News

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, ...

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 ...

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 ...

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 ...

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 ...

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, ...

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 ...

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 ...

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 ...

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 ...

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 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) ...

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 ...

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 ...

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 ...

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....

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. ...

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 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.

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; ...

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 ...

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 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, ...

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 ...

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. ...

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 ...

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 ...

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 ...

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 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 ...

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 ...

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, ...

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 ...

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 ...

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, ...

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 ...

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. ...

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 ...

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 ...

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 ...

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 ...

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.

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 ...

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 ...

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 ...

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 ...

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 ...

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 ...

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 ...

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 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 ...

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 ...

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 ...

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 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, ...

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 ...

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 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 ...

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 ...

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....

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 ...

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...

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 ...

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). ...

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 ...

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 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 ...

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 ...

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....

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, ...

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....

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 ...

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 ...

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 ...

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....

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 ...

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 ...

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 ...

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....

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 ...

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 ...

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 ...

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 ...

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 ...

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 ...

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 ...

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....

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 ...

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 ...

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 ...

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 ...

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 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 ...

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 ...

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% ...

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 ...

FDA refuses to recommend semuloparin (Sanofi) for prevention of VTE

The FDA's Oncologic Drugs Advisory Committee voted 14 to 1 not to recommend approval of semuloparin, from Sanofi, for the prevention of Venous Thromboembolism (VTE) in patients receiving chemotherapy for metastatic Lung or Pancreatic Cancer. The committee also rejected its use in patients with advanced solid tumours with a VTE risk score greater than or equal to three. The submission ...

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 ...

FDA issues Complete Response Letter for tafamidis (Pfizer) for TTR-FAP

The FDA has issued a Complete Response Letter for the transthyretin familial amyloid polyneuropathy drug, tafamidis from Pfizer. The FDA has requested the completion of a second efficacy study to establish substantial evidence of effectiveness prior to an approval. Tafamidis was approved in the EU as an orphan drug with the name Vyndaqel....

Phase III study of Edarbyclor (Takeda) shows positive results for Hypertension

Results of a 12-week, head-to-head, Phase III study found systolic blood pressure (SBP) reductions of Edarbyclor (azilsartan medoxomil and chlorthalidone), from Takeda, were statistically superior to those of the fixed-dose combination of olmesartan medoxomil-hydrochlorothiazide in patients with Hypertension. Results after 12 weeks of treatment showed that the fixed-dose combination of azilsartan medoxomil and chlorthalidone 40/25 mg reduced clinic SBP by ...

Semuloparin (Sanofi) may need more data for FDA approval for prophylaxis of VTE

Semuloparin, a low molecular weight heparin from Sanofi ,is filed at the FDA for the prophylaxis of venous thromboembolism in patients receiving chemotherapy for locally advanced or metastatic pancreatic or lung cancer or for locally advanced or metastatic solid tumors. FDA regulators have commented that the application does not have enough data to support its approval for that use. The ...

Abediterol (Almirall/Forest) superior to indacaterol in Phase IIa trial for COPD

In the Phase IIa, single-dose, study change from baseline in trough FEV1 following a single dose administration of a range of abediterol from Almirall/Forest Labs. doses below 10µg once daily, showed a statistically significant improvement versus placebo (p<0.001 for all abediterol doses) and, also, versus indacaterol 150µg (p<0.001 for abediterol doses of 2.5, 5 and 10µg. Abediterol once-daily in fixed ...

Mallinckrodt to co market Sumavel Dose Pro for Migraine in US

Zogenix Inc. have appointed Mallinckrodt to co market Sumavel Dose Pro in the US. The 95-person Zogenix sales force in the US targeting neurologists, headache specialists and other physicians will be joined by a team of Mallinckrodt sales representatives who market pain drugs to primary care doctors....

Trametinib and dabrafenib(GSK) success in BREAK 3 and METRIC studies for Melanoma

GSK announced at the Annual Meeting of the American Society of Clinical Oncology in Chicago positive results for investigational BRAF and MEK inhibitors dabrafenib and trametinib.The BREAK 3 study of dabrafenib (BRAF inhibitor) and the METRIC study of trametinib (MEK inhibitor) demonstrated a statistically significant benefit in the length of time patients with BRAF V600 mutation positive advanced or Metastatic ...

CHMP recommends EU approval of Eklira (Almirall) for COPD

The EMA's CHMP has issued a positive opinion for the regulatory approval of Eklira (aclidinium), from Almirall, in all EU member states as a maintenance bronchodilator treatment to relieve symptoms in adult patients with Chronic Obstructive Pulmonary Disease (COPD). As part of its assessment, CHMP reviewed efficacy and safety data of aclidinium BID from more than 2,500 patients. The clinical ...

FDA Advisory Committee votes on tafamidis (Pfizer) for TTR-FAP

The FDA Peripheral and Central Nervous System Drugs Advisory Committee voted on the clinical data package for tafamidis meglumine submitted by Pfizer. Tafamidis is a novel, investigational, oral therapy for the treatment of Transthyretin Familial Amyloid Polyneuropathy (TTR-FAP) in adult patients with symptomatic polyneuropathy to delay neurologic impairment. The Advisory Committee did not find substantial evidence of efficacy on a ...

Dabrafenib (GSK) impressive in Metastatic Melanoma

A total of 184 patients with incurable solid tumours were enrolled (156 with Metastatic Melanoma) in a Phase 1 trial and given escalating doses of dabrafenib from Glaxo Smith Kline. The investigators established a recommended phase II dose (RP2D) of 150 mg twice daily.In the second stage, efficacy at the RP2D was studied in three groups of patients with BRAF-mutant ...

BI 1744-CL (Boehringer) shows positive results in Phase II COPD trial

A Phase II study shows that BI 1744-CL (olodaterol), from Boehringer, provides a significant increase in the lung function parameter FEV1 over a 24-hour period for patients with COPD. It found BI 1744-CL (5 microgram QD) provided significant improvement in lung function as measured by FEV1 AUC(0-12) versus twice-daily BI 1744-CL (2 microgram), while twice-daily dosing of BI 1744-CL (5 ...

Seebri Breezhaler(Novartis) success in GLOW 2 study for COPD

Novartis and Vectura reported one-year data from the pivotal, Phase III GLOW 2 study, confirming that the inhaled long acting muscarinic receptor antagonist, NVA237 (glycopyrronium bromide), is superior to placebo and has similar efficacy to open-label tiotropium in the treatment of patients with moderate-to-severe chronic obstructive pulmonary disease (COPD)....

Seebri Breezhaler (Novartis) success in GLOW-3 trial for COPD

The GLOW 3 study investigated the effects of Seebri Breezhaler (NVA237), (glycopyrronium bromide) 50 mcg once-daily from Novartis on exercise endurance in moderate-to-severe COPD patients. The study met its primary endpoint by showing a significant 21% improvement in exercise endurance versus placebo at the end of the study (i.e. day 21), with a significant 10% increase from day one (both ...

IMDx GBS (IntelligentMDx) test system for Group B Streptococcus receives CE mark

The IMDx GBS for Abbott m2000, from IntelligentMDx, an automated, high-throughput, qualitative in vitro diagnostic test designed for the rapid detection of Group B Streptococcus (GBS) for use in screening pregnant women and those in labor who may be infected with the pathogen, has received CE mark approval. The system utilizes real time PCR, operates on the Abbott m2000 system ...

FDA Advisory Comittee recommends Lorqess (Arena/Eisai)for weight loss

The FDA Endocrinologic and Metabolic Drugs Advisory Committee has recommended approval for Lorqess(lorcaserin) as a prescription weight-loss medicine in an 18-4 vote with one abstention. The Committee considered that the available data demonstrated the potential benefits of weight loss with lorcaserin outweigh its possible risks of valvular heart disease, adverse cardiovascular events or malignancies when used long-term in a population ...

NICE to recommend Botox (Allergan) for Migraine

NICE,the health technology appraisal institute for England and Wales, will now recommend Botox (botulinum toxin type A) injections from Allergan, as a preventative treatment for Chronic Migraine, in its final draft guidance. NICE was undecided about the drug and one area of concern was that the data supporting Botox were confounded by a large placebo effect. Allergan have provided more ...

Pressure Right (Pressure Point) device effective in reducing postoperative Nausea

A clinical study has shown the acupressure Pressure Right system, from Pressure Point, can enhance the efficacy of an antiemetic drug combination in reducing the incidence of postoperative Nausea and Vomiting among high-risk patients after major surgery. Pressure Right is a single-use, disposable device that is applied to patients’ wrists before induction of anesthesia. It operates by exerting pressure on ...

Janssen files Xarelto at FDA for Venous Thromboembolism and ACS

Janssen Research & Development, a Johnson & Johnson subsidiary, has filed at the FDA for approval of Xarelto (rivaroxaban) as a treatment for Deep Vein Thrombosis and Pulmonary Embolism, and as a preventative treatment for recurring Venous Thromboembolism. Deep Vein Thrombosis is a blood clot in large veins, usually in the legs. Those blood clots sometimes dislodge and travel to ...

EU approves Sancuso(ProStraken) for Nausea treatment

ProStrakan, a subsidiary of Kyowa Hakko Kirin, has received EC approval for Sancuso (granisteron transdermal patch0 in Europe. Sancuso is indicated for the prevention of nausea and vomiting associated with moderately or highly emetogenic chemotherapy, for a planned duration of three to five consecutive days, where oral anti-emetic administration is complicated by factors making swallowing difficult....

Phase III Study of QVA 149 (Novartis) for COPD meets primary endpoint and clarifies timing of US filings

New data on ILLUMINATE, a head-to-head Phase III study of QVA 149 (indacaterol plus glycopyrronium bromide), from Novartis, compared to Seretide(fluticasone plus salmeterol), shows the drug has met its primary endpoint in patients with moderate to severe Chronic Obstructive Pulmonary Disease. The ILLUMINATE study of more than 500 patients demonstrated that superior lung function (measured by FEV1 AUC0-12h with a ...

Review shows Botox (Allergan) offers modest benefit for chronic Migraine and daily headaches

A review of previous studies of Botox (onabotulinumtoxin A), from Allergan, finds a small to modest benefit for patients with chronic Migraine headaches and chronic daily headaches, although Botox injections were not associated with greater benefit than placebo for preventing episodic Migraine or chronic tension-type headaches. Pooled analyses of the data suggested that Botox was associated with fewer headaches per ...

Aliskiren (Novartis)availability terms agreed with FDA

Novartis announced that the Tekturna labels have been updated in the USA, following the FDA review of the preliminary findings from the ALTITUDE study.The label change includes a contraindication against combined use of aliskiren-based products with angiotensin converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs) in patients with diabetes. The FDA has also requested the inclusion of a warning ...

FDA approves i-Lipo (Chromogenex) for Fat Reduction therapy

The FDA has cleared the i-Lipo low-level laser diode device, from Chromogenex, to market for circumferential reduction or Fat Reduction. The clearance is based on results from a double-blind, placebo-controlled, randomized study of 34 volunteers in which over 70% of participants experienced significant waist reduction. Of the 34 participants, 19 were randomly selected for the treatment group and 15 for ...

IQWiG finds limited effect of Vyndaqel (Pfizer)in TTR-FAP

The German Institute for Quality and Efficiency in Health Care (IQWiG) has assessed Vyndaqel (tafamidis)from Pfizer at the request of the Federal Joint Committee. Only one of the two relevant studies (Fx-005) provided reliable data - and only for patients with a particular genetic defect (Val30Met). The second study (Fx1A-201) in adults with different genetic defects was not controlled, i.e. ...

First three Phase III studies positive for QVA 149 (Novartis)in COPD

The first three Novartis QVA149 (indacaterol 110 mcg/glycopyrronium bromide 50 mcg) Phase III studies in the treatment of chronic obstructive pulmonary disease (COPD) all met their primary endpoints. The SHINE, BRIGHT and ENLIGHTEN studies, which are key components of the IGNITE program, demonstrate the potential of QVA149 in the treatment of COPD.The results of SHINE, with an enrollment of more ...

Relovair (GSK/Theravance)programme is now complete for COPD and Asthma

Glaxo Smith Kline and Theravance, Inc. have announced that the registration programme for Relovair (fluticasone furoate plus vilanterol) is now complete. In addition, results from two studies for the once-daily Relovair (fluticasone furoate "FF"/vilanterol "VI" (FF/VI)) in patients with chronic obstructive pulmonary disease (COPD) and results from a study to evaluate the efficacy and safety of FF and FP (fluticasone ...

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....

Positive results for Xarelto (Bayer/Janssen) in PE and VTE

The results of the Phase III EINSTEIN-PE 4,833-patient study have been presented at the American College of Cardiology meeting in Chicago which show that Xarelto (rivaroxaban) from Bayer/Janssen was as effective and safe as the current dual drug approach of subcutaneous Lovenox (enoxaparin), followed by warfarin, in treating patients with acute symptomatic pulmonary embolism (PE) and preventing them from developing ...

FDA approves LINX Reflux Management System (Torax Medical Inc.) for GERD

The FDA on 22 March 2012 approved the LINX Reflux Management System from Torax Medical Inc., for people diagnosed with Gastroesophageal Reflux Disease (GERD) who continue to have chronic symptoms, despite the use of maximum medical therapy for the treatment of reflux.The LINX Reflux Management System is a sterile, single-use, surgically placed device used to treat the symptoms associated with ...

PA 32540 (Pozen) effective against Gastric Ulcers in Phase III study

Top-line results from Study 303, a Phase III trial tracking the safety of PA 32540, from Pozen Inc.,, in patients at risk for aspirin-associated Gastric Ulcers, shows that adverse events were consistent with those expected in this population of patients requiring cardio-aspirin therapy and with the known safety profile of the drug's components. PA 32540 is a combination tablet of ...

Positive results for Phase III study of Eklira/Bretairis (Almirall) for COPD

Full results of ATTAIN, a six month pivotal study of the efficacy and safety of Eklira/Bretairis (inhaled aclidinium), from Almirall, in patients with moderate to severe Chronic Obstructive Pulmonary Disease have been published in the European Respiratory Journal. Significant improvement from baseline was observed with aclidinium 200 microg and 400 microg versus placebo for trough FEV1 (99 and 128 mL; ...

Arcapta Neohaler (Novartis) is launched in USA for COPD

Novartis has launched its once-daily long-acting beta2 agonist Arcapta Neohaler (indacaterol inhalation powder) in the USA following its approval for chronic obstructive pulmonary disease by the FDA in July 2011. Indacaterol is already available in more than 30 countries following its first approval in the EU in November 2009 as Onbrez Breezhaler. The drug is approved in a total of ...

ALLEGRO trial of laquinimod reported in NEJM

Teva/Active Biotech have announced the publication of results from the laquinimod Phase III ALLEGRO study in the March 15 issue of The New England Journal of Medicine. Data from the two-year study showed that oral once-daily laquinimod reduced inflammatory disease activity as measured by clinical relapses and Magnetic Resonance Imaging (MRI), slowed disability progression and decreased brain tissue loss, while ...

Purocin protein technology (AvidBiotics) offers rapid response to E.coli infection

A new study shows that AvidBiotics' antibacterial Purocin protein technology can be used to create a highly targeted bactericidal protein against the life-threatening foodborne E. coli O104 strain by making use of rapidly acquired, published, draft genomic sequence data. This strategy offers a rapid-response platform with the potential to create targeted agents for use against emerging bacterial pathogens within days-to-weeks ...

FDA approves first generic Lexapro for Depression and Anxiety Disorder

The FDA has approved the first generic version of Lexapro (escitalopram tablets) to treat Depression and generalised Anxiety Disorder in adults. The generic is produced by Teva Pharmaceutical Industries/IVAX Pharmaceuticals who will be marketing generic escitalopram in 5 milligram, 10 mg, and 20 mg strengths. Teva has been granted a 180-day period of generic drug exclusivity, which means that FDA ...

Phase II study underway of Shok-Pak (Inflammagen Therapeutics) for patients with Shock

A 200-patient Phase II pilot study has begun to examine the efficacy and safety of the Shok-Pak, from InflammaGen Therapeutics, as a potential treatment for critically ill patients suffering from Multiple Organ Dysfunction Syndrome (MODS), formally known as multiple organ failure. Conditions expected to qualify for the study include new-onset sepsis and septic shock, post-operative complications and new-onset gastrointestinal bleeding. ...

Pycnogenol (Horpagh Research) improves Menopausal transition

Pycnogenol extract from Horpagh Research Ltd, can ease Menopause and digestive problems according to a recent study. Seventy peri-menopausal randomly assigned women received either placebo or pine bark extract (100mg of Pycnogenol) daily for 8 weeks. The pine bark extract group reported a reduction in symptoms of Menopause including hot flushes, night sweats, mood swings, irregular periods,loss of libido and ...

Results of Study 102 for Quad (Gilead) for HIV

Phase III results were announced from the pivotal Study 102 demonstrating that Quad,from Gilead Sciences, a fixed-dose, single-tablet regimen made up of the investigational drugs elvitegravir and cobicistat combined with the two active ingredients in Truvada (emtricitabine and tenofovir), is non-inferior to Atripla (efavirenz/tenofovir/emtricitabine) after 48 weeks of therapy in treatment-naive adults. At the end of the trial, 88% of ...

FDA approves FreeStyle InsuLinx Blood Glucose Monitoring System (Abbott)

The FDA has issued clearance for the FreeStyle InsuLinx Blood Glucose Monitoring System, from Abbott. This machine is designed to translate blood glucose measurements and individual patient data into accurately calculated insulin dosing suggestions. It includes a touch-screen interface, automated logbook and several personalization features designed to improve the diabetes management experience for patients. This device is equipped with built-in ...

Tentative FDA approval for generic Viagra

The patent for Viagra (sildenafil) from Pfizer expires in March 2012. The FDA on 7 March 2012 has granted tentative approval to Mylan Pharma for a generic sildenafil citrate for Erectile Dysfunction....

Biotie/Lundbeck report results of Phase III studies for Selincro for Alcholol Dependence

Biotie announced that its partner H. Lundbeck A/S has presented results from the Phase III program of Selincro (nalmefene), an investigational compound for the treatment of Alcohol Dependence, at the 20th European Congress of Psychiatry (EPA) in Prague, Czech Republic. Data from the three placebo-controlled phase III studies (ESENSE 1, ESENSE 2 and SENSE) was discussed during the symposium. In ...

FDA Advisory Committee recommends aclidium bromide(Forest/Almirall) for COPD

Forest Laboratories, Inc. and Almirall, S.A. announced that the FDA Pulmonary-Allergy Drugs Advisory Committee voted 12 to 2 in favor of approving the New Drug Application (NDA) for aclidinium bromide, a new long-acting antimuscarinic for the maintenance treatment of COPD. The Committee was also asked to separately evaluate if the efficacy and safety of the 400 ug twice daily dose ...

Trial of Vessix V2 Denervation System (Vessix Vascular) underway for Hypertension patients

Patient treatments have begun in the multi-centre REDUCE-HTN renal denervation clinical study of the Vessix V2 Renal Denervation System, from Vessix Vascular, for patients with uncontrolled Hypertension. REDUCE-HTN is a non-randomized, prospective, single cohort, 64-patient study designed to validate the clinical performance of the Vessix V2 System for medication-resistant Hypertensive patients. Renal denervation is a new percutaneous catheter-based procedure that ...

FDA Advisory Committee recommends Qnexa(Vivus Inc.) for treatment of Obesity

The FDA Endocrinologic and Metabolic Drugs Advisory Committee has voted 20-2 that the benefits of Qnexa (phentermine/topiramate) from Vivus Inc.,outweigh the risks in the treatment of Obesity. The committee recommended that Vivus should conduct a post-marketing study with regards to the potential cardiovascular side effects of Qnexa. The company has also proposed a risk evaluation and mitigation strategy which includes ...

FDA Advisory Committee recommends Qnexa(Vivus Inc.) for treatment of Obesity

The FDA Endocrinologic and Metabolic Drugs Advisory Committee has voted 20-2 that the benefits of Qnexa (phentermine/topiramate) from Vivus Inc.,outweigh the risks in the treatment of Obesity. The committee recommended that Vivus should conduct a post-marketing study with regards to the potential cardiovascular side effects of Qnexa. The company has also proposed a risk evaluation and mitigation strategy which includes ...

CHMP recommends Sancuso (ProStraken) for Nausea

The CHMP has adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Sancuso 3.1 mg/24 h transdermal patch from ProStraken Limited which is intended for the prevention of Nausea and Vomiting associated with moderately or highly emetogenic Chemotherapy. The active substance of Sancuso is granisetron.The benefits with Sancuso as compared to an oral formulation ...

CHMP defines limits of aliskiren (Novartis) in Hypertension

Novartis announced that the CHMP has concluded the risk-benefit review of Rasilez (aliskiren) and combination products containing aliskiren and confirmed it remains positive in the European Union for the treatment of essential Hypertension. In addition, the CHMP has requested an update to the product information of Rasilez® (aliskiren) and combination products containing aliskiren available in the EU. The CHMP has ...

NICE rejects Botox (Allergan) for Migraine prevention

NICE,the National Institute for Health and Clinical Excellence has published draft guidance rejecting the use of Botox (botulinum toxin type A)from Allergan, to prevent headaches in adult patients experiencing chronic Migraines. The Institute's committee of experts has concluded that there is not enough evidence to recommend the drug, and so has asked that its manufacturer Allergan provide additional information in ...

FDA accepts new drug application from Pfizer for tafamidis for TTR-FAP

After a Refusal to File notification from the FDA for tafamidis from Pfizer, the FDA has now accepted the new drug application for Transthyretin Familial Amyloid Polyneuropathy (TTR-FAP) a rare, progressive fatal neurodegenerative disease, which affects about 8,000 patients worldwide.The drug is approved as Vyndaqel in the EU....

FDA approves wider indication for fibrin sealant Tisseel (Baxter)

The FDA has approved Tisseel [Fibrin Sealant] from Baxter to include general hemostasis in surgery when control of bleeding by standard surgical techniques is ineffective or impractical.TISSEEL mimics the final stages of the body’s own blood clotting cascade, creating a clot that adheres to the wound surface and helps achieve hemostasis....

NICE final guidance positive for Eliquis(BMS/Pfizer)in VTE

NICE, the health technology appraisal body for England and Wales, has published final guidance recommending Eliquis (apixaban) from BMS/Pfizer as an option for preventing venous thromboembolism after knee and hip surgery. Eliquis will compete against Pradaxa from Boehringer abd Xarelto from Bayer HealthCare in this indication. No decision was made as to cost benefit comparisons....

Combination treatment with Tekturna/Rasilez (Novartis) raises risk for patients with Hypertension

Following the closure of the Phase III ALTITUDE trial, researchers have published the first detailed figures showing the risk of using Tekturna/Rasilez, from Novartis, in combination with angiotensin converting enzyme (ACE) inhibitors or angiotensin receptor blocker (ARB) drugs. After reviewing 10 large trials, researchers found that patients taking Tekturna/Rasilez as well as an ACE inhibitor or ARB had about a ...

Tekturna (Novartis) fails ALTITUDE study in Diabetic Hypertensive patients with Renal Impairment

Tekturna/Rasilez (aliskiren) from Novartis has failed to show a benefit in target organ protection which has resulted in the early closure of the Phase III ALTITUDE study by reason of safety concerns. The 8,606-patient trial was assessing the effects of adding aliskiren to standard antihypertensive treatment in patients with Type 2 Diabetes and RenalImpairment. Researchers found a higher rate of ...

Pfizer will not proceed with Lyrica for Restless Legs Syndrome

Pfizer will not proceed with regulatory approval for Lyrica (pregabalin), its GABA analogue, for Restless Legs Syndrome despite reporting positive Phase III results for the drug in this patient group....

Onduarp (Boehringer) is EMA approved for Essential Hypertension

Onduarp(telmisartan plus amlodipine) from Boehringer has been approved by the EMA for patients whose blood pressure is not adequately controlled by amlodipine alone. Onduarp can also be used in place of treatment with telmisartan and amlodipine in patients who are taking both medicines as separate tablets. The drug is FDA approved as Twynsta....

EU approves Edarbi (Takeda) for Hypertension

The European Commission has approved the once-daily angiotensin receptor blocker (ARB) Edarbi (azilsartan medoxomil) from Takeda for Essential Hypertension. The approval is based on seven Phase III trials involving nearly 6,000 patients where the drug showed its superiority to placebo and the highest approved doses of two commonly-prescribed ARBs, Benicar (olmesartan) from Daiichi Sankyo and Diovan (valsartan)from Novartis. The drug ...

Generic Caduet (Pfizer) launched in USA by Ranbaxy

Ranbaxy has launched in the USA, an authorised generic version of Caduet, the fixed-dose combination of atorvastatin-amlodipine besylate for Hypertension , as part of an agreement between Pfizer and Ranbaxy...

NICE recommends Eliquis (BMS/Pfizer) for Venous Thromboembolism Prevention

The National Institute for Clinical Excellence (NICE) has published final draft guidance recommending Eliquis (apixaban) from BMS/Pfizer as an option for the prevention of venous thromboembolism (VTE) in adults who have undergone planned total hip replacement or total knee replacement surgery/...

Rasitrio (Novartis) combination is EU approved for Hypertension

Rasitrio, the first triple combination of aliskiren, amlodipine and hydrochlorothiazide in a single pill from Novartis has received approval from the European Commission for the treatment of high blood pressure. The pivotal study supporting the application showed that Rasitrio produced statistically significant blood pressure reductions compared to dual combinations of each of its individual components, including aliskiren/amlodipine 300 mg/10 mg, ...

BD MAX Assay (Becton, Dickinson and Company) for MRSA detection is EU approved

The BD MAX MRSA Assay, from BD Diagnostics, a Becton Dickinson company, for rapidly and accurately identifing methicllin-resistant Staphylococcus aureus (MRSA) in patients has received CE mark approval in the EU. The BD MAX is a fully automated, bench-top molecular system designed to perform a broad range of molecular testing. This offers the flexibility and versatility to perform CE/in vitro ...

Sevikar HCT (Daiichi Sankyo) now available in the UK

Sevikar HCT (olmesartan medoxomil, amlodipine besylate plus hydrochlorothiazide) from Daiichi Sankyo Europe, the first three-in-one pill to treat Hypertension, has been launched in the UK. Currently around 2 million people in the UK need to take three or more pills daily to treat their hypertension. The drug is approved in the USA and available as Tribenzor....

CHMP continues to monitor safety profile of Pradaxa (Boehringer) for VTE

The EMA has issued a safety update on VTE treatment Pradaxa/Rendix, from Boehringer. It reports that the Agency is aware of recent media interest regarding fatal cases of bleeding in patients treated with the drug, but the CHMP is of the opinion that the recommended changes to the use of Pradaxa adequately manage the risk of bleeding. A worldwide total ...

Vyndaqel(Pfizer) is EU approved for TTR-FAP

Vyndaqel (tafamidis), an orphan medicine from Pfizer to treat transthyretin familial amyloidosis in adult patients with symptomatic polyneuropathy (TTR-FAP), a neurogenerative disease, is EU approved The approval is based on studies that demonstrated the novel specific transthyretin stabiliser showed efficacy in delaying peripheral neurologic impairment, plus 51%-81% less deterioration in neurologic function, plus large and small fibre function compared with ...

Eliquis versus enoxaparin in ADOPT study for VTE acutely ill patients

Phase 111 ADOPT (Apixaban Dosing to Optimize Protection from Thrombosis) trial evaluated Eliquis (apixaban) versus enoxaparin in acutely ill medical patients and showed that Eliquis did not meet the primary efficacy outcome of superiority to enoxaparin for the endpoint of venous thromboembolism (VTE) and VTE-related death at day 30. The apixaban arm had a 13 percent lower rate of events ...

Qnexa (Vivus Inc) Phase III results published in Obesity

Phase III data for Qnexa ((phentermine plus topiramate) from Vivus Inc., of the 56-week EQUIP study have been published in Obesity, the peer-reviewed journal of The Obesity Society. The trial evaluated the efficacy and safety of Qnexa in 1,267 severely obese (BMI >/= 35 kg/m2) patients in the USA. In addition to an average weight loss of 14.4% of initial ...

Lixiana development in VTE for USA and EU is discontinued

The US and EU development of Lixiana (edoxaban) from Daichi Sankyo is discontinued for the prevention of venous thromboembolic events after orthopaedic surgery although the drug is approved in Japan for that indication. Daiichi Sankyo will concentrate on the indication of stroke prevention in atrial fibrillation, for which results from the ongoing ENGAGE AF-TIMI 48 Phase III trial which compares ...

Vivus re-submiots Qnexa to the FDA for Obesity treatment

Vivus has resubmitted its new drug application to the FDA for its obesity treatment Qnexa (phentermine/topiramate), for a narrower patient population, which would include overweight men and women of non-childbearing potential. Vivus expects a final FDA decision in the second quarter of 2012. The question of potential birth defects associated with topiramate is being met with a new trial called ...

FDA approves CFC-free Combivent Respimat Inhaler for COPD

The FDA has announced the approval of Combivent Respimat (ipratropium bromide and albuterol sulfate) Inhalation Spray for patients with Chronic Obstructive Pulmonary Disease (COPD) on a regular aerosol bronchodilator who continue to have evidence of bronchospasm and who require a second bronchodilator. Combivent Respimat contains two different types of medicines that open airways in the lungs to help patients with ...

Astellas cancels its oral Factor Xa inhibitor ,darexaban

Astellas Pharma has decided to cancel its oral Factor Xa inhibitor, darexaban, after considering the competitive market for anticoagulants and the difficulty in finding a partner for the drug....

INTENSITY study of Onbrez Breezhaler and Spiriva in COPD reported in European Respiratory Journal

Results of the INTENSITY study ,being a comparison of Onbrez Breezhaler (indacaterol) from Novartis with Spiriva(tiotropium)from Boehringer/Pfizer were announced in November 2010. These results showed once-daily Onbrez Breezhaler was as effective as Spiriva in improving lung function in COPD patients. It also demonstrated that the indacaterol treatment provides "significantly greater clinical benefit in terms of reduced shortness of breath, lower ...

Combination Vfend plus Eraxis fails Phase III trial for Aspergillosis

A Phase III trial has failed to show a statistically significant benefit in combining antifungal medications, Vfend (voriconazole) plus Eraxis/Ecalta (anidulafungin) both drugs from Pfizer compared with using Vfend alone in treating invasive aspergillosis. Vfend now has generic competition in the USA...

Daxas shows positive data on "Frequent exacerbations" in COPD

New findings from a post-hoc pooled analysis of two one-year studies of more than 1,500 roflumilast-treated patients with severe COPD, chronic bronchitis and a history of exacerbations show that Daxas (roflumilast) from Nycomed ,helps to prevent exacerbations in COPD patients of the 'frequent exacerbator' phenotype. The 'frequent exacerbator' group show worse health status and faster disease progression than those who ...

GLOW 1 and GLOW 3 studies to support SeebriBreezhaler application.

The GLOW 1 and GLOW 3 studies show that investigational NVA237 (glycopyrronium bromide)from Novartis significantly increased patients' lung function compared to placebo with a fast onset of action at first dose, as well as improving exercise endurance. NVA237 is a new drug in the long-acting anti-muscarinic (LAMA) class which has recently been submitted for approval in the European Union under ...

CHMP recommends Edarbi/Ipreziv for Hypertension

The CHMP recommends Edarbi/Ipreziv (azilsartan medoxomil)from Takeda for essential hypertension.Azilsartan medoxomil blocks the angiotensin II type 1 receptors and inhibits the renin angiotensin aldosterone system, reducing blood pressure. The drug was approved by the FDA in February 2011.Takeda sees the drug as the successor to candesartan whose patent will expire in 2012....

CHMP recommends Onduarp for Hypertension

The CHMP recommends Onduarp (telmisartan plus amlodipine) from Boehringer for Essential Hypertension. The combination is FDA approved as Twynsta. The combination will be directed at difficult to treat BP patients and those having Type 2 Diabetes or who are obese or elderly....

FDA agrees with Orexigen the form of CV risk trial for Contrave

The FDA had requested a cardiovascular outcomes trial (CVOT) for Contrave (naltrexone HCl/bupropion)which Orexigen had rejected. After a meeting with the FDA the form of the CVOT has been agreed. The trial will take two years to complete and will be conducted with obese patients who have CV risk. Submission to the FDA can be made on the basis of ...

Eliquis launched in UK for VTE

BMS and Pfizer have launched their oral direct Factor Xa inhibitor, Eliquis (apixaban), in the UK for the prevention of venous thromboembolic events (VTE) in adult patients who have undergone elective total hip or knee replacement surgery....

FDA agrees form of CV risk trial for Contrave

The FDA had requested a cardiovascular outcomes trial (CVOT) for Contrave (naltrexone HCl/bupropion)which the company had rejected. After a meeting with the FDA the form of the CVOT has been agreed. The trial will take two years to complete and will be conducted with obese patients who have CV risk. Submission to the FDA can be made on the basis ...

Combination Oladaterol and Tiotropium enters Phase III for COPD

Boehringer Ingelheim has initiated its Phase III trial that will investigate Spiriva (tiotropium) in combination with a new compound, olodaterol, a novel once-daily long-acting beta-2 agonist ,for the treatment of chronic obstructive pulmonary disease. Spiriva (tiotropium), a long-acting muscarinic antagonist (LAMA) co-marketed with Pfizer, is the most prescribed COPD drug worldwide, while olodaterol is a novel once-daily long-acting beta-2 agonist ...

CHMP recommends triple combination Rasitrio for Hypertension

The CHMP has adopted a positive opinion for Rasitrio (aliskiren/amlodipine/HCTZ )from Novartis for the treatment of high blood pressure.Rasitrio has been recommended as replacement therapy in patients whose blood pressure is adequately controlled on a combination of its components given concurrently at the same dose level as in the combination.Adherence to treatment is often very challenging for patients requiring three ...

Qnexa to be re-filed at FDA for Obesity

Vivus will resubmit its application to the FDA for Qnexa (phentermine plus topiramate), by the end of October,which is about two months before top-line results are expected from the firm's retrospective observational study assessing fetal outcomes in the offspring of women exposed to topiramate(forming part of Qnexa) during the first trimester of pregnancy. Results of the study are expected by ...