Medical) in PCI patients

Results of the FAME II Trial demonstrate patients with FFR-guided stenting that use PressureWire (technology used to measure blood flow restriction in the coronary arteries), from St Jude Medical, plus the best available medical therapy had superior outcomes to those treated with medical therapy alone. Results revealed this yielded an 86 percent relative risk reduction for unplanned re-admission to the ...

Xarelto(Bayer/Janssen) sub group analysis of TIMI trial shows reduction in mortality for ACS patients

A major subgroup analysis from the ATLAS ACS 2-TIMI 51 study of 7,817 patients with ACS and a recent ST-segment elevation myocardial infarction (STEMI) demonstrated that oral anticoagulant Xarelto (rivaroxaban) 2.5 mg twice daily, from Bayer/Janssen, when added to standard antiplatelet therapy, provides a significant mortality benefit. The analysis showed that adding rivaroxaban to standard antiplatelet therapy significantly reduced the ...

Architect Testosterone assay(Abbott) 2nd Generation receives CE Mark

Abbott has received CE Marking (Conformite Europeenne) for a testosterone assay with improved sensitivity and clinical utility. With a simple blood test, the ARCHITECT 2nd Generation Testosterone Assay can accurately measure the wide range of testosterone levels seen in a number of different patient populations and clinical settings.Testosterone assays play an important role in the diagnosis and management of many ...

EU approves Zinforo (AstraZeneca) for cSSTI and CAP infections

AstraZeneca announced that the European Commission has granted Marketing Authorisation to Zinforo(ceftaroline fosamil), a new intravenous cephalosporin antibiotic, for the treatment of adult patients with complicated Skin and Soft Tissue Infections (cSSTI) or Community Acquired Pneumonia (CAP). This makes Zinforo the only approved cephalosporin monotherapy in Europe with demonstrated clinical efficacy against methicillin-resistant Staphylococcus aureus (MRSA), a common cause ...

EU Commission approves Jakavi (Novartis) for Myelofibrosis

Novartis received approval from the European Commission for Jakavi (INC424, ruxolitinib), a JAK 1 and JAK 2 inhibitor for the treatment of disease-related splenomegaly or symptoms in adult patients with primary myelofibrosis (also known as Chronic Idiopathic Myelofibrosis), post-polycythemia vera myelofibrosis or post-essential thrombocythemia myelofibrosis. The European Commission's decision was based on positive findings from the COMFORT (COntrolled MyeloFibrosis Study ...

FDA approves Stribild ( Gilead Sciences) for treatment of HIV-1 Infection

Gilead Sciences,announced that the FDA has approved Stribild (elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg), a complete once-daily single tablet regimen for HIV-1 infection for treatment-naïve adults. Stribild, referred to as “Quad” prior to FDA approval, combines four compounds in one daily tablet: elvitegravir, an integrase inhibitor; cobicistat, a pharmacoenhancing agent; emtricitabine and tenofovir disoproxil ...

Positive results in trial of Solitaire (Covidien) for blood flow restoration

The Solitaire Flow Restoration Device for opening blocked arteries, from Covidien, performs better than a conventional device, according to new results from the SWIFT trial which have been published in The Lancet.

In the double-blind, randomised trial of 113 patients, the researchers compared the performance of the Solitaire device to the Merci retriever. Patient outcomes were significantly improved in the ...

EU approves Zyclara (Meda AB) for Actinic Keratoses

Meda AB has announced that the European Commission (EC) has granted marketing authorization for Zyclara (imiquimod 3.75% cream) in the European Union. Zyclara is a patented product for the treatment of Actinic Keratosis. The approval is valid in all EU countries....

Genzyme receives Refusal to File Letter from FDA relating to Lemtrada application for Multiple Sclerosis

Genzyme has received a Refuse to File letter from the FDA in response to the supplemental Biologics License Application (sBLA) for the approval of Lemtrada (alemtuzumab) as a treatment for relapsing Multiple Sclerosis. After collaborative consultations with the FDA, the agency requested that the company modify the presentation of the data sets to enable the agency to better navigate the ...

Positive Phase III EMILIA study data for T-DM1 (Genentech/Roche) in Breast Cancer patients confirmed

Genentech has announced updated results from the Phase III EMILIA study, which showed that trastuzumab emtansine (T-DM1) significantly extended the lives (improved overall survival) of people with HER2-positive metastatic Breast Cancer (mBC) compared to the combination of lapatinib and Xeloda (capecitabine). The EMILIA study, in people with HER2-positive mBC who had previously received Herceptin (trastuzumab) and taxane chemotherapy, has now ...

LCZ 696 success in study for Heart Failure with preserved ejection fraction

The Phase II PARAMOUNT study showed that the investigational compound LCZ 696 (Novartis) is the first therapy to significantly reduce a key predictor of morbidity and mortality in patients with a condition called heart failure with preserved ejection fraction (HF-PEF). This difficult-to-treat disease affects up to half of the 20 million people with heart failure in Europe and the US ...

TRILOGY ACS study results for Efient/Effient (Daiichi Sankyo/Eli Lilly)

Daiichi Sankyo Company, Limited and Eli Lilly and Company have announced data from the TRILOGY ACS study, a phase III trial comparing Effient/Efient (prasugrel) plus aspirin to clopidogrel plus aspirin in patients with unstable angina (UA) or non-ST elevation myocardial infarction (NSTEMI), who were managed medically without an artery-opening procedure. At 30 months, 13.9 percent of prasugrel patients versus 16.0 ...

Two new Phase III studies of Xarelto (Bayer HealthCare) initiated for AF patients scheduled for surgery

Bayer HealthCare has initiated two new studies investigating Xarelto (rivaroxaban) in patients with Atrial Fibrillation who are scheduled for cardioversion or first catheter ablation. X-VeRT is the largest randomised study dedicated to evaluating patients with AF scheduled for cardioversion. It will include approximately 1,500 patients across 17 countries worldwide, including the UK. The study will further examine the efficacy and ...

Watchman LAAC device (Boston Scientific) receives expanded CE indication

European regulators have approved an expanded indication for the Boston Scientific Watchman Left Atrial Appendage (LAA) Closure Device. The new indication offers patients with atrial fibrillation (AF), and a contraindication to warfarin and the newer oral anticoagulants, a new treatment option for Stroke Reduction.

Patients in AF have an increased risk of stroke due to the migration of clots ...

Development of BMS 986094 (BMS/Inhibitex) for Hepatitis C halted

BMS/Inhibitex have discontinued development of BMS 986094, for Hepatitis C, following the death of a participant in a Phase II trial. A spokesperson stated that the decision "was made in the interest of patient safety, based on a rapid, thorough and ongoing assessment of patients". The trial was voluntarily suspended on 1 August 2012. The company states that while "the ...

Mixed results from Phase III studies of LY 2062430 (Eli Lilly) in Alzheimer's Disease patients

Results show that the primary endpoints were not met in either of the two Phase III placebo-controlled EXPEDITION trials of LY 2062430 (solanezumab), from Eli Lilly and Co, in patients with mild-to-moderate Alzheimer's Disease. However, a pre-specified secondary analysis of pooled data across both trials shows statistically significant slowing of cognitive decline in the overall study population.

In addition, secondary ...

Phase III programme of GSK 573719 plus vilanterol (Glaxo Smith Kline/Theravance) for COPD completed

The Phase III programme of GSK 573719 plus vilanterol, from Glaxo Smith Kline and Theravance, involving approximately 6,000 patients with Chronic Obstructive Pulmonary Disease (COPD) has been completed. On 2 July 2012, GSK and Theravance announced the completion of four pivotal studies for GSK 573719 plus vilanterol. The pivotal programme for the drug combo also includes a 52-week safety study, ...

FDA approves WiTouch (Hollywog) for Chronic Back Pain

The FDA has issued two 510(k) clearances allowing Hollywog to market its WiTouch and WiTouch Pro wireless remote controlled devices for Chronic Back Pain. The WiTouch devices are the first wireless remote controlled pain relief device incorporating TENS technology to specifically target back pain. The WiTouch is cleared for over-the-counter, and the WiTouch Pro is cleared for prescription use. An ...

Review finds insufficient evidence for effectiveness of Cytotec(Pfizer) for preventing PPH

A review finds that there is insufficient evidence for the effectiveness of Cytotec (misoprostol), from Pfizer, a drug increasingly used in low- and middle-income countries for preventing postpartum haemorrhage (PPH). It is given to women during Labour to prevent uncontrolled bleeding, and it is included on the WHO's Essential Medicines List for this use.

However, researchers led by Professor Allyson Pollock ...

Medtonic receives CE mark for Viva and Brava CRT-D devices for Heart Failure patients

Medtronic Inc has received CE Mark in Europe for its Viva and Brava Cardiac Resynchronization Therapy with Defibrillation (CRT-D) devices for treating patients with Heart Failure. The family of CRT-Ds features a new algorithm, called AdaptivCRT(R), which significantly improves heart failure patients' response rate to CRT-D therapy, as compared to historical CRT trials, by preserving the patients' normal heart rhythms ...

Sirukumab (Janssen/GSK) to enter Phase III for RA

Janssen Biologics (Ireland) and GSK entered into a co-development and co-commercialisation license agreement with respect to sirukumab (CNTO 136),a human anti-interleukin (IL)-6 monoclonal antibody for Rheumatoid Arthritis.

Two studies comprise the Phase III program and are : SIRROUND-T, A multicentre, randomised, double-blind, placebo-controlled, parallel group study of sirukumab administered subcutaneously in subjects with active RA despite anti-tumor necrosis factor ...

EMA accepts filing for Heplisav (Dynavax Technologies), a vaccine for Hepatitis B.

The EMA has accepted the filing of the Marketing Authorization Application for Heplisav vaccine, from Dynavax Technologies, pursuing an indication for immunization against infection caused by all known subtypes of Hepatitis B virus in adults 18 through 70 years of age and in patients with chronic kidney disease. Acceptance of the MAA confirms that the submission is sufficiently complete to ...

FDA approve SurgiClear (Covalon Technologies) for Wound Healing

The FDA has cleared SurgiClear (antimicrobial dressing), from Covalon Technologies, to cover and protect Wound sites and wound closure devices, as well as secure other primary dressings to a patient's skin. SurgiClear is the first clear antimicrobial silicone surgical dressing that combines silver and chlorhexidine to provide broad spectrum antimicrobial activity for 7 days. SurgiClear is the only antimicrobial surgical ...

Campath/MabCampath (Sanofi/Genzyme) withdraws marketing in EU and US for oncology indications.

Sanofi/Genzyme have withdrawn MabCampath (alemtuzumab) from the European market and established a free distribution programme for B-cell CLL users. In the United States the FDA licence will be maintained but a free Campath Distribution Program will offer the drug freely to patients. The intention is to avoid confusion between Campath/MabCampath and the newly developed version of alemtuzumab for which Sanofi/Genzyme ...

FDA approve new dosage of Suboxone (Reckitt Benckiser) for treating Opioid Dependence

The FDA has approved 4 mg and 12 mg doses of Suboxone (buprenorphine and naloxone) sublingual film, from Reckitt Benckiser, for maintenance treatment of Opioid Dependence, also known as prescription opioid painkiller and heroin addiction. Reckitt Benckiser developed these strengths in an effort to help mitigate the risk of unintentional multi-dose pediatric exposure, which is a major public health concern ...

Positive results in two Phase III studies of Fycompa (Eisai) for Epilepsy

Results from the final pivotal Phase III study and long term Phase III extension study of Epilepsy drug Fycompa (perampanel), from Eisai, have been published online in Epilepsia. Findings from Study 305, one of three pivotal global studies, and the extension study for perampanel add further weight to the growing body of clinical evidence supporting the efficacy and safety of ...

Xience Xpedition everolimus stent (Abbott Vascular) receives CE Mark

The Xience Xpedition Everolimus Eluting Coronary Stent System received CE Mark in Europe for the treatment of Coronary Artery Disease. Abbott Vascular is launching the product immediately in CE Mark countries. Xience Xpedition features a new stent delivery system designed to optimize acute performance, particularly in challenging coronary anatomies. Xience Xpedition is supported by the robust clinical evidence of the ...

Benefit assessment finds no clear advantage of Halaven (Eisai) for Breast Cancer patients

In an early benefit assessment, the German Institute for Quality and Efficiency in Health Care (IQWiG) examined whether Halaven (eribulin mesylate), from Eisai, offers an added benefit compared with the present standard therapy in Breast Cancer patients. According to the results of the assessment, the currently available evidence provides "hints" that Halaven may increase survival time in patients for whom ...

Positive results in Phase III study of MDV 3100 (Medivation Inc) in Prostate Cancer patients

Results of a Phase III clinical trial of the drug MDV 3100 (enzalutamide), from Medivation Inc, show the drug extends life by an average five months in the most advanced stages of Prostate Cancer.

The study, AFFIRM, followed 1199 patients whose cancer that had progressed despite both hormonal and chemotherapy treatments, with 2/3 of patients receiving the drug MDV 3100 ...

Actos (Takeda) US patent expires and Ranbaxy launches generic for Type 2 Diabetes.

The patent has expired in the United States for Actos (pioglitazone)for the treatment of Type 2 Diabetes from Takeda. Ranbaxy will launch a generic now with 180 days exclusivity and with other generic companies to follow ,including Mylan. Actos represented 51.8% of Takeda US revenue and 18% of its total revenue....

Bosatria (GSK) study in severe Eosinophilic Asthma

A year-long study involving 621 patients treated with Bosatria (mepolizumab) from Glaxo Smith Kline found that the rate in patients on mepolizumab of clinically significant exacerbations - defined as episodes requiring oral corticosteroids or a hospital visit - was around half that of those on placebo. But while monthly intravenous injections of the drug cut attacks they failed to produce ...

Delay in review of QT 1571(Novartis) for PAH

The FDA postponed a meeting of the Cardiovascular and Renal Drugs Advisory Committee to review QT 1571 which is imatinib (Gleevec/Glivec in its cancer indication) from Novartis for Pulmonary Arterial Hypertension. Novartis has decided to withdraw the NDA to allow time to produce more information for the FDA...

NICE recommends Xgeva for as a treatment for people with bone metastases from most solid cancer tumours including Breast Cancer

The National Institute for Health and Clinical Excellence (NICE) has published final draft guidance recommending Xgeva(denosumab) from Amgen/GSK as a treatment for people with bone metastases from most solid cancer tumours.It provisionally recommends denosumab for the prevention of skeletal-related events in: •people with bone metastases from breast cancer and •people with bone metastases from solid tumours (other than breast or ...

FDA approves supplemental NDA for Tradjenta (Boehringer/Eli Lilly) for patients with Type 2 Diabetes

The FDA has approved a supplemental new drug application (sNDA) for Tradjenta (linagliptin), from Boehringer Ingelheim and Eli Lilly, for use as add-on therapy to insulin in patients with Type 2 Diabetes. The FDA's decision is based on data from a 52-week, Phase III trial demonstrating the efficacy of Tradjenta in combination with insulin (with or without metformin and/or pioglitazone). ...

IDX 184 (Idenix)trial for Hepatitis C halted by FDA for suspected cardiotoxicity

IDX 184 is a drug from Idenix Pharmaceuticals for treatment of Hepatitis C. The development of the drug has been placed on partial hold by the FDA as the drug may be linked to serious cardiac related adverse events. Idenix maintains that no evidence of cardiotoxicity has been found in its trials but will perform cardiac tests on its 67 ...

Ocriplasmin(Novartis/Thrombogenics) studies for Vitreomacular Adhesion published in NEJM

Novartis has announced the New England Journal of Medicine (NEJM) published the results of two Phase III studies, Studies 006 and 007, of the investigational eye treatment Jetrea ( ocriplasmin). The studies including 652 patients found that ocriplasmin, significantly resolved vitreomacular traction and closed macular holes compared to placebo in patients with vitreomacular adhesion.

Vitreomacular adhesion (VMA), including vitreomacular ...

Positive data from Phase III study of Xgeva (Amgen) in Breast Cancer patients

Treatment with Xgeva (denosumab), from Amgen, resulted in a greater reduction in skeletal-related events in patients with Breast Cancer that spread to the bones compared with zoledronic acid, while also maintaining health-related quality of life, according to the results of a Phase III study published in Clinical Cancer Research. The study randomly assigned 2,046 patients to receive subcutaneous denosumab and ...

Tofacitinib (Pfizer) success in Phase II study for Ulcerative Colitis

A Phase II trial of tofacitinib from Pfizer shows it has potential as an effective treatment for Ulcerative Colitis. The trial studied the efficacy of tofacitinib in 194 adults with severely active forms of the disease. Patients were randomised for treatment with tofacitinib at a dose of 0.5 mg, 3 mg, 10 mg, or 15 mg or were given a ...

Phase II trials show improved survival with Caprelsa (AstraZeneca) for medullary Thyroid Cancer

A new study shows that the chemotherapy drug vandetanib Caprelsa (vandetanib) from AstraZeneca, may extend life for some Thyroid Cancer patients. The results of Phase II trials showed that patients taking the drug lived for 11 months without the cancer progressing, compared with six months for those receiving a placebo. The report was published online Aug. 13 in the journal ...

Quartette (Teva) is FDA filed for Contraception

Teva Women’s Health, Inc., a U.S.-based subsidiary of Teva Pharmaceutical Industries Ltd, has announced that the FDA has accepted for filing its New Drug Application (NDA) for Quartette (levonorgestrel/ethinyl estradiol tablets and ethinyl estradiol tablets) for Contraception....

Cocoa flavanols (Mars Symbioscience) may improve cognition according to Italian study

A study conducted by researchers from the University of L'Aquila in Italy and Mars Symbioscience provides evidence that the regular consumption of dietary cocoa flavanols may improve cognitive function in elderly subjects with early memory decline. Previous research has suggested that the benefits of cocoa flavanols could extend to the brain. However, these studies were either only short-term or did ...

FDA approve Trevo Pro Retriever (Stryker) for clot removal

The Trevo Pro Retriever, from Stryker, has been granted 510(k) market clearance by the FDA for clot removal. Approval is based on clinical results from the TREVO 2 clinical trial presented at the 2012 European Stroke Conference in May. This technology demonstrated the highest rate of revascularization in a randomized embolectomy stroke device trial, and achieved significantly better post-procedure revascularization ...

Nexium(AstraZeneca) to be OTC marketed by Pfizer

AstraZeneca has entered into an agreement with Pfizer Inc. for the over-the-counter (OTC) rights for Nexium (esomeprazole magnesium) currently approved to treat the symptoms of Gastroesophageal Reflux Disease (GERD). Under the terms of the agreement, Pfizer will acquire the exclusive global rights to market Nexium for the approved over-the-counter indications in the United States, Europe and the rest of ...

Vacc-4x (Bionor Pharma) in Phase III trial with Revlimid(Celgene)for HIV treatment

Bionor Pharma announced that the clinical trial application for the placebo-controlled study with Vacc-4x in combination with Celgene`s Revlimid has been approved by the German health regulatory authorities. The study will be conducted at four different clinics in Germany, and will include HIV patients who do not recover a normal CD4 T-cell count (measurement of the immune system) despite receiving ...

Torisel (Pfizer) fails in combination trial with Avastin in Renal Cell Carcinoma

Pfizer Inc. announced that the Phase III INTORACT trial (B1771006), evaluating the combination of bevacizumab plus Torisel (temsirolimus) compared with bevacizumab plus interferon-alfa-2a (IFN-?-2a) in the first-line treatment of patients with advanced Renal Cell Carcinoma (RCC) across risk groups, did not meet its primary endpoint of superiority in extending progression free survival (PFS) in the study population. Additional efficacy endpoints ...

Dutch regulatory authority rejects Cortiment (Cosmo/Ferring) for Ulcerative Colitis

Cosmo Pharmaceuticals received a communication from the Dutch Regulatory Agency (MEB) declining the approval of Cortiment(budesonide with MMX technology), indi­ca­ted for the induction of remission in patients with active, mild to moderate Ulce­ra­tive Colitis. The reasons given for the decline were on the grounds of clinical relevance. Cosmo is awaiting the formal letter to get full disclosure of the reasons ...

FDA approves GeNOsyl MV-1000 (GeNo LLC) for neonates

GeNo LLC has received clearance from the FDA to market its inhaled nitric oxide (NO) delivery system GeNOsyl MV-1000. The target patient population is controlled by the drug labeling for FDA-approved NO which is currently neonates. The GeNOsyl MV-1000 is intended to be used in hospital settings including the NICU and intra-hospital transport settings. The GeNOsyl MV-1000 injects a constant ...

FDA approves Lucentis (Genentech) for treatment of Diabetic Macular Edema

The FDA on 10 August 2012 approved Lucentis (ranibizumab injection) from Genentech for the treatment of Diabetic Macular Edema (DME), a sight-threatening eye disease that occurs in people with diabetes. An injection of the drug is administered once a month by a health care professional. Lucentis is intended to be used along with good diabetic blood sugar control. DME is ...

FDA approves Marqibo (Talon Therapeutics) for Ph-ALL

The FDA has approved the orphan drug Marqibo (vincristine sulfate liposomes injection)from Talon Therapeutics, as a treatment for patients with Philadelphia chromosome negative (Ph-) Acute Lymphoblastic Leukemia (ALL). Marqibo is approved for patients whose leukemia has returned (relapsed) two or more times, or whose leukemia has progressed following two or more regimens of anti-leukemia therapy.

Marqibo contains vincristine, a ...

Positive results from Phase III study of Avastin (Genentech/Roche) in Brain Cancer patients

The Phase III AVAglio study of Avastin (bevacizumab), from Genentech/Roche, plus radiation and temozolomide chemotherapy in people with newly diagnosed Glioblastoma met its co-primary endpoint of a significant improvement in progression-free survival (PFS). In the study, Avastin in combination with radiation and temozolomide chemotherapy significantly extended the time people with this aggressive form of primary Brain Cancer lived without their ...

Study shows almost no difference in mortality with TNF drugs for Rheumatoid Arthritis

A follow-up study of Swedish patients with Rheumatoid Arthritis taking TNF inhibitors Humira, Enbrel and Remicade reveals that there is no significant difference in the rates of death among patients. The study followed 1609 patients between 2003 and 2008. The results have been published in Arthritis and Rheumatism. "While we found no statistically significant difference in mortality rates across the ...

Ganitumab (Amgen) Phase III trial stopped in Pancreatic Cancer

Amgen has announced a decision to stop the ganitumab (AMG 479) Phase III GAMMA (Gemcitabine and AMG 479 in Metastatic Adenocarcinoma of the Pancreas) trial following the recommendation of an independent Data Monitoring Committee (DMC) overseeing the trial. Based on the review of a pre-planned interim analysis, the DMC concluded that the addition of ganitumab to gemcitabine is unlikely to ...

NKTR 102 (Nektar) update on cancer trials

Nektar Therapeutics announced the start of a Phase II study of NKTR 102 (etirinotecan pegol) in patients with bevacizumab (Avastin)-resistant high-grade Glioma being conducted at Stanford Cancer Institute. The primary endpoint of the Phase II study is the six-week progression free survival (PFS) rate. Secondary endpoints include survival from time of first etirinotecan pegol infusion, overall survival from date ...

Phase III trials commence for OMS 103HP for Arthroscopic Surgery

Enrollment is complete in the first of two trials from Omeros Corporation, in patients undergoing arthroscopic partial meniscectomy Surgery. The Phase III clinical program for OMS 103HP is assessing the drug's safety and efficacy in improving postoperative joint function and reducing pain following arthroscopic partial meniscectomy surgery. The program is expected to consist of two randomized, double-blind, vehicle-controlled, multicenter trials. ...

Positive interim results for Embrace Advanced Scar Therapy (Neodyne Biosciences)

An interim analysis demonstrates the efficacy of the Embrace Advanced Scar Therapy System from Neodyne Biosciences, within one of the most challenging scar-prone surgical procedures, an abdominoplasty (tummy tuck). The results of the first 28 patients to complete the six month assessment showed a highly significant difference between the expert blinded assessments of scar appearance for the Embrace treated ...

Positive results for Humira (Abbott) for pediatric patients with Crohn's Disease

Humira (adalimumab), from Abbott, is effective in maintaining remission in pediatric patients with Crohn's disease, according to a new study in the journal Gastroenterology. This study is the largest double-blind study of an anti-TNF agent in children with Crohn's disease.

Researchers studied 192 patients, ages 6 to 17 years, across 45 sites in Canada, Europe and the US between ...

CytoFab (BTG/AstraZeneca) fails Sepsis trial

BTG disclosed top-line results from a Phase IIb study conducted by AstraZeneca which had compared two doses of CytoFab (polyclonal ovine anti-TNF antibody fragments) with a placebo in patients with severeSepsis and/or Septic Shock. Treatment with CytoFab failed to show any significant improvements versus placebo with regard to either the primary endpoint of ventilator-free days or secondary endpoints such as ...

EMA approves Votrient (Glaxo Smith Kline) for patients with Soft Tissue Sarcoma

The European Commission has granted marketing authorisation for the use of Votrient (pazopanib), from Glaxo Smith Kline, for treatment of patients with advanced Soft Tissue Sarcoma (aSTS) who have received prior chemotherapy or have progressed within 12 months after (neo) adjuvant therapy. Efficacy and safety has only been established in certain STS histological tumour subtypes. According to results of the ...

NICE rejects Iluvien(Alimera Sciences)for DME treatment

NICE (The National Institute for Health and Clinical Excellence) has now released a draft recommendation that does not back the use of the sustained-release intravitreal implant for the treatment of visual loss caused by chronic Diabetic Macular Edema (DME), NICE did not find the treatment cost-effective. This is a draft appraisal, and NICE expects to issue its final guidance in ...

Talactoferrin fails FORTIS-M trial for NSCLC

The FORTIS-M trial of talactoferrin from Aggenix AG, investigated the effect of talactoferrin plus best supportive care (BSC) compared with placebo and BSC in patients with Stage IIIb/IV Non Small Cell Lung Cancer, whose disease had progressed following two or more prior treatment regimens. Results showed that median overall survival in the talactoferrin arm was just 7.5 months compared to ...

Glaxo Smith Kline files NDA and MAA for dabrafenib in Metastatic Melanoma patients

Glaxo Smith Kline has filed a New Drug Application to the FDA for dabrafenib for the treatment of patients with unresectable or Metastatic Melanoma with BRAF V600 mutation as detected by an FDA-approved test. The company has also filed a Marketing Authorisation Application to the EMA for dabrafenib for treating adult patients with the same mutation. This follows positive results ...

NICE recommends Procoralan (Servier) for treatment of Chronic Heart Failure

Procoralan (ivabradine) from Servier Labs has been recommended by NICE in draft guidance as a treatment option for people with Chronic Heart Failure. The treatment has been recommended in combination with standard therapy or when beta-blocker therapy is contraindicated or not tolerated, after impressing in clinical trials....

Phase III development of bapineuzumab (Janssen Alzheimer Immunotherapy) in Alzheimer's disease discontinued

Janssen Alzheimer Immunotherapy has announced that its Phase III clinical development of bapineuzumab intravenous (IV) in mild-to-moderate Alzheimer's disease is being discontinued. This is based on the co-primary clinical endpoints not being met in the Janssen AI-led Studies 301 and 302. Four placebo-controlled Phase III studies comprised the bapineuzumab clinical development program. Janssen AI led the two completed 18-month, Phase ...

GSK files trametinib at the FDA for Metastatic Melanoma

GSK has filed trametinib, a drug developed by Japan Tobacco , at the FDA to treat unresectable Metastatic Melanoma and is planning a EU filing. The molecule targets patients with BRAF V600 mutation positive forms of Metastatic Melanoma. The V600 mutation applies to some 60% of Melanoma patients. A companion diagnostic has already been filed by BioMerieux. The application is ...

Updated results of TIVO-1 study of tivozanib in Renal Cell Carcinoma

Aveo Pharma and Astellas reported detailed data from TIVO-1 (Tivozanib Versus Sorafenib in 1st line RCC), a global, randomized, Phase III, superiority clinical trial evaluating the efficacy and safety of tivozanib compared to sorafenib in 517 patients with advanced Renal Cell Carcinoma (RCC). The data showed that tivozanib successfully demonstrated superiority over sorafenib in the primary endpoint of progression-free ...

Combination Faslosdex and Arimidex success in Breast Cancer trial

A report in 2 August issue of NEJM recorded that a combination of Arimidex ( anastrozole) and oestrogen receptor modulator Faslodex (fluvestrant) is more effective than either Arimidex or Faslodex alone or sequentially administered in treating post menopausal hormone recepttor (HR) positive metastatic breast cancer. Combination therapy gave a signiicant improvement in secondary endpoint of overall survival by more than ...

FDA approves generic Singulair for Asthma

The FDA has approved the first generic versions of Singulair (montelukast sodium)from AstraZeneca for use in adults and children to control Asthma symptoms and to help relieve symptoms of indoor and outdoor allergies. Apotex Inc., Aurobindo Pharma, Endo Pharmaceuticals, Glenmark Generics, Kudco Ireland Inc., Mylan Inc., Roxane Laboratories, Sandoz Inc., Teva Pharmaceuticals Inc., and Torrent Pharmaceuticals have gained FDA approval ...

FDA approves Zaltrap ( Regeneron/Sanofi) for treatment of metastatic Colorectal Cancer

The FDA has approved Zaltrap (ziv-aflibercept) from Regeneron/ Sanofi for use in combination with a FOLFIRI (folinic acid, fluorouracil and irinotecan) chemotherapy regimen to treat adults with Colorectal Cancer. Zaltrap is an angiogenesis inhibitor that inhibits the blood supply to tumors. It is intended for patients whose cancer has spread to other parts of the body (metastatic) and whose tumors ...

ARRAY-797 (Array Biopharma) reports Phase II results in Osteoarthritis

ARRAY-797 from Array Biopharma met its primary endpoint in a randomized, placebo-controlled and active-controlled (oxycodone ER) Phase II clinical trial in 157 Osteoarthritis patients suffering from moderate to severe knee pain despite the use of non-steroidal anti-inflammatory drugs (NSAIDs). Patients in all treatment groups continued using NSAIDs throughout the trial.The investigational compound, ARRY-797, is a novel, oral, selective p38 ...

FDA issues Complete Response Letter for HyQ (Baxter) for treatment of Primary Immunodeficiencies

The FDA has issued a complete response letter for HyQ, an investigational combination immunoglobulin product from Baxter for the treatment of patients with Primary Immunodeficiencies that includes Immune Globulin (IG) Infusion 10% (Human) and Recombinant HumanHyaluronidase. The letter requested additional preclinical data to support the biologics license application. The primary issues raised in the letter focused on non-neutralizing antibodies generated ...

FDA issues Complete Response Letter relating to Abilify Depot (Otsuka/Lundbeck) for monthly treatment of Schizophrenia

Lundbeck A/S and Otsuka Pharmaceutical Co., Ltd. have announced receipt of a Complete Response Letter from the FDA to the New Drug Application (NDA) for the investigational intramuscular (IM) depot formulation of Abilify (aripiprazole). In the letter, the only issue FDA cited was deficiencies from a recent inspection of a third-party supplier of sterile water....

FDA requires more data for Arcalyst (Regeneron) for Gout Flares treatment

The FDA has again issued a Complete Response Letter for the supplemental Biologics License Application for Arcalyst (rilonacept) from Regeneron for subcutaneous use for the prevention of Gout Flares in patients initiating uric acid-lowering therapy. The agency has requested additional clinical data, as well as additional chemistry, manufacturing and controls information related to a proposed new dosage form....

Hemispherx files response to FDA for Ampligen treatment of Chronic Fatigue Syndrome

Hemispherx Biopharma filed its complete response to the FDA’s November 25, 2009 Complete Response Letter in support of the New Drug Application for Ampligen for Chronic Fatigue Syndrome (“CFS”). As previously reported, at a recent meeting with the Agency, Hemispherx reached agreement on the filing. The FDA has indicated that the new submission will be reviewed on a 6 month ...

Trial of Symphony tCGM glucose monitoring in Critical Care

Echo Therapeutics, Inc. announced positive results from its clinical trial of the Symphony tCGM System in major general surgery and cardiothoracic surgery patients. This study is the second of two studies in critically ill patients. Data from this study demonstrate that Symphony successfully and continuously monitored glucose levels in the intensive care unit at Thomas Jefferson University Hospital in Philadelphia, ...

EU approves Humira (Abbott) for treatment of Axial Spondyloarthritis

Abbott has announced that the European Commission (EC) has approved Humira(adalimumab) for the treatment of adults with severe Axial Spondyloarthritis (axSpA) who have no X-ray evidence of structural damage. Humira is the first and only approved medication available for non-radiographic axSpA patients (nr-axSpA). This approval marks the eighth indication for Humira in the European Union since the product's first approval ...

FDA will review cabozantinib (Exelixis Inc) as a treatment for Thyroid Ccancer on 29 November 2012

Exelixis, Inc.announced that the FDA has accepted for filing the New Drug Application (NDA) for cabozantinib as a treatment for patients with progressive, unresectable, locally advanced, or metastatic medullary Thyroid Cancer (MTC). The FDA also granted priority review designation to the NDA for cabozantinib. The Prescription Drug User Fee Act (PDUFA) action date is November 29, 2012....

NuPathe re-files transdermal Migraine patch at FDA

FDA has accepted for review the resubmitted new drug application for the transdermal sumatriptan migraine patch NP101 fom NuPathe. The FDA has set 17 January as the new Prescription Drug User Fee Act action date.This will be the first transdermal patch for Migraine ever reviewed by the agency....

ORAL Start trial success for tofacitinib (Pfizer) in RA

ORAL Start is an ongoing two-year study in methotrexate (MTX)-naïve patients with moderate-to-severe active Rheumatoid Arthritis (RA), randomized to receive tofacitinib 5 or 10 mg twice-daily (BID) from Pfizer, as monotherapy or MTX, met its primary endpoints at both the 5 and 10 mg BID doses. Tofacitinib was found to be superior to MTX with statistically significant changes shown ...

Serada (Depomed) filed at FDA for treatment of Hot Flashes

Depomed Inc., has submitted a New Drug Application (NDA) for Serada (gabapentin GR) to the FDA. Serada is a proprietary extended release formulation of gabapentin in development for the treatment of Menopausal Hot Flashes....

Zetonna (Sunovion) launched in US for Allergic Rhinitis

Sunovion Pharmaceuticals Inc. announced the nationwide US availability of Zetonna (ciclesonide) Nasal Aerosol, 74 mcg once-daily, for the treatment of allergic rhinitis (AR), also known as hay fever or nasal allergies. Zetonna is a corticosteroid indicated for the treatment of symptoms associated with seasonal allergic rhinitis (SAR) and perennial allergic rhinitis (PAR) in adults and adolescents 12 years of age ...

EU approves Afinitor (Novartis)for the treatment of hormone receptor-positive (HR+), HER2/neu-negative (HER2-) advanced Breast Cancer

The European Commission has approved Afinitor (everolimus) tablets from Novartis for the treatment of hormone receptor-positive (HR+), HER2/neu-negative (HER2-) advanced Breast Cancer (HR+ advanced breast cancer), in combination with exemestane, in postmenopausal women without symptomatic visceral disease after recurrence or progression following a non-steroidal aromatase inhibitor.

The approval was based on the Phase III BOLERO-2 (Breast cancer trials of ...

Takeda re-submits Nesina and Nesina plus Actos at FDA for Type 2 Diabetes

Takeda has re-filed new drug applications at the FDA for its antidiabetic Nesina (alogliptin) and a fixed-dose combination of the dipeptidyl peptidase IV inhibitor with pioglitazone (Takeda's Actos).Updated additional postmarketing data from outside the US (from Japan) and significant new data from three Phase III studies in its ongoing global clinical trial programme had been included in the resubmissions....

EC approves Eklira/Bretaris Genuair (Almirall/Menarini) for treatment of COPD

Almirall has announced that the European Commission has granted marketing approval to Eklira/Bretaris Genuair(aclidinium 322µg twice daily) in all EU member states, plus Iceland and Norway, as a maintenance bronchodilator treatment to relieve symptoms in adult patients with Chronic Obstructive Pulmonary Disease (COPD).

Clinical efficacy studies showed that aclidinium provides around the clock significant and sustained bronchodilation ...

Phase II proof of concept trial for APG 101 (Apogenix) is confirmed for Glioblastoma Multiforme

Apogenix announced the figures that confirm that the primary objective of its Phase II proof-of-concept trial investigating its lead product, APG101, as a second line treatment of Glioblastoma Multiforme (GBM), had been met, The company expects to unveil overall survival data from the study in the fourth quarter of 2012.In March 2012 the company reported that the primary objective of ...

FDA Advisory Committee recommends ocriplasmin(Thrombogenics) for treatment of Vitreomacular Adhesions

ThromboGenics NV announced that the FDA Dermatologic and Ophthalmic Drugs Advisory Committee has recommended that the FDA grant ocriplasmin approval for the treatment of symptomatic Vitreomacular Adhesion (VMA). The Committee voted 10 to 0 at its meeting that the benefits of administering ocriplasmin for the treatment of vitreomacular adhesions outweigh the potential risks.Symptomatic VMA is a progressive condition that if ...

Early results for E 2609 (Eisai) in Alzheimers Disease

Eisai has disclosed the first clinical data (Phase 1) for its new early stage candidate for Alzheimer's disease, the beta-site amyloid precursor protein-cleaving enzyme (BACE1) inhibitor E 2609. Results from healthy adult volunteers presented to the 2012 Alzheimer's Association International Conference in Vancouver, Canada, showed that E 2609 reduced plasma levels of amyloid-beta by up to 92% relative to baseline ...

EU approves Fycompa (Eisai) for treatment of Epilepsy

The European Commission has granted marketing authorisation approval for the use of Fycompa (perampanel) from Eisai as an adjunctive treatment of partial-onset seizures, with or without secondarily generalised seizures, in people with Epilepsy aged 12 years and older.The FDA issued a refusal to file letter for perampanel in July 2011, following a preliminary review of the acceptability of the original ...

FDA requests further data in review of Relistor (Salix) for Opioid-induced Constipation

The FDA have provided a Complete Response Letter (CRL) following its review of a Supplemental New Drug Application (sNDA) for Relistor (methylnaltrexone bromide), from Salix, for the treatment of Opioid-induced Constipation in adult patients with chronic, non-cancer pain. The CRL requests additional clinical data. Salix and Progenics intend to request an End-of-Review meeting with the Division of Gastroenterology and Inborn ...

Study shows Cinryze (Viro Pharma) effective for long-term treatment of Hereditary Angio-oedema

New results demonstrate that routine prophylactic use of Cinryze (C1 esterase inhibitor), from Viro Pharma, provided effectiveness and maintained a generally favorable safety profile in the majority of treated subjects with Hereditary Angio-oedema. Treated with Cinryze 1000 units every 3 to 7 days, subjects experienced a 93.7 percent reduction in attacks while taking prophylactic Cinryze (median of 0.19 attacks per ...

FDA approves CorPath 200 (Corindus Inc) robotic-assisted system for PCI

The FDA has given 510(k) clearance for the CorPath 200 System, from Corindus Inc, to be used in Percutaneous Coronary Interventions (PCI). The technology is now approved in the US to assist interventional cardiologists in performing PCI, a procedure to restore blood flow to blocked arteries in patients with Coronary Artery Disease (CAD).

The CorPath PRECISE Trial—a prospective, single-arm, ...

Ecopipam (Psyadon Pharmaceuticals) success in Phase II study for Tourette Syndrome

Psyadon Pharmaceuticals, Inc. announced that its Phase II study of ecopipam in patients with Tourette Syndrome was stopped early when a planned interim analysis revealed a statistically significant reduction in the severity of the patients' tic symptoms. This decision was supported by both the independent Drug Safety and Monitoring Committee overseeing the study and by the external Research Committee established ...

EMA award orphan status to A 4250 (Albireo) for the treatment of Primary Biliary Cirrhosis

The European Medicines Agency Committee for Orphan Medicinal Products (COMP) has issued a positive opinion on an application for orphan medicinal product status for A 4250, from Albireo, for the treatment of Primary Biliary Cirrhosis (PBC), Progressive Familial Intrahepatic Cholestasis (PFIC) and Alagille Syndrome. A 4250 belongs to a class of inhibitors of the ileal bile acid transporter (IBAT, syn. ...

EU approves Jentadueto (Boehringer) for patients with Type 2 Diabetes

The EU has approved Jentadueto (linagliptin plus metformin), from Boehringer, for use alongside diet and exercise to improve glycaemic control in adults with Type 2 Diabetes who are inadequately controlled on their maximal tolerated dose of metformin alone, metformin and a sulphonylurea, or those already being treated with the combination of linagliptin and metformin. It may also be used ...

FDA approve Magnatom Spectra 3T MRI imaging system (Siemens)

The FDA has approved the Magnetom Spectra 3 Tesla MRI system, from Siemens. The new system employs Tim (Total imaging matrix) 4G technology – Siemens' latest coil generation that provides improved imaging accuracy and flexibility. The array structure allows for high spatial and temporal resolution, which, along with a high-signal-to-noise ratio, enables Tim 4G to deliver improved image quality. The ...

Sanofi Pasteur Dengue vaccine success in clinical trial

Sanofi Pasteur, the vaccines division of Sanofi announced that its tetravalent Dengue Vaccine candidate demonstrated proof of efficacy against Dengue, a threat to almost 3 billion people, in the world’s first ever dengue efficacy trial conducted in Thailand, with excellent safety. The vaccine generated antibody response for all four dengue virus serotypes. Evidence of protection was demonstrated against three of ...

FDA approves Tudorza Pressair ( Forest Pharma) for COPD

The FDA on 23 July 2012 approved Tudorza Pressair (aclidinium bromide) from Forest Pharma for the long-term maintenance treatment of bronchospasm (narrowing of the airways in the lung) associated with Chronic Obstructive Pulmonary Disease (COPD), including chronic bronchitis and emphysema. The safety and efficacy of Tudorza Pressair were demonstrated in three randomized, placebo-controlled confirmatory clinical trials that included 1,276 patients ...

Phase III study of bapineuzumab (Janssen Alzheimer Immunotherapy) for Alzheimers Disease fails to meet endpoint

In a Phase III trial of intravenous bapineuzumab, from Janssen Alzheimer Immunotherapy, in patients with mild-to-moderate Alzheimer’s disease who carry the ApoE4 genotype (Study 302), the co-primary clinical endpoints, change in cognitive and functional performance compared to placebo, were not met. Study 302 is the first of four placebo-controlled Phase III studies to complete in the development of bapineuzumab IV. ...

Sarepta Therapeutics success with eteplirsen in Phase IIb trial for Duchenne Muscular Dystrophy

Sarepta Therapeutics (formerly AVI Pharma), the developer of innovative RNA-based therapeutics, announced that treatment with its exon-skipping compound, eteplirsen, achieved a significant clinical benefit on the primary clinical outcome, the 6-minute walk test (6MWT), over a placebo/delayed treatment cohort in a Phase IIb trial in Duchenne Muscular Dystrophy (DMD) patients. Eteplirsen administered once weekly at 50mg/kg over 36 weeks ...

Two Phase III studies of OMS ElectroChemotherapy (OncoSec Medical) show QoL benefits

Data from an interim analysis of two Phase III trials, HNBE-01 and HNBE-02, using OMS ElectroChemotherapy, from OncoSec Medical, to treat locally recurrent and second primary squamous cell carcinoma of the head and neck enhances patients quality of life.

In these studies, electrochemotherapy was compared against surgery for quality of life, safety, survival and local control at eight months, ...

Lyrica (Pfizer) success in GAD discontinuation symptoms

Pfizer announced top-line results for Lyrica (pregabalin) capsules Study A0081147 – Long Term Safety and Efficacy of Pregabalin in Subjects with Generalized Anxiety Disorder (GAD) –which demonstrate that drug discontinuation symptoms were low after tapering Lyrica treatment following three months and six months in GAD patients. The European Medicines Agency (EMA) requested this study to investigate the relationship between dose ...

No benefit of Tarceva (Genentech/Roche) for patients with Liver Cancer

A Phase III trial evaluating the efficacy and safety of the addition of Tarceva (erlotinib), from Genentech/Roche, to sorafenib did not improve overall survival for patients with unresectable Liver Cancer vs. sorafenib alone. The international SEARCH trial randomised 720 patients with advanced Liver Cancer and examined whether the addition of Tarceva to sorafenib prolongs survival as compared to sorafenib alone ...

Positive results from Phase III study of Isentress (Merck Inc) for HIV-1 patients

Final results from the STARTMRK study, a Phase III trial evaluating Isentress (raltegravir), from Merck Inc, in combination therapy in previously untreated adult HIV-1 patients, indicate that virologic efficacy was better than the efavirenz-based regimen at 240 weeks. In the study, 563 previously untreated HIV-1 infected adult patients with HIV-1 RNA greater than 5000 copies/mL received either 400 mg Isentress ...

South Korea approves first biosimilar Remsima from Celltrion to compete with Remicade

South Korea has granted the first approval worldwide to a biosimilar version of Johnson & Remicade (infliximab) from Johnson & Johnson/Merck Inc. ).The regulatory clearance is for Remsima (CT-P13) from Celltrion and is also the first to be given anywhere to a biosimilar monoclonal antibody.Remsima may also be launched by the end of the year in a number of Asian ...

Vestiq Pharma licenses Oravig for Oropharyngeal Candidiasis in US from BioAlliance Pharma

BioAlliance Pharma has entered into a licence agreement with Vestiq Pharmaceuticals, under which the latter gains the US commercialisation rights to the antifungal treatment, Oravig (miconazole), for oropharyngeal candidiasis in adults.Following PAR Strativa restructuring and change of its strategy including the acquisition of generic portfolio, BioAlliance Pharma had decided to regain full US commercialisation rights for Oravig in October 2011.In ...

CHMP recommends Adcetris ( Takeda) for CD 30+ Hodgkin Lymphoma

On 19 July 2012, the CHMP adopted a positive opinion, recommending the granting of a conditional marketing authorisation for the medicinal product Adcetris (brentuximab vedotin) from Takeda/Millennium/Seattle Genetics, 50 mg, powder for concentrate for solution for infusion, intended for the treatment of of adult patients with relapsed or refractory CD30+ Hodgkin Lymphoma (HL): (1) following autologous stem cell transplant (ASCT) ...

CHMP recommends Dacogen (Janssen/Eisai) for Acute Myeloid Leukemia

On 19 July 2012, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Dacogen, 50 mg, powder for concentrate for solution for infusion, from Eisai/Janssen and intended for the treatment of Acute Myeloid Leukaemia. Dacogen was designated as an orphan medicinal product on 8 June ...

CHMP recommends Glybera (uniQure) gene therapy for LPLD

uniQure announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion that recommends marketing authorization of Glybera (alipogene tiparvovec) as a treatment for Lipoprotein Lipase Deficiency (LPLD) under exceptional circumstances. LPLD is a very rare, inherited disease. Patients with the disease are unable to handle fat particles in their blood plasma, ...

CHMP recommends Xalkori (Pfizer) for treatment of NSCLC

On 19 July 2012, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a conditional marketing authorisation for the medicinal product Xalkori (crizotinib), 200 mg, 250 mg, hard capsule from Pfizer and intended for the treatment of adults with previously treated anaplastic lymphoma kinase (ALK)-positive advanced Non-Small Cell Lung Cancer (NSCLC) . ...

CHMP refuses recommendation of Istodax( Celgene) for T-cell Lymphoma

On 19 July 2012, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a conditional marketing authorisation for the medicinal product Xalkori (crizotinib), 200 mg, 250 mg, hard capsule from Pfizer and intended for the treatment of adults with previously treated anaplastic lymphoma kinase (ALK)-positive advanced Non-Small Cell Lung Cancer (NSCLC) . ...

Namenda (Merz) positive in Down's Syndrome trial

Researchers have found that Namenda (memantine)from Merz boosts memory function in those with Down's Syndrome, a major milestone in the treatment of this genetic disorder that could significantly improve quality of life. They studied 38 adolescents and young adults with Down's Syndrome. Half took the drug memantine, used to treat Alzheimer's disease, and the others took a placebo. Participants ...

ODYSSEY Phase III trials enroll for SAR 236553 treatment of LDL Cholesterol

Sanofi and Regeneron Pharmaceuticals, Inc. announced that several trials within ODYSSEY, the Phase III clinical program of SAR236553/REGN727, have initiated patient enrollment. SAR236553/REGN727 is a potential first-in-class, subcutaneously administered, fully-human antibody that lowers low-density lipoprotein (LDL) cholesterol by targeting PCSK9 (proprotein convertase subtilisin/kexin type 9), an enzyme which binds LDL receptors, leading to their accelerated degradation and increased LDL-cholesterol (LDL-C) ...

AutoRIC (CellAegis) receives CE mark for AMI patients

CellAegis has received a CE Mark for its autoRIC device, which allows simple automation of remote ischemic conditioning (RIC) at the point of care for patients with Acute Myocardial Infarction. CellAegis' autoRIC Device has been developed for acute care applications in the ambulance, emergency room and other hospital settings, or for chronic treatment in the home. Remote ischemic conditioning uses ...

Brivanib (BMS) fails Phase III trial for Hepatocellular Carcinoma

Bristol Myers Squibb (BMS) announced the results of the phase III BRISK-FL clinical trial of the investigational agent brivanib versus sorafenib as first-line treatment in patients with advanced Hepatocellular Carcinoma (liver cancer). The study did not meet its primary overall survival objective based upon a non-inferiority statistical design. BMS is considering options for the ongoing brivanib development program. Ongoing clinical ...

FDA approves Afinitor for HER-2 negative Breast Cancer

The FDA has approved Afinitor (everolimus)tablets from Novartis for the treatment of postmenopausal women with advanced hormone receptor-positive, HER2-negative Breast Cancer (advanced HR+ breast cancer) in combination with exemestane after failure of treatment with letrozole or anastrozole. The approval was based on a randomized, double-blind, placebo-controlled, multi-center trial called BOLERO-2 (Breast cancer trials of OraL EveROlimus-2), which evaluated 724 postmenopausal ...

FDA approves Kyprolis (Onyx Pharma) for Multiple Myeloma

The FDA has approved Kyprolis (carfilzomib) from Onyx Pharma to treat patients with Multiple Myeloma who have received at least two prior therapies, including treatment with Velcade (bortezomib) and an immunomodulatory therapy. A form of blood cancer that arises from plasma cells, Multiple Myeloma usually grows in bone marrow, the soft, spongy tissue found inside most bones. The bone marrow ...

Selzentry/Celsentri(ViiV) in trial for HIV Prevention

The first clinical trial to test whether drug regimens containing Selzentry/Celsentri (maraviroc) from Viiv HealthCare, are also safe and tolerable when taken once daily by HIV-uninfected individuals at increased risk for acquiring HIV infection. The eventual goal is to see if the drug regimens can reduce the risk of infection. The trial involves a strategy known as pre-exposure prophylaxis, or ...

EVP 6124 (EnVivo Pharma)success in Phase IIb Alzheimers Disease trial

EnVivo Pharmaceuticals, announced positive results from its Phase IIb clinical trial of EVP-6124, a novel alpha-7 agonist, in patients with Alzheimer's Disease during an oral presentation at the Alzheimer's Association International Conference 2012 being held in Vancouver, British Columbia. The six-month, double-blind Phase IIb clinical trial evaluated EVP-6124 against placebo in patients with mild to moderate Alzheimer's Disease. The EVP-6124 ...

Pfizer files Aprela at EMA for Oestrogen Deficiency Symptoms

The European Medicines Agency (EMA) accepted for review the Marketing Authorization Application (MAA) for bazedoxifene/conjugated estrogens (BZA/CE) from Pfizer, a potential new medicine for postmenopausal women with a uterus for the treatment of Estrogen Deficiency Symptoms and treatment of Osteoporosis in women at risk of fracture. Pfizer expects a decision from the European Commission in 2013. BZA/CE pairs the selective ...

Brilinta/Brilique(AstraZeneca) study in Peripheral Vascular Disease

Astra Zeneca will commence a new study called EUCLID of Brilinta/Brilique(ticagrelor) to compare twice daily dosing of Brilinta/Brilique with once dosing daily of now generic Plavix (clopidogrel) in 11 500 patients with Peripheral Vascular Disease....

Early results from Phase II study of Gammagard Liquid 10%(Baxter) for Alzheimers Disease

Baxter International presented three-year data on 16 patients in the Phase II study of Gammagard, which originally enrolled 24 participants. Overall, all 11 study participants who received Gammagard for the full three years showed improvements in thinking abilities, behavior and daily functioning.Of these, the four patients who received the most effective dose (0.4g/kg) for the full 36 months fared the ...

EMA approves Axios Stent system (Xlumena) for GI surgery

The EU has given CE Mark approval to market the Axios Stent and Delivery System, from Xlumena, for biliary tract drainage in GI Surgery. The Axios system gives endoscopists a minimally-invasive tool to create a secure connection between the gallbladder or bile duct and the gastrointestinal tract. The Axios Stent is delivered under endoscopic ultrasound guidance using a specially-designed delivery ...

FDA accepts filing of Zohydro ER for Chronic Pain treatment

The FDA has accepted for review the new drug application (NDA) for the oral, extended-release hydrocodone therapy ZohydroER from Zogenix Inc., as a treatment for moderate to severe Chronic Pain.The FDA set 1 March 2013 as the Prescription Drug User Fee Act action date – granting a 10-month standard review....

FDA approves Qsymia (Vivus Inc.) treatment for Obesity

The FDA has approved Qsymia (phentermine and topiramate extended-release) formerly Qnexa from Vivus Inc., as an addition to a reduced-calorie diet and exercise for chronic weight management. The drug is approved for use in adults with a body mass index (BMI) of 30 or greater (obese) or adults with a BMI of 27 or greater (overweight) who have at ...

Laquinomod (Active Biotech/Teva) is filed at EMA for Multiple Sclerosis

Active Biotech/Teva has announced that the European Medicines Agency (EMA) has completed the validation process for the marketing authorization application of laquinimod for the treatment of relapsing-remitting Multiple Sclerosis.The submission is supported by a pooled analysis of data from the two global Phase III clinical trials in RRMS involving more than 2,400 patients treated for two years, the ALLEGRO and ...

Simponi(Janssen Biotech) filed at FDA and EMA for Ulcerative Colitis treatment

Janssen Biotech and Janssen Biologics have requested the FDAand European Medicines Agency to approve Simponi(golimumab) a treatment for "adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy." Simponi ,a once-monthly subcutaneously administered drug , received approvals in the United States, Europe and Canada in 2009 for the treatment of moderately to ...

Stem cells improve memory for Alzheimers Disease

Preclinical data showed that human neural stem cells from Stem Cells Inc.restored and improved memory in animal models of Alzheimer's Disease without affecting amyloid beta or delta tau, two key proteins targeted by therapeutics in pharmaceutical development. The study results were presented at the Alzheimer’s Association International Conference in Vancouver, Canada and represent the first time human neural stem cells ...

Update recommends Brilinta (AstraZeneca) for Heart Attack patients

Brilinta/Brilique (ticagrelor), from AstraZeneca, should be considered along with older blood thinners clopidogrel and prasugrel for treating patients who are experiencing chest pain or some Heart Attacks, according to joint updated guidelines issued by the American Heart Association (AHA) Task Force on Practice Guidelines and the American College of Cardiology (ACCF) Foundation.

The “focused update” on unstable angina ...

FDA approves Truvada(Gilead Sciences) for HIV Prevention

The FDA has approved Truvada (emtricitabine/tenofovir disoproxil fumarate) from Gilead Sciences, the first drug approved to reduce the risk of HIV infection in uninfected individuals who are at high risk of HIV infection and who may engage in sexual activity with HIV-infected partners. Truvada, taken daily, is to be used for pre-exposure prophylaxis (PrEP) in combination with safer sex practices ...

Neupro (UCB/Schwarz) re inrroduced in US for RLS and Parkinsons Disease

Neupro(rotigotine transdermal patch) from UCB/Schwarz is now available again in the US after getting release from the FDA in April to treat the signs and symptoms of early and advanced stage idiopathic Parkinsons Disease and moderate-to-severe primary Restless Legs Syndrome. Neupro is a once-daily patch that provides continuous delivery of the dopamine agonist rotigotine for 24 hours. The treatment was ...

Eisai applies to EMA to extend use of Zonegran to children for treatment of partial seizures

The EMA has accepted the submission of an application to extend the use of Epilepsy drug Zonegran (zonisamide), from Eisai, in the treatment of partial seizures (with or without secondary generalisation) to include children aged six years and above. A decision on this new licence extension application is expected in September 2012.

This submission was based on data from ...

Fluticasone/vilanterol combination (GSK) is filed in US for COPD and in the EU for Asthma and COPD

GSK and Theravance announced the submission of regulatory applications in the US and European Union for the once-daily investigational medicine Relovair( fluticasone furoate /vilanterol).

In the European Union the application is for patients with Chronic Obstructive Pulmonary Disease (COPD) and an application for Asthma. The Marketing Authorisation Application for the European Union for the combination has a new proposed ...

Apremilast (Celgene) success in Phase III study of Psoriatic Arthritis

Top-line results are reported by Celgene from the PALACE-1 study, the first of three pivotal Phase III, randomized, placebo-controlled studies evaluating apremilast, the novel, oral small-molecule inhibitor of phosphodiesterase 4 (PDE4) in patients with Psoriatic Arthritis who had received an oral disease-modifying antirheumatic drug biologic therapy or had failed on an anti-tumor necrosis factor agent. Apremilast treatment in this study ...

Phase III trial for Odanacatib(Merck Inc.) in Osteoporosis closes early

A Phase III randomized, placebo-controlled trial with over 16,000 patients is designed to assess the safety and efficacy of odanacatib (from Merck Inc.) in reducing fracture risk in post-menopausal women with Osteoporosis. This event-driven trial started in 2007 and was expected to continue until hip fractures had been reported in a total of 237 patients. The Data Monitoring Committee ...

Phase III trial for Odanacitib(Merck Inc.) in Osteoporosis closes early

A Phase III randomized, placebo-controlled trial with over 16,000 patients is designed to assess the safety and efficacy of odanacatib (from Merck Inc.) in reducing fracture risk in post-menopausal women with Osteoporosis. This event-driven trial started in 2007 and was expected to continue until hip fractures had been reported in a total of 237 patients. The Data Monitoring Committee ...

Positive data from Phase III SUMMIT trial of MACI (Genzyme/Sanofi) for cartilage repair

New results show that MACI (matrix-induced autologous chondrocyte implant), from Genzyme/Sanofi, met its co-primary endpoint in a two-year, randomized, controlled clinical trial compared to microfracture, a surgical procedure designed to stimulate the growth of new cartilage.

The pivotal safety and efficacy Phase III trial (SUMMIT) enrolled 144 patients across seven countries in Europe with symptomatic articular cartilage defects in ...

Positive results from Phase III trial of PA21 (Vifor Pharma) for controlling Hyperphosphataemia

The pivotal Phase III clinical study shows that PA21 (iron oxyhydroxide), from Vifor Pharma, successfully controls Hyperphosphataemia in patients with chronic Kidney Disease on dialysis. Results of the 6-month, study with more than 1,000 patients conducted in the USA, Europe as well as in Russia, Ukraine and South Africa established the superiority of maintenance doses of PA21 versus a PA21 ...

Review shows some benefit from Avastin (Genentech/Roche) for Breast Cancer patients

A new review finds that Avastin (bevacizumab), from Genentech/Roche, offers modest benefit in slowing disease progression in advanced-stage Breast Cancer patients. The study examined Avastin's efficacy when combined with conventional chemotherapy treatment, but no overall improvement in survival was noted using this combination.

The review examined seven trials involving 4,032 patients with Breast Cancer and found that adding ...

Success in Phase III SINGLE trial of Dolutegravir

Interim results from the Phase III SINGLE study involving dolutegravir from Shionogi-Viiv HealthCare,demonstrated superiority of the dolutegravir-based regimen compared to the single tablet regimen Atripla. At 48 weeks, 88% of study participants on the dolutegravir regimen were virologically suppressed (<50 copies/mL) vs. 81% of participants on the single tablet regimen Atripla: The difference in the primary endpoint was statistically significant. ...

Final results from trial of Truvada (Gilead Sciences) for HIV Prevention

Final results from the FEM-PrEP HIV-prevention trial of Truvada (emtricitabine/tenofovir disoproxil fumarate), from Gilead Sciences, reinforce the key role of adherence in HIV Prevention studies and the need to determine better approaches to support adherence in future pre-exposure prophylaxis (PrEP) programs. Despite targeted counseling and support, adherence to the drug regimen was low, suggesting that women in the clinical trial ...

Syncria (GSK) superior to Januvia in HARMONY 8 study in Renally Impaired Diabetes patients

The Harmony 8 study is a 52-week randomised, double-blind, active-controlled, parallel-group, multicenter study, which is comparing Syncria (albiglutide) from GSK to Januvia (sitagliptin), a DPP-4 inhibitor marketed by Merck & Co, in 507 Type 2 Diabetes patients with mild, moderate and severe renal impairment.

Patients were randomised to receive albiglutide (30mg weekly with up-titration to 50mg weekly based ...

FDA halts trials of IB 1001 (Inspiration Pharmaceuticals) for Haemophilia B

The FDA has placed a hold on clinical trials evaluating the safety and efficacy of IB 1001, an intravenous recombinant factor IX (rFIX), from Inspiration Pharmaceuticals, being investigated for the treatment and prevention of bleeding episodes in people with Haemophilia B. Trials have shown a higher proportion of individuals treated with IB 1001 have developed antibodies to proteins from the ...

Stryker withdraws Rejuvenate Modular and ABG II neck stem Hip Replacements

Patients have encountered Stryker hip replacement problems and developed symptoms similar to those seen in metal-on-metal hip replacement devices. Stryker Orthopaedics will voluntarily remove Rejuvenate and ABG II modular-neck stem hip replacemenrs and terminate global distribution of these products. The decision comes after continued post-market surveillance. Patients who received a Rejuvenate Modular or ABG II modular-neck stem are encouraged to ...

Eeva System (Auxogyn) shows positive results in trial for IVF

A new study shows that the Early Embryo Viability Assessment (Eeva) Test from Auxogyn is able to predict embryo advancement in IVF (In vitro fertilisation) treatment with a new level of accuracy. In a prospective multi-center cohort study of 160 patients and close to 1,800 embryos, the Eeva Test was able to predict blastocyst formation at the cleavage stage with ...

Benefit assessment finds slight advantage of Gilenya (Novartis) for adults with Multiple Sclerosis

The German Institute for Quality and Efficiency in Health Care (IQWiG) has carried out an early benefit assessment to see if Gilenya (fingolimod), from Novartis, offers added benefit compared with present standard therapy in patients with highly-active relapsing-remitting Multiple Sclerosis (RRMS). The assessment reports that adult patients with this form of the disease taking Gilenya experience fewer flu-like symptoms than ...

GSK/Theravance announce results of four Phase III studies of GSK 573719 plus vilanterol in COPD

GSK and Theravance announced results of four pivotal Phase III studies of GSK 573719 (umeclidunium bromide) ("UMEC"),a long acting muscarinic antagonist (LAMA) and vilanterol, a long acting beta agonist (LABA) ("VI") administered by dry powder inhaler for treatment of COPD.The results of the four pivotal phase III studies of UMEC/VI involved over 4,000 patients with chronic obstructive pulmonary disease (COPD). ...

FDA approves Erbitux(Eli Lilly/BMS)for first line combination treatment of Kras wild type EGFR expressing metastatic Colorectal Cancer

Erbitux (cetuximab), marketed by BMS/Eli Lilly in the U.S.,in combination with the chemotherapy regimen FOLFIRI (irinotecan, 5-fluorouracil, leucovorin) has been granted full approval by the FDA for the first-line treatment of patients with KRAS mutation-negative (commonly known as KRAS wild-type), epidermal growth factor receptor (EGFR)-expressing metastatic Colorectal Cancer (mCRC) as determined by FDA-approved tests for this use. ERBITUX is not ...

FDA approves Therascreen KRAS RGQ PCR Kit (Qiagen) for use with Colorectal Cancer patients

The FDA has given marketing approval for the Therascreen KRAS RGQ PCR Kit, from Qiagen, to provide guidance on the use of Erbitux (cetuximab) as a treatment in patients with metastatic Colorectal Cancer. The Therascreen KRAS RGQ PCR Kit is a molecular diagnostic kit for detection of 7 somatic mutations in the KRAS gene using real-time PCR on the Rotor-Gene ...

Gilead Sciences files cobicistat"booster" for AIDS drugs

Gilead Sciences, announced it has submitted a New Drug Application (NDA) to the FDA for marketing approval of cobicistat, a pharmacoenhancing or “boosting” agent that increases blood levels of certain commercially available protease inhibitors, including atazanavir and darunavir, in order to enable once-daily dosing. Cobicistat is also a component of the Quad once-daily single tablet regimen for HIV, which is ...

Janssen Cilag withdraws application at EMA for Velcade in Follicular Lymphoma

Janssen Cilag has withdrawn its application for EU approval for the use of Velcade (bortezomib) in combination with rituximab as a treatment for patients with relapsed Follicular non-Hodgkin Lymphoma. The European Medicines Agency said it had been formally notified by the company that it was withdrawing the application because the Committee for Medicinal Products for Human Use indicated that the ...

AG200-15 (Agile Therapeutics) contraceptive patch filed at FDA

Agile Therapeutics has made a new drug application for its once-weekly, low-dose contraceptive patch, AG200-15,(ethinyl estradiol plus levonorgestrel) and the application was accepted for a standard 10-month review by the FDA. The FDA may make a decision by the first quarter of next year....

Erbitux (Merck Serono) fails EXPAND trial for Gastric Cancer

Merck Serono has announced the outcome of the Phase III clinical trial EXPAND, which assessed Erbitux (cetuximab) in combination with cisplatin and capecitabine as a 1st-line treatment for patients with advanced Gastric Adenocarcinoma including adenocarcinoma of the gastro-esophageal junction. The trial did not meet its primary endpoint of extending the length of time that patients live without their disease getting ...

Exembol (Mitsubishi Tanabe) launched in UK for HIT

Mitsubishi Tanabe Pharma's (MTP) has launched the direct thrombin inhibitor Exembol (argatroban) in the UK for the treatment of adult patients with Heparin-Induced Thrombocytopenia type II (HIT) who require parenteral antithrombotic therapy. Exembol is already launched in Netherlands, Germany/Austria/Scandinava and is marketed in the US by GSK....

Ferring licenses elobixibat from Albireo for Chronic Constipation and IBS.

Ferring has licensed from Albireo the world rights to elobixibat, excluding those territories held by Ajimoto. Elobixibat is a first-in-class investigational drug in development for Chronic Constipation and Irritable Bowel Syndrome with Constipation....

Phase II results positive for Prochymal (Osiris Therapeutics)following Myocardial Infarction

A Phase II, multi-center, randomized, double-blind, placebo-controlled study is evaluating the safety and efficacy of Prochymal (ex-vivo cultured adult human mesenchymal stem cells) intravenous infusion from Osiris Therapeutics, following acute myocardial infarction. A total of 220 patients were randomized (1:1) at 33 centers in the United States and Canada and received a single intravenous infusion of Prochymal or placebo within ...

Canagliflozin filed by Janssen Cilag in EU for Type 2 Diabetes

Janssen-Cilag has submitted an EU filing for canagliflozin, an oral, once-daily sodium glucose co-transporter 2 (SGLT2) inhibitor, for the treatment of adult patients with Type 2 Diabetes. Janssen R&D filed canagliflozin in the USA at the end of May 2012. Data from the first two head-to-head pivotal trials of canagliflozin showed that it has improved efficacy over established antidiabetics, without ...

Elvitegravir (Gilead Sciences) is filed at FDA for HIV-1 Infection in treatment-experienced adults

Elvitegravir,from Gilead Sciences, an integrase inhibitor for treatment for HIV-1 infection in treatment-experienced adults is filed at the FDA. The submission is supported by 96-week data from a pivotal Phase III 145 study, in which the drug dosed once daily at 150mg or 85mg was non-inferior to the integrase inhibitor raltegravir 400mg dosed twice daily – each administered with a ...

EMA approves Flutiform (Mundipharma) for Asthma treatment

The EMA has approved Flutiform (fluticasone plus formoterol), from Mundipharma, for the maintenance treatment of Asthma. This decision is binding on all 21 Concerned Member States involved in the decentralised procedure and the first national approvals of Flutiform are expected across a number of countries by the end of 2012. It is indicated for the regular treatment of Asthma in ...

FDA accepts filing of Hepislav ( Dynavax Technologies) vaccine for Hepatitis B

The FDA has accepted for review the biologics license application (BLA) for the Hepatitis B vaccine, Heplisav, from Dynavax Technologies. Hepislav is an immunostimulatory sequence targeting toll-like receptor 9 (TLR9) combined with hepatitis B surface antigen. The FDA set 24 February 2013 as the Prescription Drug User Fee Act action date for Heplisav. The attraction of Hepislav is an easier ...

FDA advisory panel does not recommend metal on metal hip replacement implants

The FDA asked an 18-member panel to recommend guidelines for monitoring more than a half-million U.S. patients with metal hip replacements. The devices were originally marketed as a longer-lasting alternative to older ceramic and plastic models. But recent data from the U.K. and other foreign countries suggests they are more likely to deteriorate, exposing patients to higher levels of cobalt, ...

FDA approves Healon EndoCoat OVD (Abbott Medical Optics) for use in Cataract extraction

The FDA has approved the use of Healon EndoCoat OVD, from Abbott Medical Optics, an ophthalmic viscosurgical device intended for use as a surgical aid in Cataract extraction and intraocular lens (IOL) implantation. This clear, viscous, protective gel formula is injected into a patient's eye to protect and coat the eye during surgery, reducing trauma to the inside layer of ...

FDA approves the Cobas TaqMan HIV-1 Test (Roche)

The FDA has approved the Cobas TaqMan HIV-1 Test, from Roche, which will be available in the US later this year. The test utilizes the FDA-approved High Pure System Viral Nucleic Acid Kit for manual specimen preparation and the COBAS TaqMan 48 Analyzer for automated amplification and detection. This one targets two highly conserved regions of the HIV-1 genome and ...

Ixazomib (Takeda/Millennium) enters Phase III trials for Multiple Myeloma

Takeda and Millennium Oncology have begun a Phase III development programme for ixazomib citrate (MLN 9708), the first oral proteasome inhibitor to enter clinical trials for Multiple Myeloma and to be a possible successor to the Velcade. The trial is TOURMALINE-MM1 which will assess MLN 9708 in patients with relapsed and/or refractory Multiple Myeloma at sites in North and South ...

New drug application filed with FDA for TMC 207 (Janssen Pharmaceuticals) for multi-drug resistant Tuberculosis

Janssen Pharmaceuticals has submitted a New Drug Application to the FDA seeking accelerated approval for the use of TMC 207 (bedaquiline) to be used as part of combination therapy for pulmonary, multi-drug resistant Tuberculosis (MDR-TB) in adults. If approved, it would be the first drug with a new mechanism of action for TB in more than 40 years and the ...

Positive data in study of Krystexxa (Savient Pharma) in patients with Gout

New results show that adult patients with refractory chronic Gout (RCG) treated bi-weekly with Krystexxa (pegloticase), from Savient Pharma, experienced statistically significant and clinically meaningful improvements in health-related quality of life (HRQOL), pain and physical function. The analysis evaluated patient-reported outcomes from two replicate, randomized, double-blind, placebo-controlled Phase III studies. Results at week 25 demonstrated that mean improvements from baseline ...

Two-year study of Tradjenta (Boehringer/Eli Lilly) shows reduced adverse effects in Type 2 Diabetes patients

A double-blind study which took place over two years in sixteen countries, examined the effects of Tradjenta (linagliptin), from Boehringer and Eli Lilly, versus glimepiride in more than 1,500 patients with Type 2 Diabetes who had not achieved normal glucose regulation through the use of metformin alone. The two treatments produced comparable improvements in patients' glucose regulation, but the study ...

FDA Advisory Committee recommends Lucentis (Genentech) for treatment of Diabetic Macular Edema

The FDA Dermatologic & Ophthalmic Drugs Advisory Committee (DODAC) voted unanimously (10-0) to recommend approval of the 0.3 mg dose of Lucentis (ranibizumab injection) from Genentech/Roche for treatment of Diabetic Macular Edema (DME). The FDA is expected to make a decision regarding the supplemental Biologics License Application (sBLA) for Lucentis in DME by August 10, 2012. The FDA generally follows ...

FDA approves Myrbetriq (Astellas) for patients with Overactive Bladder

The FDA has approved Myrbetriq (mirabegron) extended-release tablets, from Astellas, for the treatment of Overactive Bladder with symptoms of urge urinary incontinence, urgency and urinary frequency. The recommended starting dose for Myrbetriq is 25 mg once daily with or without food. Myrbetriq 25 mg is effective within eight weeks; based on individual efficacy and tolerability, the dose may be increased ...

FDA approves Verigene GP Blood Culture Nucleic Acid Test (Nanosphere) for identifying Bacterial Infections

The FDA has allowed marketing of the Verigene GP Blood Culture Nucleic Acid Test (BC-GP), from Nanosphere. This is the first nucleic acid test that can identify 12 different bacterial types known to cause bloodstream infections. The test allows for simultaneous identification of the bacteria and three associated resistance genes in just a few hours after the first sign of ...

Positive results from Phase IV study of MuGard (Access Pharma) for oral Mucositis

Results from the ongoing Phase IV clinical trial of mouth rinse treatment Mu-Gard, from Access Pharma, for oral Mucositis show that patients undergoing chemoradiation therapy for head and neck cancer and using Mu-Gard experienced a statistically significant reduction in mouth and throat soreness, a statistically significant delay to onset of oral Mucositis as measured in days or cumulative radiation, and ...

Positive results in Phase III study of VPRIV (Shire) for Gaucher-related bone disease

New data shows VPRIV (velaglucerase alfa for injection), from Shire, significantly improved selected markers of Gaucher-related bone disease in patients. A head-to-head Phase III study (HGT-GCB-039) of VPRIV and Cerezyme, and follow-on extension trial (HGT-GCB-044) of VPRIV, demonstrate a statistically significant improvement in lumbar spine (LS) bone mineral density in Gaucher patients starting at nine months of treatment with VPRIV, ...

FDA approves Belviq (Eisai/Arena Pharma) for Obesity

The FDA has approved Belviq (lorcaserin HCl), from Eisai and Arena Pharmaceuticals, as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adult patients with an initial body mass index of 30 kg/m2 or greater (Obese), or 27 kg/m2 or greater in the presence of at least one weight related comorbid condition. However the ...

NICE recommends Zytiga (Janssen Cilag) for metastatic Prostate Cancer

The National Institute for Health and Clinical Excellence (NICE) has published final guidance endorsing Zytiga (abiraterone acetate) from Janssen Cilag as an NHS treatment option for patients in England and Wales with metastatic castration resistant Prostate Cancer (mCRPC), if their disease has progressed despite having received a docetaxel-containing chemotherapy regimen....

AEZS 130 (Aeterna Zentaris) safe and effective in Growth Hormone Deficiency

Final Phase III results for its oral ghrelin agonist, AEZS 130 (macimorelin), from Aeterna Zentaris, show that the drug is safe and effective in diagnosing adult Growth Hormone Deficiency (AGHD). This multicenter open label study was originally designed as a cross-over trial of AEZS 130 vs growth hormone-releasing hormone (GHRH)+L-Arginine (ARG) in AGHD patients and in controls, matched for body ...

FDA give premarket approval for the Prostate Health Index (Beckman Coulter) to test for Prostate Cancer

The FDA has given Premarket Approval (PMA) for the Prostate Health Index (PHI), from Beckman Coulter. The PHI test is a non-invasive blood test that is 2.5-times more specific in detecting Prostate Cancer than PSA (prostate-specific antigen) in patients with PSA values in the 4-10 ng/mL range. Typically, physicians recommend that men with a PSA in that range consider a ...

MDV 3100 (Astellas) for Prostate Cancer submitted to EMA for marketing authorisation

Astellas has submitted a European marketing authorisation application to the EMA for MDV 3100 (enzalutamide) for the treatment of men with metastatic castration-resistant Prostate Cancer who have been previously treated with docetaxel-based chemotherapy. The submission follows positive results from the pivotal Phase III AFFIRM study, which confirmed that enzalutamide demonstrated a statistically significant improvement (p<0.0001) in overall survival with a ...

Obesity drug Lorqess (Eisai) shows positive trial results

A new study on the effects of Lorqess (lorcaserin), from Eisai, for the treatment of Obesity shows positive results. The study, titled BLOOM-DM, evaluated 604 obese and overweight participants with Type 2 Diabetes in a double-blind placebo-controlled randomized trial over a one-year treatment period. Although all participants received systematic lifestyle change counseling, those on the medication lost 4.5 – 5.0% ...

Positive results for Exjade (Novartis) in patients with Iron Overload

A new clinical study of Exjade (deferasirox), from Novartis, as a treatment for patients with Myelodysplastic Syndrome (MDS) a blood-related malignancy that involves the ineffective production of blood cells, shows beneficial iron reduction. The majority of patients with MDS require red blood cell transfusions for their anemia, but this leaves them at risk for iron overload. The results of this ...

Trial finds that Brilinta / Brilique (AstraZeneca) is cost effective for Acute Coronary Syndrome patients

Full data results of the PLATO health economics substudy, which have been published online in the European Heart Journal, demonstrate that even at a higher drug cost and incremental cost per Acute Coronary Syndrome (ACS) patient, Brilinta / Brilique (ticagrelor), from AstraZeneca, numerically lowered non-drug healthcare costs versus generic clopidogrel and is cost-effective. The analysis used in the health economics ...

CHMP recommends subcutaneous Velcade (Janssen) for Multiple Myeloma

The CHMP has granted a positive opinion recommending approval of subcutaneous administration of Velcade (bortezomib), from J&J Janssen Cilag, for patients with Multiple Myeloma. Subcutaneous bortezomib has fewer side effects and offers greater convenience for patients, with similar efficacy compared to intravenous bortezomib...

I-Stent (Glaukos Corporation) is FDA approved for Cataract Surgery

The iStent Trabecular Micro-Bypass Stent System, Model GTS100R/L, from Glaukos Corporation, was approved by the FDA on 26 June 2012. This is the first device approved for use in combination with cataract surgery to reduce pressure inside the eye (intraocular pressure) in adult patients with mild or moderate open-angle glaucoma and a cataract who are currently being treated with medication ...

CHMP recommends EU approval of Zyclara (Meda) for Actinic Keratoses

The CHMP has adopted a positive opinion regarding marketing authorization of Zyclara (imiquimod), from Meda, for the treatment of Actinic Keratoses (AK) on large skin areas. Zyclara shares the same active ingredient as Aldara and while both are approved by the FDA for the treatment of AK, there are key differences: Zyclara is indicated for daily use on an accelerated ...

FDA approves Gammagard Liquid 10% (Baxter) for Multifocal Motor Neuropathy

The FDA has approved Gammagard Liquid 10% [Immune Globulin Infusion (Human)] as a treatment for Mmultifocal Motor Neuropathy (MMN). This is the first immunoglobulin treatment approved for MMN patients in the United States. It was approved for use with MMN patients in Europe in 2011. MMN is associated with a progressive, asymmetric limb weakness mostly affecting the upper limbs, which ...

FDA issues Complete Response Letter for Eliquis (BMS/Pfizer) in Stroke Prevention

The FDA has issued a Complete Response Letter regarding the New Drug Application for Eliquis (apixaban) from BMS/Pfizer for the Prevention of Stroke and Systemic Embolism in patients with nonvalvular atrial fibrillation. The FDA requests additional information on data management and verification from the ARISTOTLE trial. BMS and Pfizer will work closely with the FDA on the appropriate next steps ...

VEN 309 (Vetrus Biosciences) fails Phase III for treatment of Haemorrhoids

Ventrus Biosciences, Inc. has reported that its Phase III, randomized, double-blind, placebo-controlled clinical trial of iferanserin (VEN 309) in patients with Haemorrhoidal Disease did not meet its endpoints.The Company will analyze the Phase III data further but believes that its efforts will be better allocated toward the planned completion of its VEN 307 (diltiazem cream) development program in anal fissures ...

Study shows positive results with dabrafenib (Glaxo Smith Kline) in Melanoma patients

A new study compared dabrafenib, from Glaxo Smith Kline, with the most commonly used existing treatment, dacarbazine (DTIC), in 250 patients suffering from spreading or inoperable BRAF-positive Melanoma. Half of the patients demonstrated a partial (47%) or complete response (3%) to the treatment in an independent review. By comparison, just 6% of patients treated with DTIC showed an improvement. Progression-free ...

CHMP recommends EU approval of Revestive (Nycomed) for treating Short Bowel Syndrome

The CHMP has recommended granting marketing authorisation for Revestive (teduglutide), from Nycomed, as a once-daily treatment for adult patients with Short Bowel Syndrome (SBS). The marketing authorisation application was submitted in March 2011. The CHMP opinion was based upon data from STEPS, the pivotal Phase III study in patients with SBS, who required parenteral nutrition; 43-patients were randomised to a ...

CHMP recommends Afinitor (Novartis) for (HR+) HER2/neu-negative advanced Breast Cancer

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for Afinitor (everolimus) tablets, from Novartis, in combination with exemestane, for the treatment of hormone receptor-positive (HR+), HER2/neu-negative (HER2-) advanced Breast Cancer, in postmenopausal women without symptomatic visceral disease after recurrence or progression following a non-steroidal aromatase inhibitor.The CHMP opinion ...

CHMP recommends Seebri Breezhaler (Novartis) for COPD

Novartis announced that the Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Seebri Breezhaler (glycopyrronium/NVA237) 44 mcg delivered dose (50 mcg glycopyrronium per capsule), as a once-daily inhaled maintenance bronchodilator treatment to relieve symptoms in adult patients with Chronic Obstructive Pulmonary Disease (COPD). Seebri Breezhaler is a long-acting muscarinic antagonist (LAMA), a type of ...

CHMP recommends Zinforo(AstraZeneca) for cSSTI or CAP infections

The Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion, recommending the approval of Zinforo (ceftaroline fosamil) (Teflaro in USA) from AstraZeneca, a new intravenous cephalosporin antibiotic for the treatment of adult patients with complicated Skin and Soft Tissue Infections (cSSTI) or Community Acquired Pneumonia (CAP).The CHMP reviewed data from the Phase III clinical trial programmes ...

CHMP refuses to recommend approval to Uplyso(Pfizer)for Gaucher Disease

The Committee for Medicinal Products for Human Use (CHMP) will not recommend approval to Uplyso (taliglucerase alfa) from Protalix/Pfizer for long-term enzyme replacement therapy for adults with Type 1 Gaucher disease because the drug works in the same way as Vpriv (velaglucerase alfa) from Shire and as Vpriv is an orphan drug it has 10 years exclusivity...

Cranberry juice and Urinary Tract Infections study

A new study from Jeffrey Blumberg at Tufts University evaluated the cranberry’s role in promoting urinary tract health through compounds known as proanthocyanidins (PACs). The study confirmed the presence of unmetabolized PACs in the urinary tract after consumption, adding some evidence to ex-vivo research that suggests potential benefits of the compounds found in cranberry juice. In addition, a pilot study ...

EMA accepts application for elvitegravir(Gilead Sciences) for HIV-1 treatment

The European Medicines Agency (EMA) has accepted the marketing authorisation application (MAA) for elvitegravir, an integrase inhibitor for the treatment of HIV-1 infection in treatment-experienced patients,from Gilead Sciences. The filing for elvitegravir was supported by 96-week data from a pivotal Phase III study (Study 145) in which the product (150mg or 85mg) dosed once daily was shown to be non-inferior ...

FDA Advisory Committee recommends Kyprolis(Onyx) for Multiple Myeloma

Onyx Pharmaceuticals announced that the FDA Oncologic Drugs Advisory Committee determined by a vote of 11-0 (with 1 abstention) that, in patients with relapsed and refractory Multiple Myeloma who have received at least two prior lines of therapy that included a proteasome inhibitor and an immunomodulatory agent, the benefit-risk assessment is favorable for the use of Kyprolis (proposed brand name ...