News

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 ...

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 ...

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 ...

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. ...

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 ...

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, ...

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 ...

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 ...

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 ...

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) ...

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 ...

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 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 ...

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 ...

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 ...

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 ...

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 ...

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 ...

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 ...

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 ...

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 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 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 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 ...

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 ...

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 ...

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 ...

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 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 ...

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 ...

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.

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 ...

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 ...

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 ...

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 ...

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 ...

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 ...

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 ...

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 ...

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 ...

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 ...

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 ...

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 ...

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....

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 ...

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 ...

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 ...

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 ...

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 ...

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 ...

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. ...

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 ...

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 ...

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 ...

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 ...

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 ...

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 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 ...

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 ...

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 ...

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 ...

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 ...

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 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 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 ...

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 ...

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. ...

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 ...

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 ...

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 ...

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....

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 ...

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 ...

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 ...

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 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 ...

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 ...

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 ...

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 ...

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 ...

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 ...

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....

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). ...

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 ...

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 ...

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 ...

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 ...

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 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....

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....

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....

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 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 ...

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 ...

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 ...

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 ...

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 ...

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 ...

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 ...

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 ...

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 ...

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....

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 ...

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 ...

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 ...

Avandia/Nyracta (Glaxo SMith Kline) associated with Diabetic Macular Oedema in Type 2 Diabetes patients

Treatment with glucose-lowering thiazolidinedione drugs including Avandia/Nyracta, from Glaxo SMith Kline, in patients with Type 2 Diabetes appears to be associated with an increased risk of Diabetic Macular Oedema (DMO) at 1-year and 10-year follow-up evaluations. A retrospective study of 103,368 patients with Type 2 Diabetes and no DMO at baseline showed the incidence of DMO at 1 year was ...

J&J Janssen Cilag submits supplemental applications to extend use of Zytiga in Prostate Cancer

J&J Janssen Cilag International has submitted a type II variation to the EMA for Zytiga (abiraterone acetate). Simultaneously, Janssen Research & Development submitted a supplemental New Drug Application to the FDA. Both applications are intended to extend the use of Zytiga administered with prednisone for patients with metastatic castration resistant Prostate Cancer (mCRPC) who are asymptomatic or mildly symptomatic after ...

ORIGIN trial of Lantus(Sanofi)shows no CV effect or cancer risk

The landmark ORIGIN trial (Outcome Reduction with Initial Glargine Intervention)showed that Lantus (insulin glargine [rDNA] injection) from Sanofi had no statistically significant positive or negative impact on cardiovascular outcomes versus standard care during the study period. Results also showed that insulin glargine delayed progression from pre-diabetes to Type 2 Diabetes and there was no association between insulin glargine use and ...

Positive results from Phase III studies of TA 7284 (Janssen Pharmaceuticals) in patients with Type 2 Diabetes

Results from five Phase III clinical studies evaluating TA 7284 (canagliflozin), from Janssen Pharmaceuticals, in monotherapy and in add-on combination use showing that canagliflozin provided sustained glycemic improvements in adult patients with Type 2 Diabetes, and was generally well tolerated. In two of these studies comparing canagliflozin to current standard treatments, sitagliptin and glimepiride, canagliflozin provided significantly greater reductions in ...

Positive results for Optina (Ampio) in patients with Diabetic Macular Oedema

Ampio announces positive clinical trial results for the treatment of Diabetic Macular Oedema with orally administered Optina (danazol). The primary end point for efficacy was central subfield retinal thickness as measured by Optical Coherence Tomography (OCT). The study included 32 patients with moderate to severe Diabetic Macular Oedema (range 316-707 microns) that were treated orally with either placebo or one ...

Syncria (GlaxoSmithKline) shows mixed results in Phase III studies of Type 2 Diabetes patients

New results are reported for HARMONY 6, a 52-week randomised study comparing Syncria (albiglutide), from GlaxoSmithKline, to Lispro among patients with Type 2 Diabetes who were inadequately controlled on intermediate or long-acting insulin. In addition to previously reported results, the effect on HbA1c was maintained on continued treatment at 52 weeks (reduction from baseline of 1.01% vs 0.85%). In addition, ...

Insulin Degludec(Novo Nordisk) success in Nocturnal Hypoglycaemia

Ultra-long-acting insulin degludec, an investigational insulin being developed by Novo Nordisk, significantly reduced the rate of hypoglycaemia at night in adults with Type 2 Diabetes while obtaining equivalent improvement in glucose control compared with insulin glargine over a 52-week period. This phase IIIa study was presented today at the 72nd Scientific Sessions of the American Diabetes Association (ADA).The study also ...

Lyxumia(Sanofi) reduces HbA1c-glycated hemoglobin in Type 2 Diabetes

Lyxumia (lixisenatide) from Sanofi, a once-daily investigational GLP-1 agonist, in combination with basal insulin plus oral anti-diabetic agents (OADs), significantly reduced HbA1c - glycated hemoglobin - in people with Type 2 Diabetes who were either new to insulin therapy (as early as 12 weeks after initiation) or already treated with insulin (for an average of 3.1 years). Both GetGoal Duo ...

Positive data from EASIE trial for Lantus (Sanofi) in patients with early Type 2 Diabetes

Patients with early Type 2 Diabetes uncontrolled on metformin demonstrated superior HbA1c (glycated hemoglobin) reduction with Lantus (insulin glargine [rDNA origin] injection), from Sanofi, versus sitagliptin, according to data from the EASIE trial. Notably 50% more patients on Lantus achieved HbA1c less than 7% (68 vs. 42%) and less than 6.5% (40 vs. 17%) compared to sitagliptin, indicating improved glycemic ...

Positive results from two Phase III studies of Tradjenta (Boehringer/Eli Lilly) in Type 2 Diabetes patients

Results from two Phase III trials provide additional data evaluating the efficacy and safety of Tradjenta (linagliptin), from Boehringer/Eli Lilly, in adults with Type 2 Diabetes. Interim results of the first study showed that adding Tradjenta to a background of basal insulin – alone or in combination with metformin and/or pioglitazone – demonstrated a reduction in hemoglobin A1c of 0.65 ...

Positive resutls from Phase III study of Forxiga (AstraZenenca / BMS) for Type 2 Diabetes patients

Results from a Phase III clinical study of Forxiga (dapagliflozin), from AstraZeneca and BMS, demonstrate significant reductions in blood sugar levels (glycosylated hemoglobin levels, or HbA1c) compared with placebo at 24 weeks when either agent was added to existing sitagliptin therapy (with or without metformin) in adult patients with Type 2 Diabetes. The results were maintained over a 24-week extension ...

Positive results from trials of Bydureon (Amylin and Alkermes Inc) for Type 2 Diabetes

Results from an analysis of seven randomized clinical studies demonstrating that patients with Type 2 Diabetes treated with Bydureon (exenatide extended-release for injectable suspension), from Amylin and Alkermes Inc, experienced improvements in A1C, fasting glucose, weight and pulse pressure, regardless of baseline body weight. In the analysis more than 1,700 patients were stratified in quartiles by baseline body weight. Results ...

FDA approves Perjeta (Genentech/Roche) for combination use in metastatic Breast Cancer

Genentech/Roche announced that the FDA has approved Perjeta (pertuzumab). Perjeta is approved in combination with Herceptin (trastuzumab) and docetaxel chemotherapy for the treatment of people with HER2-positive metastatic Breast Cancer (mBC) who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease. This approval is based on data from a Phase III study which showed that people with previously ...

Medtronic files PMA for MiniMed 530G System for Diabetes monitoring and treatment

Medtronic has filed the final module of its Pre-Market Approval (PMA) application with the FDA for the MiniMed 530G system, an integrated insulin pump and continuous glucose monitor that automatically suspends insulin delivery if the sensor glucose value is equal to or below the low threshold value. Medtronic’s PMA submission includes data from the in-clinic ASPIRE study, which met its ...

Positive results for Phase III study of enzalutamide (Medivation) for Prostate Cancer treatment

Results from a Phase III clinical trial show that enzalutamide (formerly MDV 3100), from Medivation, prolongs lives of patients with Prostate Cancer. Patients in the AFFIRM trial who had stopped responding to chemotherapy evaluated 27 factors, including pain and energy levels and ability to work while taking MDV 3100. Results showed that around 43% of men taking the drug experienced ...

Exelixis reports results for XL 184 in Thyroid Cancer

Top line results were reported by Exelixis for XL 184 (cabozantinib) for the primary endpoint in the 330-patient Phase III EXAM study in patients with locally advanced or metastatic medullary Thyroid Cancer which showed a 7.2-month improvement in progression-free survival (PFS) with cabozantinib compared to placebo - 11.2 months of PFS versus four months. n terms of secondary endpoints, the ...

Sensipar (Amgen) fails endpoint in EVOLVE trial

The Phase III EVOLVE" (EValuation Of Cinacalcet HCl Therapy to Lower CardioVascular Events) trial results were announced by Amgen, which trial evaluated Sensipar/Mimpara (cinacalcet) for the reduction of the risk of mortality and cardiovascular (CV) events among 3,883 patients with secondary hyperparathyroidism (HPT) and chronic kidney disease (CKD) receiving dialysis. The primary endpoint of the study was time to the ...

Positive Phase III data for T-DM1 (Genentech/Roche) Breast Cancer patients

The Phase III EMILIA study of T-DM1 (trastuzumab emtansine), from Genentech / Roche, met its co-primary endpoint of a significant improvement in the time people with HER2-positive metastatic Breast Cancer lived without their disease getting worse. The study showed that the risk of disease worsening or death was reduced by 35 percent for people who received T-DM1 compared to those ...

Positive data from Phase III AURELIA trial of Avastin (Genentech/Roche) for Ovarian Cancer patients

A phase III study evaluating Avastin (bevacizumab), from Genentech/Roche, in combination with standard chemotherapy in women with Ovarian Cancer shows positive results. Data from the AURELIA study shows the risk of progression was reduced by 52 percent in women whose disease had worsened due to resistance to platinum-containing chemotherapy and who received Avastin plus chemotherapy compared with those who received ...

Positive Phase III data for Zytiga (J&J Janssen Cilag) plus prednisone for Prostate Cancer

Analysis of the Phase III study, COU-AA-302, demonstrated that patients with metastatic castration-resistant Prostate Cancer (mCRPC) treated with Zytiga (abiraterone acetate), from J&J Janssen Cilag, plus prednisone, showed a statistically significant improvement in radiographic progression-free survival (rPFS) and all secondary endpoints compared to patients treated with placebo plus prednisone. The median rPFS in the control arm was 8.3 months but ...

An NDA for TA 2784 (Jansssen Pharmaceuticals Inc.) is submitted to the FDA for Type 2 Diabetes

Janssen Pharmaceuticals Inc. (formerly Ortho McNeil) has submitted a New Drug Application (NDA) to the FDA seeking approval for the use of TA 2784 (canagliflozin) for the treatment of adult patients with Type 2 Diabetes. The filing is supported by a global Phase III clinical program which included nine multicentre, randomised clinical studies that enrolled approximately 10,300 patients, representing the ...

Carbozantinib (Exelixis) enters Phase III for metastatic castration resistant Prostate Cancer

COMET-1 trial is initiated for cabozantinib from Exelixis Inc., and is a double-blind, placebo-controlled Phase III study that will include up to 240 international sites. The trial is designed to enroll 960 patients with metastatic castration-resistant Prostate Cancer (mCRPC) who have previously been treated with docetaxel, and abiraterone acetate and/or MDV3100. All patients will have bone metastases and there is ...

BOLERO-2 study update for Afinitor (Novartis) in HR+ Breast Cancer presented at ASCO

An 18-month analysis from the Phase III BOLERO-2 study from Novartis confirms that Afinitor (everolimus) plus exemestane, an aromatase inhibitor, more than doubled the time postmenopausal women with hormone receptor-positive (HR+) advanced breast cancer lived without tumor growth (progression-free survival; PFS).The updated results show median PFS for everolimus plus exemestane was 7.8 months compared to 3.2 months with hormonal therapy ...

CHMP recommends EU approval of Jentadueto (Boehringer) for Type 2 Diabetes

The EMA's CHMP recommend approval of Jentadueto (linagliptin plus metformin), from Boehringer, alongside diet and exercise to improve glycaemic control in adults with Type 2 Diabetes. If approved by the EU the drug will provide a new, single-tablet treatment option for adults with Type 2 Diabetes who need to improve control of their blood glucose. The recommendation for approval was ...

Alogliptin (Takeda) filed at EMA for Type 2 Diabetes

The European Medicines Agency has accepted for review alogliptin,a selective dipeptidyl peptidase IV (DPP-4) inhibitor from Takeda for Type 2 Diabetes. The filing is based on trials involving more than 11,000 patients and several ongoing studies, including the EXAMINE trial which is evaluating cardiovascular endpoints following treatment with alogliptin. The FDA has isssued a Complete Response Letter in respect to ...

Early success for CDX 011 (Celldex) in Phase II Breast Cancer study

Preliminary results were announced from the randomized Phase IIb EMERGE study of CDX-011 (glembatumumab vedotin) antibody drug conjugate from Celldex Therapeutics, in patients with glycoprotein NMB (GPNMB) expressing, advanced, heavily pretreated Breast Cancer. Preliminary results suggest that CDX-011 induces impressive response rates compared to current, available therapies in patients with advanced, refractory breast cancers with high GPNMB expression.In this high ...

Enzalutamide is filed at FDA by Medivation for Prostate Cancer

Medivation has submitted a New Drug Application (NDA) to the FDA for enzalutamide (formerly MDV3100). The compound has been studied in patients with castration-resistant prostate cancer who have received docetaxel therapy.Enzalutamide is an oral, once-daily investigational agent that is an androgen receptor signaling inhibitor. Enzalutamide inhibits androgen receptor signaling in three distinct ways: it inhibits 1) testosterone binding to androgen ...

Dulaglutide(Eli Lilly) positive for hypertension effects

Dulaglutide, the long-acting glucagon-like peptide 1 (GLP-1) analog, from Eli Lilly which is being studied as a once-weekly treatment for Type 2 Diabetes, met its primary endpoint of non-inferiority for mean 24-hour systolic blood pressure (SBP, or pressure while the heart contracts) after 16 weeks. The results came from a Phase II study that compared two doses of dulaglutide to ...

FDA expands use of Levemir (Novo Nordisk) for Type 1 Diabetic children

The FDA has approved Levemir (insulin detemir [rDNA origin] injection), from Novo Nordisk, for expanded use in children ages two to five years with Type 1 Diabetes. With the expansion of its pediatric indication, Levemir is now available for Type 1 Diabetes patients from age two through adulthood and adult patients with Type 2 Diabetes. The decision was based on ...

Nucynta (J&J Janssen) provides pain management for Patients with Diabetic Peripheral Neuropathy

A Phase III study suggests Nucynta ER (tapentadol) tablets, from J&J Janssen, were significantly more effective than placebo in providing pain management among adults with chronic moderate to severe, painful Diabetic Peripheral Neuropathy (DPN). This trial had three phases: an open-label phase, in which the individually optimized tapentadol ER dose (100-250 mg two times per day) was determined for each ...

NICE draft guidance now approves Zytiga (J&J Janssen Cilag) for Prostate Cancer

NICE has issued new draft guidance recommending the use by the NHS of Zytiga (abiraterone acetate), from J&J Janssen Cilag, in patients with Prostate Cancer. After additional information about the drug was submitted to NICE by the company, the treatment will now be made routinely available for patients on the NHS. NICE had previously rejected the drug because it did ...

Successful Phase III study for Signifor for Acromegaly

Results of the largest Phase III study of Acromegaly patients, PASPORT-ACROMEGALY, show the novel therapy Signifor ( pasireotide) long-acting release (LAR) from Novartis, was significantly more effective at inducing full biochemical control compared to the current standard medical therapy, Sandostatin LAR (octreotide/IM injection). These data were presented at the 2012 joint 15th International Congress of Endocrinology and 14th European Congress ...

BioChaperone(Adocia) success in Phase II trial for Diabetic Foot Ulcers

Phase II results of BioChaperone demonstrated non-inferiority in a comparison with Johnson & Johnson/Healthpoint Biotherapeutic's Regranex gel 0.01% (becaplermin).Analysis of negative side effects, collected through the intent-to-treat population of 192 patients, did not identify any serious side effect related to the treatment. These safety results indicate that BioChaperone PDGF-BB is well tolerated and safe at the three doses tested for ...

Ophena is filed by Shionogi Inc at FDA for Vaginal Atrophy

Shionogi Inc. has submitted a new drug application to the FDA for Ophena (ospemifene),an oral selective oestrogen receptor modulator licensed from QuatRx Pharmaceuticals The FDA filing is for a 60mg tablet formulation for the treatment of vulvular and vaginal atrophy in post-menopausal women, including moderate to severe symptoms of dyspareunia (painful intercourse) and/or vaginal dryness and physiological changes such as ...

Study shows Avandamet (Glaxo Smith Kline) superior to metformin alone for Type 2 Diabetes

A new study shows Avandamet (rosiglitazone and metformin), from Glaxo Smith Kline, was more effective in treating youth with recent-onset Type 2 Diabetes than metformin alone. Adding an intensive lifestyle intervention to metformin provided no more benefit than metformin therapy alone. The study also found that metformin therapy alone was not an effective treatment for many of these youth. In ...

FDA responds to Takeda's NDAs for Type 2 Diabetes therapies Nesina and combination Nesina and Actos

The FDA has provided a complete response letter to Takeda regarding its NDAs for Type 2 Diabetes drugs Nesina (alogliptin) and Actos (fixed-dose combination alogliptin and pioglitazone). This combination therapy is now being sold in Japan under the brand name Liovel. Takeda is set to request a meeting with the FDA to determine the appropriate next steps. Recently, Takeda provided ...

EU approves Signifor (Novartis) for Cushing's Disease

Novartis announced that the European Commission has approved Signifor (pasireotide) for the treatment of adult patients with Cushing's Disease for whom surgery is not an option or for whom surgery has failed. Signifor is the first medicine to be approved in the European Union (EU) targeting Cushing's Disease. The approval is based on data from the largest randomized Phase III ...

Lower rates of hypoglycaemia with Insulin Degludec compared to Insulin Glargine

Two phase III studies included in total 1,635 participants investigated insulin degludec from Novo Nordisk compared to insulin glargine in a basal-bolus regimen in people with Type 1 and Type 2 Diabetes. Both studies were ‘treat-to-target’ studies, meaning patient insulin doses were adjusted systematically to allow them to achieve a targeted fasting glucose level. As a result, patients, successfully achieved ...

FDA approve Contour Next EZ (Bayer HealthCare) for blood glucose monitoring

The FDA has cleared the Contour Next EZ blood glucose monitoring system, from Bayer HealthCare, for use by diabetic patients in the US. The Contour Next EZ includes an easy-to-use meter and test strip sensors with innovative technology for advanced accuracy. Bayer's new BGM system is being introduced on a market-by-market basis and is currently available in other countries as ...

CHMP recommends Forxiga (AstraZeneca/BMS) for Type 2 Diabetes

AstraZeneca and Bristol-Myers Squibb Company announced that the CHMP of the European Medicines Agency has recommended the approval of Forxiga (dapagliflozin) tablets for the treatment of Type 2 Diabetes, as an adjunct to diet and exercise, in combination with other glucose-lowering medicinal products including insulin, and as a monotherapy in metformin intolerant patients....

NICE rejects Avastin/Xeloda (Roche) combination for Breast Cancer

NICE does not recommend the use of Avastin (bevacizumab) from Roche in combination with Xeloda (capecitabine) for first line treatment of metastatic Breast Cancer. It has previously refused to recommend Avastin in combination with a taxane for first line treatment. An improvement in overall survival and better quality of life was not clear....

Valeant Pharma to market Halaven for Breast Cancer in Eastern Europe

Valeant Pharma (Swiss division) will distribute Halaven (eribulin) from Eisai in Bulgaria, Estonia, Latvia, Lithuania, Poland, Romania, Hungary and Slovenia for the treatment of patients with metastatic Breast Cancer whose disease has progressed after at least two chemotherapeutic regimens. Halaven is approved in the USA and EU....

BIND-014 first nanomedicine to enter clinical studies

BIND-014 is the first targeted and programmed nanomedicine to enter human clinical studies. The Phase 1 study has been electronically published in Science Translational Medicine. BIND-014 is a programmable nanomedicine that combines a targeting ligand and a therapeutic nanoparticle. BIND-014 contains docetaxel, a proven cancer drug which is approved in major cancer indications including breast, prostate and lung, encapsulated in ...

Entinostat (Syndax/GSK) enetrs Phase I/II trial for Breast Cancer

Syndax Pharmaceuticals, Inc., a clinical-stage epigenetics oncology company, announced that investigators at The University of Texas MD Anderson Cancer Center Department of Breast Medical Oncology have initiated a phase 1/II study combining entinostat, a benzamide histone deacetylase inhibitor, from Syndax Pharma with lapatinib ditosylate (Tykerb) in patients with locally recurrent or distant relapsed metastatic Breast Cancer previously treated with trastuzumab ...

FDA updates Victoza (Novo Nordisk) label to show superiority to Januvia

The FDA has approved to update the product label for Victoza (liraglutide [rDNA] injection) from Novo Nordisk to include data showing superior blood sugar control and weight reduction when compared to Januvia (sitagliptin0from Merck Inc,....

GSK announces progress in HARMONY Syncria programme for Type 2 Diabetes

Topline results have been received from seven of the eight ‘HARMONY’ Phase III studies investigating the use of Syncria (albiglutide) from GSK in Type 2 Diabetes. Albiglutide is an investigational once weekly glucagon-like peptide-1 (GLP-1) agonist. In HARMONY 6, the second of the phase III ‘HARMONY’ studies to complete, albiglutide was compared to preprandial insulin, each administered on top of ...

CDP7851/AMG 785 (UCB/Amgen) enters Phase III for Osteoporosis

UCB and Amgen have announced the start of their sclerostin antibody (CDP7851/AMG 785) Phase III clinical trial program for the treatment of Post Menopausal Osteoporosis. The Phase III program includes a multicenter, international, randomized, double-blind, placebo-controlled, parallel-group, two-year study in more than 5,000 postmenopausal women with osteoporosis. The primary endpoint will evaluate the incidence of new vertebral fractures at 12 ...

NICE rejects Halaven (Eisai) for Breast Cancer

NICE, the health technology appraisal institute for England and Wales has rejected Halaven (eribulin) from Eisai for locally advanced or metastatic breast cancer in patients whose disease has progressed after at least two chemotherapeutic regimens. The rejection comes after a failed appeal from Eisai against the final draft recommendations. Evidence indicated that Halaven might help some patients live "a little ...

Januvia approved in UK for use in renally impaired diabetic patients

The Medicines and Healthcare products Regulatory Agency (MHRA) has approved Januvia (sitagliptin) from Merck Inc., in the UK for use in patients suffering from moderate to severe renal impairment. As a result, another treatment will be available for individuals with sub-optimum kidney function, who represent up to one third of all those with diabetes....

Farletuzumab (Morphotek) now in Phase III trial for Ovarian Cancer

Morphotek/Eisai has completed enrollment of the FAR-131 clinical trial. The study is a pivotal Phase III randomized trial of Farletuzumab in first-relapsed patients with platinum-sensitive ovarian cancer. Farletuzumab is a humanized monoclonal antibody that targets folate receptor alpha (FRA), which is expressed on the majority of non-mucinous epithelial ovarian cancers as well as a subset of other carcinomas....

IMPACT study for Provenge (Dendreon) effect in Prostate Cancer questioned

Marie Huber in a paper in the Journal of the National Cancer Institute argues that Provenge (sipuleucel-T)from Dendreon extended survival because older men in the IMPACT study who did not receive Provenge died months sooner than similar patients in other studies possibly due to leukapheresis. She argues that the placebo they received was actually harmful making the Provenge effect appear ...

Genentech reports successful EMILIA study results for T-DMI for HER-2 Breast Cancer

Topline results of EMILIA, the first randomized Phase III study of T-DM1 (trastuzumab emtansine) are announced by Genentech. The study enrolled people with HER2-positive metastatic Breast Cancer (mBC) who had previously received treatment with Herceptin (trastuzumab) and a taxane chemotherapy. The study showed people who received trastuzumab emtansine lived significantly longer without their disease getting worse (progression-free survival, or PFS) ...

BOLERO-2 trail shows bonbe improvement with Afinitor/Aromasin combination in Breast Cancer

A review of BOLERO-2 Phase III trial in oestrogen receptor positive post menopausal women showed that the combination of Afinitor (everolimus) plus Aromasin (exemestane) significantly improved bone strength and reduced the chance of cancer spreading to the bone. The trial had earlier shown that this drug combination significantly improved outcomes stopping tumour growth for nearly 11 months...

Results show Protelos (Servier) slows progression of Osteoarthritis

New results of a Phase III study show that Protelos (strontium ranelate), from Servier, show the drug has beneficial effects for Osteoarthritis as well as offering beneficial effects on pain, function, and mobility. In the study, 1,683 patients with knee Osteoarthritis received either Protelos 2g/day, 1g/day or placebo. The primary endpoint was the measurement of narrowing of the medial-tibio femoral ...

Mammaprint genomic test (Agendia) spares Breast Cancer patients chemotherapy with no adverse effect on survival

Testing a Breast Cancer tumour for its genomic signature using the Mammaprint assay, from Agendia, can help identify which patients will need adjuvant systemic therapy (additional chemotherapy) after surgery, and spare its use in those for whom it is not necessary. The researchers studied 427 patients with early Breast Cancer in a study called RASTER. By looking for a particular ...

Byetta (Amylin) is EU approved for use with basal insulin in Type 2 Diabetes patients

The European Commission has granted marketing authorization to Byetta (exenatide twice-daily) from Amylin/Eli Lilly as an adjunctive therapy to basal insulin, with or without metformin and/or Actos (pioglitazone), for the treatment of Type 2 Diabetes in adults who have not achieved adequate glycemic control with these agents. From 2013 exenatide products will be marketed exclusively by Amylin which may seek ...

Onglyza (BMS/AstraZeneca)alerts for hypersensitivity reactions

BMS and AstraZeneca have alerted physicians in both the EU and US to reports of serious hypersensitivity reactions to Onglyza (saxagliptin). Labelling changes have been made following reports, which include 56 cases of pancreatitis, 70 cases of angioedema and 11 cases of anaphylactic responses received spontaneously from worldwide sources. Reports on hypersensitivity included anaphylaxis, angioedema and exfoliative skin conditions. Saxagliptin ...

Positive update from Phase II trial of Optina (Ampio Pharma) for Diabetic Macular Oedema

An interim review of the first 50% of patients enrolled in a Phase II trial of Optina (danzol), from Ampio Pharma, for Diabetic Macular Oedema has been completed. A preliminary assessment of the primary end point (as determined by optical coherence tomography) indicates a beneficial and consistent effect with the ultra-low dose of Optina at 4 and 12 weeks of ...

FDA approves generic Bonviva (Roche)

The FDA has approved the first generic versions of Boniva (ibandronic acid), from Roche, a once-monthly product to treat or prevent Osteoporosis in women after menopause. The manufacturers that have gained FDA approval for generic 150 milligram tablets are Apotex, Orchid Healthcare, and Mylan. The once-monthly Bonviva branded 150 mg tablet was originally approved by the FDA in March 2005....

Protelos(Servier) indication for Osteoporosis to be updated by EMA

The EMA still views Protelos/Osseor (strontium ranelate) from Servier Labs as an "important treatment" for women with Osteoporosis and its benefit: risk profile remains favourable, but it is no longer to be recommended for certain patients,and warnings on serious skin reaction will be updated. Prescribers should no longer prescribe the treatment to patients with current venous thromboembolism (VTE) or a ...

Phase III study of Zytiga (Janssen) for Prostate Cancer unblinded

A Phase III study of Zytiga (abiraterone acetate), from Janssen, plus prednisone for the treatment of asymptomatic or mildly symptomatic patients with metastatic castration-resistant Prostate Cancer (CRPC) has been unblinded. Study COU-AA-302 is an international, placebo controlled study that included 1,088 patients randomised to receive Zytiga (1,000 milligrams) once daily plus prednisone 5 mg twice daily or placebo plus prednisone ...

FDA approves Inform HER2 Dual ISH DNA Probe cocktail assay (Ventana MS) as Breast Cancer assay

The FDA has approved the Inform HER2 Dual ISH DNA Probe cocktail assay (HER2 Dual ISH), from Ventana Medical Systems, for use on the Ventana BenchMark ULTRA automated slide staining platform. It was originally approved by the FDA in June 2011 for use with the BenchMark XT instrument. The Inform HER2 Dual ISH assay is intended for use in the ...

FDA approves lower dose Angeliq (Bayer HealthCare) for Menopause treatment

The FDA has approved a lower dose formulation of Angeliq (drospirenone and estradiol), from Bayer HealthCare, to treat moderate to severe vasomotor symptoms due to Menopause in women who have a uterus. The new formulation contains 0.25 mg drospirenone (drsp)/0.5 mg estradiol (E2) and will be available in the US by prescription shortly. The previously approved prescription formulation contains 0.5 ...

Positive outcome to EU decentralized approval of Iluvien (Almeria Sciences) for DME

There has been a positive outcome of the Decentralized Procedure (DCP) for Iluvien (fluocinolone acetonide), from Alimera Sciences, in Europe for treatment of Diabetic Macular Oedema (DME). The announcement follows the issuance of the Final Assessment Report from the Reference Member State (RMS), the Medicines and Healthcare products Regulatory Agency of the United Kingdom (MHRA), and the agreement of all ...

EU approves Esmya (PregLem) for moderate to severe symptoms of Uterine Fibroids

The European Commission has granted marketing authorization to Esmya (ulipristal acetate), from PregLem, as pre-operative treatment of moderate to severe symptoms of Uterine Fibroids. This decision follows positive opinion from the CHMP of the European Medicines Agency on 16 December 2011 and is applicable for all Member States in the European Union. The approval is based on the assessment of ...

Phase II study of TAK 875 (Takeda) shows improved glycemic control in patients with Type 2 Diabetes

Phase II data for TAK 875, from Takeda, demonstrated that at doses ranging from 6.25 to 200 mg a day, the drug met its primary endpoint of statistically significantly lowering HbA1c (blood glucose) levels over a 12-week period versus placebo in patients with Type 2 Diabetes. This was achieved without significant increase in the incidence of hypoglycemia. The study evaluated ...

Actelion acquires rights to Xiaflex/Xiapex from Auxilium Pharma

Actelion will acquire from Auxilium Pharma exclusive rights to commercialise Xiaflex (collagenase Clostridium histolyticum) as a treatment for two rare progressive collagen deposit conditions, Dupuytren’s contracture and Peyronie’s disease, in Canada, Australia, Brazil and Mexico.Xiaflex has already been approved in the US and the EU to treat Dupuytren’s contracture, a fibroproliferative disease in which abnormal collage deposits result in nodules ...

TH-302 (Threshold/Merck Serono) success in Phase IIb Pancreatic Cancer trial

TH-302 a hypoxia targetted drug from Threshold Pharma/Merck Serono has produced a significant 63% extension in progression-free survival in a Phase IIb study in Pancreatic Cancer. The pancreatic cancer study combined TH-302 with gemcitabine for first-line treatment of advanced disease, with a primary endpoint of progression-free survival (PFS). The primary efficacy analysis performed on 149 patients showed median PFS of ...

European Commission approves Caprelsa(AstraZeneca) for medullary Thyroid Cancer

The European Commission has granted marketing authorisation for Caprelsa (vandetanib) for the treatment of aggressive and symptomatic medullary Thyroid Cancer in patients with unresectable locally advanced or metastatic disease. Caprelsa is the first approved treatment for advanced medullary Thyroid Cancer in Europe. Caprelsa was granted orphan drug status and approved by the FDA in April 2011. Caprelsa is also approved ...

Phase II study of SKL 11197 (SK Biopharmaceuticals) for Diabetic Peripheral Neuropathy initiated in US

SK Biopharmaceuticals has initiated a Phase II trial for US patients suffering with Diabetic Peripheral Neuropathy using their investigational drug SKL11197. Unlike many other drugs currently marketed for the treatment of Neuropathic Pain that were originally developed for the treatment of epilepsy or depression, SKL11197 has been developed solely for the treatment of pain. SKL11197 has already been proven safe ...

FDA approves Korlym (Corcept Therapeutics) for Cushings Syndrome

The FDA has approved Korlym (mifepristone)(formerly Corlux) from Corcept Therapeutics to control high blood sugar levels (hyperglycemia) in adults with endogenous Cushing’s syndrome. This drug was approved for use in patients with endogenous Cushing’s syndrome who have Type 2 Diabetes or glucose intolerance and are not candidates for surgery or who have not responded to prior surgery. Korlym should never ...

FDA approves Bio-T-Gel (Teva) for Male Hypogonadism

The FDA) has approved Bio-T-Gel, which is licensed by BioSante to Teva Pharmaceuticals USA, Inc. Bio-T-Gel is a testosterone gel for the treatment of male hypogonadism or low testosterone levels. Male hypogonadism is generally characterized by impotence, a lack of sex drive, muscle weakness and osteoporosis. The current U.S. market for male testosterone products is estimated at over $1.6 billion....

NICE rejects Tyverb (GSK) as first line treatment of Post Menopausal Breast Cancer

NICE finds that the overall survival benefit of Tyverb (lapatinib) from GSK, alongside aromatase inhibitors, as first line treatment for post menopausal breast cancer patients whose disease has spread is of small effect and uncertain and not cost effective....

NICE rejects Herceptin (Roche) as first line treatment for Post Menopausal Breast Cancer

NICE finds that the overall survival benefit of Herceptin (trastuzumab)from Roche/Genentech, alongside aromatase inhibitors as first line treatment for post menopausal breast cancer patients whose disease has spread is of small effect and uncertain and not cost effective....

Phase III Trial of MDV 3100 (Medivation/Astellas) in Prostate Cancer patients shows positive results

Researchers have presented positive results on all efficacy endpoints from the Phase III AFFIRM trial of the investigational drug MDV 3100, from Medivation and Astellas, in men with Prostate Cancer previously treated with chemotherapy. The results, presented at the 2012 Genitourinary Cancers Symposium, show that men taking MDV 3100 lived for a median of 18.4 months, compared with 13.6 months ...

FDA approves Jentadueta(Boehringer/Eli Lilly) for Type 2 Diabetes

Boehringer Ingelheim and Eli Lilly and Company announced the FDA has approved Jentadueto (linagliptin/metformin hydrochloride) tablets, a new tablet combining the dipeptidyl peptidase-4 (DPP-4) inhibitor, linagliptin, and metformin. Jentadueta provides a new, single-tablet treatment option, taken twice-daily, for patients who need to control their blood sugar. Linagliptin (5 mg, once-daily) is marketed in the U.S. as Tradjenta (linagliptin) tablets....

CHMP recommends Signifor (Novartis) for treatment of Cushing's Disease

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for Signifor (SOM230, pasireotide)from Novartis for the treatment of Cushing's Disease. There are currently no approved medicines in the European Union targeting Cushing's Disease, a debilitating endocrine disorder caused by excess cortisol in the body due to the presence of ...

FDA issues Complete Response Letter for dapagliflozin (AstraZeneca/BMS) for Type 2 Diabetes

The FDA has issued a Complete Response Letter regarding the New Drug Application for investigational compound dapagliflozin from BMS/AstraZeneca for the treatment of Type 2 Diabetes in adults. Dapagliflozin is a once a day, SGLT 2 inhibitor. The complete response letter requests additional clinical data to allow a better assessment of the benefit-risk profile for dapagliflozin. This includes clinical trial ...

Combining 2 anti-HER2 drugs may provide better preoperative breast cancer treatment

Adding Tyverb/Tykerb(lapatinib), from Glaxo Smith Kline, to Herceptin (trastuzumab) was more effective than single-drug treatment with either drug in eliminating microscopic signs of early-stage HER2-positive Breast Cancer at the time the tumors were surgically removed. The 455 patients in the NeoALTTO study were given anti-HER2 treatment with either intravenous trastuzumab, oral lapatinib or both for 6 weeks. Tumors were removed ...

GLP-1R Agonists lead to weight loss in overweight or obese patients

Giving overweight or obese patients the Glucagon-like peptide-1 (GLP-1) that suppresses appetite leads to clinically beneficial weight loss as well as reduced blood pressure and cholesterol levels. The GLP-1 agonists assessed were exenatide given twice daily, exenatide given once weekly (as a long acting release), and liraglutide given once daily. The study analysed the results of 25 randomised controlled trials ...

Tradjenta (Boehringer) shows no added benefit in assessment for Type 2 Diabetes

In a review, the German Institute for Quality and Efficiency in Health Care (the institute that investigates the benefits and harms of medical interventions for patients) has found that the added benefit of the Type 2 Diabetes drug Tradjenta (linagliptin), from Boehringer, is not proven since the drug manufacturer deviated from appropriate comparator therapy specified by the Federal Joint Committee ...

Zytiga (J&J Janssen Cilag) offers benefits for Prostate Cancer patients who are not eligible for docetaxel therapy

In an early benefit assessment, the German Institute for Quality and Efficiency in Health Care (IQWiG) has noted a considerable added benefit of Zytiga (abiraterone acetate), from J&J Janssen Cilag, in patients with metastatic hormone-refractory Prostate Cancer who are not eligible for further treatment with docetaxel. Zytiga has been approved since September 2011 for men with metastatic Prostate Cancer that ...

European decentralised approval concluded for Steovess (Takeda) for Osteoporosis

Takeda Pharmaceuticals International GmbH announced that the European decentralised procedure was positively concluded for Steovess (formerly known as EX101), a once-a-week 70mg buffered effervescent alendronate for the treatment of Post-menopausal Osteoporosis. The Company submitted its application for marketing authorization in multiple countries through the DCP on 17 September 2010, with the United Kingdom (MHRA) serving as its Reference Member State ...

Olaparib (AstraZeneca)will not proceed to Phase III in Ovarian Cancer

AstraZenenca announced that Olaparib will not progress into Phase III development for the maintenance treatment of serious Ovarian Cancer. The decision to discontinue olaparib’s development in Ovarian Cancer was made following a review of an interim analysis of a Phase II study (study 19) which indicated that the previously reported progression free survival benefit is unlikely to translate into an ...

Phase III study of Menerba (Bionovo Inc)commences for Menopausal Hot Flashes

The first patient will begin dosing in the Phase III clinical trial evaluating the safety and efficacy of two doses of the oestrogen receptor beta agonist Menerba (MF101), from Bionovo Inc, among a cohort of postmenopausal women for the treatment of Menopausal Hot Flashes. A total of 50 sites will enroll 1,200 postmenopausal women between the ages of 40 and ...

CHMP recommends Esmya (PregLem) for pre-operative treatment of Uterine Fibroids

The CHMP has issued a positive recommendation for Esmya (ulipristal acetate) from PregLem ( a subsidiary of Gedeon Richter), for pre-operative treatment of symptoms of uterine fibroids in adult women. Esmya is a pre-operative treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age. Treatment is limited to three months because there are no data ...

FDA Approves 's Cervista HTA System (Hologic) for Cervical Cancer screening

The FDA has approved the Cervista HTA (high throughput automation) system, from Hologic Inc, for use with the company's previously approved Cervista human papillomavirus (HPV) HR test. The Cervista HPV HR test utilizes Hologic's Invader technology to detect 14 high risk types of HPV that are associated with Cervical Cancer and precancerous lesions. The Cervista HTA system automates the DNA ...

Herceptin (Roche) may equalise DFS for obese and normal weight Breast Cancer patients

Obese patients with HER2-positive Breast Cancer have larger tumours, increased lymph node involvement and, when not treated with Herceptin (trastuzumab), from Roche, poorer long-term outcomes than normal-weight patients. The study, known as N9831, included 3,017 patients and was the first to explore the relationship between body mass and the patient's response to treatment and disease-free survival (DFS). Patients were assigned ...

Omnitarg (Genentech/Roche ) success in CLEOPATRA trial in untreated HER-2 positive Breast Cancer

The CLEOPATRA study enrolled 808 patients with previously untreated HER2-positive metastatic breast cancer. Patients receiving Omnitarg (pertuzumab), from Genentech/Roche, on top of the current standard treatment combination of trastuzumab (Herceptin) and docetaxel showed a median progression-free survival of 18.5 months, compared with 12.4 months for patients receiving Herceptin and docetaxel alone (hazard ratio 0.62, 95% CI 0.51-0.75, p<0.0001). This increase ...

Why women with Breast Cancer quit aromatase therapy

Just over a third of postmenopausal women who are treated for estrogen-sensitive Breast Cancer using drugs such as Arimidex (anastrozole), from AstraZeneca, and Aromasin (exemestane), from Pfizer, that help prevent the disease from recurring, quit early (before an average of 4.1 years) because of the medications’ side effects, which are more severe and widespread than previously known. Clinicians consistently underestimate ...

Zometa (Novartis) shows clear benefits for premenopausal ER-Positive Breast Cancer patients

A new study of Zometa (zoledronic acid), from Novartis, for Breast Cancer reveals that Zometa and endocrine treatment reduce death risk by 36%, but also that the risk of recurrence drops 28% for patients with early-stage, premenopausal ER-positive Breast Cancer. Data from the ABCSG-12 trial, reported at the 2011 CTRC-AACR San Antonio Breast Cancer Symposium, confirmed and extended data reported ...

Aromasin (Pfizer) found to lower 'good' cholesterol levels in Breast Cancer patients

Aromasin (exemestane), from Pfizer, steadily lowered levels of "good" cholesterol in women taking the agent as part of a Breast Cancer prevention study, say researchers at Georgetown Lombardi Comprehensive Cancer Center who presented results at the CTRC-AACR San Antonio Breast Cancer Symposium. They suggest that the effect this agent has on blood lipids may prove to be significant for women ...

Zometa (Novartis) with endocrine therapy improves survival in post menopausal Breast Cancer patients

Adding Zometa (zoledronic acid), from Novartis, to adjuvant endocrine therapy increased bone mineral density and reduced the risk for disease recurrence among postmenopausal women with early hormone receptor-positive Breast Cancer, according to new data from the ZO-FAST trial. Researchers randomly assigned 1,065 patients who were about to commence letrozole, an aromatase inhibitor, to receive immediate Zometa every six months or ...

Tyverb (GSK) disappoints in HER2 positive Breast Cancer

GSK presented results from the TEACH study to the 2011 CRTC-AACR San Antonio Breast Cancer Symposium. TEACH is a randomised, double-blind, placebo-controlled Phase III trial to evaluate the effects of Tyverb/Tykerb ( lapatinib )monotherapy when given to women who were diagnosed with HER2 positive breast cancer. The primary objective of the study was to compare disease-free survival (DFS) between women ...

Addition of Avastin (Genentech) to conventional therapy improves survival in HER2-positive Breast Cancer

An independent review committee has revealed that the addition of Avastin (bevacizumab), from Genentech/Roche, to trastuzumab and docetaxel significantly improved progression-free survival in HER2-positive Breast Cancer, despite findings from an investigator assessment that the improvement was present but statistically non-significant. Results from AVEREL, a 426-patient Phase III trial designed to evaluate the drug combination as first-line therapy for HER2-positive, locally ...

Exemestane plus Afinitor (Novartis) increased progression-free survival for Breast Cancer patients

Afinitor (everolimus), from Novartis, in combination with exemestane has shown promise for the treatment of Breast Cancer, according to a new analysis of the BOLERO-2, Phase III clinical trial, presented at the 2011 CTRC-AACR San Antonio Breast Cancer Symposium. Results revealed a median progression-free interval of 3.2 months for 239 patients treated with exemestane plus placebo. Among the 485 patients ...

Omnitarg (Genentech/Roche) success in Phase II Breast Cancer trial in combination with Herceptin and chemotherapy

In the Phase II NEOSPHERE study, published Online First in The Lancet Oncology, the addition of monoclonal antibody Omnitarg (pertuzumab) from Genentech/Roche, to standard therapy (trastuzumab (Herceptin) plus the chemotherapy drug docetaxel) for women with HER2-positive Breast Cancer improved the rate of complete tumor disappearance by over half after just four cycles, i.e. 12 weeks of treatment compared with the ...

Meta Analysis supports no increased risk of cancer by use of Lantus (Sanofi-Aventis)

A new meta-analysis in relation to Lantus( insulin glargine) was presented at the World Diabetes Congress in Dubai, which added to "the wealth of evidence resulting from more than 80,000 patients enrolled in clinical trials and 38 million patient years of treatment exposure to Lantus (insulin glargine)". The figures are derived from databases as well as from clinical trials and ...

Insulin Degludec plus Insulin Aspart (Novo Nordisk) in Phase III Diabetes trials

Insulin degludec plus insulin aspart from Novo Nordisk, reduced rates of hypoglycaemia by 58% in people with Type 2 Diabetes compared to biphasic insulin aspart when dosed twice-daily. The study was released by Novo Nordisk at the International Diabetes Federation (IDF) 21st World Diabetes Congress. In the study, insulin degludec/insulin aspart reduced the overall occurrence of hypoglycaemia during the day ...

Lyxumia(Sanofi-Aventis) positive in GET-GOAL DUO study in Type 2 Diabetes

Lyxumia(lixisenatide) from Sanofi-Aventis, a GLP-1 agonist, in combination with Lantus (insulin glargine) achieved its primary efficacy endpoint of significantly reducing HbA1c, with a significant improvement in post-prandial glucose, in the GetGoal Duo 1 study in patients with Type 2 Diabetes. This randomized, double-blind, placebo-controlled study included a 12-week run-in period with insulin glargine initiated and titrated to reach a target ...

Onglyza (BMS/AstraZeneca) plus Insulin is EMA approved for Type 2 Diabetes

The European Medicines Agency (EMA) has approved Onglyza (saxagliptin)from BMS/AstraZeneca for use as a combination therapy with insulin (with or without metformin) to improve blood sugar (glycaemic) control in adult patients with Type 2 Diabetes. The approval was based on Phase IIIb 24-week data submitted to EMA which showed that Onglyza 5 mg added to insulin (with or without metformin) ...

Komboglyze (BMS/AstraZeneca) is EU approved as a combination for Type 2 Diabetes

The EMA has granted marketing authorisation for Komboglyze from BMS/AstraZeneca, which combines the DPP-4 inhibitor Onglyza (saxagliptin) with metformin in a once-a-day pill.The combo is to be used as an adjunct to diet and exercise to improve glycaemic control in adults with Type 2 Diabetes inadequately controlled on their maximally tolerated dose of metformin alone or those already being treated ...

Cobas HPV test (Roche) offers sensitive primary screening strategy for cervical cancer

A sub-analysis of the ATHENA study demonstrates that the Cobas HPV Test, from Roche, could be used for the primary screening of Cervical Cancer. The data, published recently in The Lancet Oncology also showed that identifying women with HPV 16 and/or 18, the two genotypes detected in approximately 70 per cent of Cervical Cancers, provided important predictive information to determine ...

Takeda re-files Nesina at the FDA for Type 2 Diabetes

Takeda has re-filed applications for Nesina (alogliptin) as a monotherapy and alogliptin plus pioglitazone at the FDA following a Complete Response Letter as the FDA requires a cardiovascular safety study to support the monotherapy application. A large-scale, placebo-controlled study called EXAMINE has enrolled around 5,400 patients and the resubmissions are supported by interim data from this study which compares alogliptin ...

CHMP recommends Nevanac(Alcon/Novartis) for Diabetic Macular Oedema following Cataract Surgery

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion on a new indication for Nevanac (nepafenac), from Alcon/Novartis, as follows: "Reduction in the risk of postoperative macular oedema associated with cataract surgery in diabetic patients". Cystoid macular edema (CME) can occur following routine, uncomplicated cataract surgery. Because macular oedema is ...

FDA approves BSD-2000 (BSD) for use with Cervical Cancer treatment

The FDA has given Humanitarian Device Exemption (HDE) marketing approval for the BSD-2000 Hyperthermia System, from BSD Medical Corporation, for use in conjunction with radiation therapy for the treatment of Cervical Cancer patients who normally would be treated with combined chemotherapy and radiation but are ineligible for chemotherapy due to patient related factors. The HDE approval authorizes the commercial sale ...

FDA delays review of Nesina (Takeda) for Type 2 Diabetes treatment

The FDA has announced that its review of investigational Type 2 Diabetes therapy Nesina (alogliptin), from Takeda, along with the fixed-dose combination therapy alogliptin/pioglitazone, will be delayed. The new Prescription Drug User Fee Act (PDUFA) action date has been set for April 25, 2012. The FDA originally assigned a PDUFA action date of January 25, 2012. Nesina is a highly ...

Potential role for dapagliflozin (BMS/AstraZeneca)in Cardioprotection

A pre-specified meta-analysis of cardiovascular safety data from 14 Phase IIb/III trials in adult patients treated with dapagliflozin (BMS/AstraZeneca) with Type 2 Diabetes, was conducted in accordance with FDA guidelines for the assessment of cardiovascular safety in new antidiabetic treatments. The results were presented at the American Heart Association (AHA) Scientific Sessions in Orlando, Florida and showed that the compound ...

FDA withdraws approval of Avastin (Genentech) for Breast Cancer patients

The FDA has revoked the agency’s accelerated approval of the Breast Cancer indication for Avastin (bevacizumab), from Genentech. According to the FDA, Avastin has not shown benefit for delaying the growth of tumours in patients with metastatic Breast Cancer and thus cannot justify its costs and serious and potentially life-threatening risks. Nor is there evidence that use of Avastin helps ...

Syncria (*GSK) is inferior to Victoza in Type 2 Diabetes trial

Syncria(albiglutide)a once weekly investigational glucagon-like peptide-1 agonist from GlaxoSmithKline failed to show non-inferiority to once daily Victoza (liraglutide) from Novo Nordisk in patients with Type 2 Diabetes in the Phase III HARMONY 7 trial. This is the first of eight Phase III studies of albiglutide to complete in Type 2 Diabetes. Results showed a reduction in HbA1c of 0.78% for ...

Janacti (Merck Inc.) withdrawn in Europe for Type 2 Diabetes

Merck has withdrawn its application for centralised marketing authorisation in Europe for Janacti(sitagliptin and pioglitazone), for the 100/30 mg and 100/45 mg fixed-dose combination tablets, based on a review of the regulatory and commercial prospects for the fixed-dose combination product....

CHMP recommends Caprelsa (AstraZeneca) for Thyroid Cancer

The CHMP has recommended vandetanib, as Caprelsa from AstraZeneca for the treatment of advanced, aggressive and symptomatic medullary thyroid cancer in patients with unresectable locally advanced or metastatic disease, a rare form thyroid cancer. Previously the drug was known as Zactima. The drug has been approved by the FDA and the decision was based on the ZETA study....

FDA requires two new trials for Iluvien(Alimera Sciences) for Diabetic Macular Oedema

The FDA now requires an additional two trials for Iluvien (fluocinolone acetonide) from Alimera Sciences before granting an approval for Diabetic Macular Oedema associated with Diabetic Retinopathy as the company has not provided sufficient data. This may mean a two year delay to American approval. Alimera Sciences plans to file in the UK this month....

SMC 021 fails Phase III trial for Post Menopausal Osteoporosis

SMC 021, an oral salmon calctonin from Novartis, failed to meet main fracture reduction endpoints in Study 2303 a study of Post Menopausal Osteoporosis and to demonstrate a significant difference between treatment groups at three years for the primary endpoint of reducing new vertebral fractures. Similarly no statistical significant response was observed on key secondary endpoints such as new non-vertebral ...

EU approvbes Plenadren (DuoCort Pharma) for Adrenal Insufficiency

The European Commission has granted marketing authorisation for dual-release hydrocortisone replacement therapy Plenadren (hydrocortisone, modified-release) from DuoCort Pharma as a once-daily oral treatment for adults with adrenal insufficiency – the first new therapy for the condition in 50 years. DuoCort Pharma is being acquired by Viro Pharma....

Successful Phase III trial for Natpara (NPS Pharma) for Hypoparathyroidism

Positive top-line results were announced in November 2011 from the Phase III REPLACE study of NPSP 558,(Natpara) from NPS Pharma, the bioengineered replica of human parathyroid hormone, or rhPTH 1-84, in adult hypoparathyroidism patients. Fifty three per cent of the Natpara-treated patients in the intent-to-treat analysis achieved the primary endpoint of a 50% or greater reduction in oral calcium supplementation ...

Studies show Cervarix (GlaxoSmithKline) protects against serious precursor to invasive Cervical Cancer

Two studies show the human papillomavirus (HPV) vaccine Cervarix (papillomarvirus vaccine), from GlaxoSmithKline, offers excellent protection against the more serious immediate precursor to invasive Cervical Cancer (ICC), particularly when given to young adolescent girls before they become sexually active. They also show that the vaccine partially protects against four other cancer-causing HPV types not targeted by the formulation, that together ...

Amylin acquires world rights to Byetta and Bydureon for Type 2 Diabetes from Eli Lilly

Amylin and Eli Lilly have agreed to revise their collaboration concerning the Type 2 Diabetes therapies ,Byetta (exenatide injection) and Bydureon (exenatide extended release, being the weekly version),as a result of Eli Lilly entering a collaboration with Boehringer for competitor Tradjenta (linagliptin).Amylin will acquire all the rights to Byetta and Bydureon and pay royalties to Eli Lilly. Court proceedings will ...

Radiotherapy combined with androgen deprivation therapy improves survival in Prostate Cancer patients

Men with locally advanced Prostate Cancer and who receive radiotherapy (RT) on top of their androgen deprivation therapy (ADT) using treatments such as leuprolide acetate have greater overall survival compared with men on ADT alone. This trial followed 1205 patients were randomly assigned to either ADT and RT or ADT alone. The addition of RT to ADT improved overall survival ...

Byetta (Amylin and Eli Lilly) for Type 2 Diabetes also has rapid and powerful anti-inflammatory action

Byetta (exenatide), a drug from Amylin and Eli Lilly, which is commonly prescribed to help patients with Type 2 Diabetes, also has a powerful and rapid anti-inflammatory effect according to a new study. This rapid, anti-inflammatory effect may lead to the inhibition of Atherosclerosis, the major cause of Heart Attacks, Strokes and Gangrene in Diabetics. The study involved 24 obese ...

Phase III trial of MDV 3100 (Medivation/Astellas) shows significant benefits for patients with advanced Prostate Cancer

An analysis of a Phase III trial of men with advanced Prostate Cancer treated using MDV 3100, from Medivation and Astellas, shows the AFFIRM trial has met its interim efficacy stopping criteria by demonstrating a statistically significant improvement in survival. Those on the drug outlived those on placebo by an average of 4.8 months, and the trial has been stopped ...

Lyxumia (Sanofi-Aventis) is filed at EMA for Type 2 Diabetes

Lyxumia ( lixisenatide )from Sanofi Aventis a GLP-1 agonistis filed at EMA as monotherapy and as add-on to other anti diabetes medications, including Lantus.The application is supported by the Get Goal series of nine trials....

Actos improves efficacy of radioiodine therapy in Metastatic Thyroid Cancer

A new study of the effectiveness of Actos(pioglitazone), from Takeda, given prior to radioiodine therapy in patients with Metastatic Thyroid Cancer suggests the drug can enhance the effectiveness of the radiotherapy when repeated. Usually, repeated radio-ablation therapy with iodine-131 to treat Metastatic Thyroid Cancer can be less effective than the initial treatment round due to de-differentiation of the cancer cells ...

Switching from tamoxifen to Aromasin improves Breast Cancer survival rate

Changing to Aromasin (exemestane), from Pfizer, after two to three years of tamoxifen treatment can cut women's risk of dying from Breast Cancer, according to new data. The study, led by Professor Judith Bliss, Director of the Institute of Cancer Research’s Clinical Trials & Statistics Unit, examines the effectiveness of switching to Aromasin after two to three years tamoxifen to ...

Femara offers significant advantages over tamoxifen for Breast Cancer patients

New results of a 12-year study suggest that treatment with Femara (letrozole), from Novartis, offers lower recurrence rates and significantly improved long-term survival time for women with hormone receptor-positive early Breast Cancer compared to tamoxifen therapy. According to the study's lead author, Meredith Regan from the Dana-Farber Cancer Institute in Boston, women given Femara monotherapy after surgery for five years ...

Byetta is FDA approved for use with Insulin Glargine in Type 2 Diabetes

The FDA has approved a new use for Byetta (exenatide) injection from Amylin/Eli Lilly. Byetta is now approved as an add-on therapy to insulin glargine, with or without metformin and/or a thiazolidinedione (TZD), in conjunction with diet and exercise for adults with Type 2 Diabetes who are not achieving adequate glycemic control on insulin glargine alone....

Subcutaneous Herceptin trial reveals benefits for Breast Cancer patients

Women with HER2-positive early Breast Cancer treated with a new, investigational subcutaneous (SC) injection of Herceptin (trastuzumab), from Roche, experienced comparable results to those given Herceptin as an intravenous (IV) infusion, according to new results from a Phase III study. According to results of the HannaH trial involving 596 women, the SC administration takes around 5 minutes to administer whereas ...

SiMoA PSA test found a reliable predictor of Prostate Cancer recurrence

A clinical evaluation of the SiMoA Prostate Specific Antigen (PSA) test, from Quanterix, shows that this digital immunoassay is a reliable predictor of five–year biochemical recurrence (BCR)–free survival following radical prostatectomy (RP) in patients with Prostate Cancer. To determine the ability of this test to predict five–year BCR–free survival following RP, researchers utilized frozen serum specimens from men who had ...

FDA warns that Leukemia drug Sprycel can lead to PAH

The FDA has issued a warning that treatment with Sprycel (dasatinib), from BMS, may increase the risk of a rare, but serious condition in which there is abnormally high blood pressure in the arteries of the lungs, called pulmonary arterial hypertension (PAH). With PAH, the heart must work harder to pump the blood into the lungs and the overworked heart ...

Zometa prevents bone loss side effects of Breast Cancer medication

The Osteoporosis drug Zometa (zoledronic acid), from Novartis, appears to protect against the bone damaging side effects of certain Breast Cancer medications, according to results in the journal Cancer. Many postmenopausal women with Breast Cancer are treated for several years with aromatase inhibitors, but as a side effect, these agents can cause bone loss and fractures. So a five-year study, ...

Afssaps refers Protelos to EMA for re-evaluation as a treatment for Post Menopausal Osteoporosis

The French regulatory agency Afssaps has decided not to suspend Protelos (strontium ranelate),the Post Menopausal Osteoporosis drug from Servier Labs. Afssaps has referred the drug to EMA and asked for a re-evaluation. There are safety concerns due to cases of venous thrombo-embolism in patients over 80 years of age (who have additional risk factors) and cases of DRESS (dry rash ...

FDA approves Juvisync combination for Type 2 Diabetes and elevated Cholesterol

The FDA has approved MK 0431C or Juvisync (sitagliptin and simvastatin), from Merck, the first single tablet for both Type 2 Diabetes and elevated Cholesterol. Sitagliptin and simvastatin are already approved medications to separately treat these conditions. To meet the different needs of individual patients and to ensure safe and effective use of Juvisync, tablets containing different doses of sitagliptin ...

Puma Biotechnology licenses neratinib for Breast Cancer from Pfizer

Pfizer has granted a worldwide licence of neratinib, its Phase-III oral tyrosine kinase inhibitor, to Puma Biotechnology. Neratinib is a novel treatment of Breast Cancer being an inhibitor of the ErbB1 (EGFR), ErbB2 (HER2) and ErbB4 (HER4) kinases....

FDA issues warnings on Avastin

The FDA has issued new warnings concerning Avastin (bevacizumab) from Genentech/Roche, in relation to ovarian failure, osteo-necrosis of the jaw and venous thromboembolism ,including bleeding. These warnings have been added to the US label. The FDA has also indicated thea it is likely to remove the breast cancer indication of the drug....

Early stage Breast Cancer benefit from Herceptin and chemotherapy

Treating women with early stage Breast Cancer using a combination of chemotherapy and the molecularly targeted drug Herceptin (trastuzumab), from Genentech, significantly increases survival in patients with a specific genetic mutation (HER-2) that results in very aggressive disease, according to a paper in the New England Journal of Medicine. The three-armed study compared the standard therapy of Adriamycin and Carboplatin ...

NICE rejects Jevtana for Prostate Cancer

NICE, the health technology appraisal institute for England and Wales, has issued draft guidance declining to recommend Jevtana (cabazitaxel) from Sanofi-Aventis for prostate cancer patients already treated with Taxotere ( docetaxel). Reasons given are the high cost of the new drug and concerns about adverse events. Sanofi is promoting Jevtana as a replacement for now generic Taxotere....

LB 03002 success in treatment of Growth Hormone Deficiency

Phase III results were announced of 24 months efficacy and safety in children with Growth Hormone Deficiency (GHD) for LB 03002, a once-a-week, sustained release recombinant human growth hormone (hGH) from Biopartners and LG Life Sciences (LGLS), at the annual meeting of the European Society for Paediatric Endocrinology. The study involved 167 paediatric patients with GHD. The data demonstrate that ...

BOLERO-2 study of Afinitor in ER+HER-2 advanced Breast Cancer is presented at EMCC congress

A pivotal Phase III study-BOLERO-2 examined the safety and efficacy of Afinitor (everolimus) from Novartis in combination with exemestane versus exemestane alone in postmenopausal women with ER+HER2- advanced breast cancer who recurred or progressed while on or following previous treatment with hormonal therapies, letrozole or anastrozole. BOLERO-2 results show Afinitor plus exemestane, a hormonal therapy, more than doubled the time ...

BOLERO-2 study of Afinitor in ER+HER-2 advanced Breast Cancer is presented at EMCC Congress

A pivotal Phase III study-BOLERO-2 examined the safety and efficacy of Afinitor (everolimus) from Novartis in combination with exemestane versus exemestane alone in postmenopausal women with ER+HER2- advanced breast cancer who recurred or progressed while on or following previous treatment with hormonal therapies, letrozole or anastrozole. BOLERO-2 results show Afinitor plus exemestane, a hormonal therapy, more than doubled the time ...

Zometa reduces risk of Breast Cancer recurrence in post-menopausal patients

A Phase III trial investigating the use of Zometa (zoledronic acid), from Novartis, to aid chemotherapy for Breast Cancer has found a significant benefit for post-menopausal women. The AZURE trial recruited 3,360 patients with stage II/III breast cancer and an interim analysis indicated that patients were seeing no clinical benefit from treatment with Zometa so the data were released for ...

FDA approves Kombiglyze XR for Type 2 diabetes

On 5th November 2010 the FDA approved Kombiglyze XR from BMS/AstraZeneca, for the treatment of type 2 diabetes in adults. Kombiglyze is the first and only once-a-day metformin extended-release (XR) plus dipeptidyl peptidase-4 (DPP-4) inhibitor combination tablet offering strong glycaemic control across glycosylated haemoglobin levels (HbA1c), fasting plasma glucose (FPG) and post-prandial glucose (PPG). Kombiglyze XR is indicated as an ...

CHMP recommends Komboglyze combination for Type 2 Diabetes

AstraZeneca and Bristol-Myers Squibb Company announced that the Marketing Authorisation Application for Komoboglyze (saxagliptin and metformin HCl immediate-release fixed dose combination) received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP), as an adjunct to diet and exercise, for the treatment of Type 2 Diabetes in adults who are not adequately controlled on metformin or those ...

Tradjenta shows long term benefits for Type 2 Diabetes patients

Results of a two-year Phase III study of Tradjenta (linagliptin), from Boehringer and Eli Lilly, show significant reductions in blood glucose for adults with Type 2 Diabetes. Presented at the 47 th Annual Meeting of the European Association for the Study of Diabetes, the study revealed the efficacy and tolerability of Tradjenta as mono-, dual- (plus metformin or initial combination ...

Ostora oral calcitonin safe and effective for Osteoporosis

The Phase III ORACAL trial evaluating Ostora tablets (calcitonin oral), from Tarsa Therapeutics, for the treatment of postmenopausal Osteoporosis, has yielded positive safety and efficacy results, according to data presented at the American Society for Bone and Mineral Research 2011 Annual Meeting. The trial compared Tarsa's oral recombinant salmon calcitonin to placebo and to commercially available, synthetic salmon calcitonin administered ...

Cellnovo recieves CE mark for Type 1 Diabetes management system

Cellnovo has received CE Mark approval for its Cellnovo mobile diabetes management system, aimed at patients with Type 1 Diabetes. Cellnovo's system uses mobile, wireless technology, and includes an insulin patch pump, a wireless, touch screen handset with a built-in blood glucose monitor, and an extendable applications software system. According to the comany, the system's rechargeable patch pump is the ...

SHOTZ study shows Forteo more effective than Zometa in bone remodelling

Data from the SHOTZ study were compared showing the mechanisms of action of Forteo (teriparatide [rDNA origin] injection) from Eli Lilly and zoledronic acid (Zometa) from Novartis that evaluated histomorphometric measurements of bone remodeling in transiliac crest bone biopsies from postmenopausal women with osteoporosis. These data were presented in an oral presentation at the 2011 Annual Meeting of the American ...

Galvus achieves significant improvements in Type 2 Diabetes study

New results on Galvus (vildagliptin), from Novartis, reveals that the drugf has a similar safety profile to placebo when added to anti-diabetic therapy in patients with Type 2 Diabetes and moderate or severe renal impairment. The study, presented at the 47th Annual Meeting of the European Association for the Study of Diabetes, also indicates that added to current therapy, Galvus ...

Protelos risk benefit profile in PMO questioned

The transparency committee at the French health authority, HASe has been investigating pharmacoviligence data on Protelos( strontium ranelate) from Servier to see if its risk benefit profile needs to change. The drug has been associated with hyperesenitivity reactions such as rash, eosinophilia , systemic syndromes (DRESS)(16 cases) and Stevens Johnson Syndrome. EMA was critical of the Servier pharmacovigilence system and ...

Tradjenta shows long term benefits for Type 2 Diabetes patients

Results of a two-year Phase III study of Tradjenta (linagliptin), from Boehringer and Eli Lilly, show significant reductions in blood glucose for adults with Type 2 Diabetes. Presented at the 47 th Annual Meeting of the European Association for the Study of Diabetes, the study revealed the efficacy and tolerability of Tradjenta as mono-, dual- (plus metformin or initial combination ...

Bydureon reduces cardiovascular risk factors in Type 2 Diabetes patients

Patients receiving Bydureon (exenatide extended release), a drug for Type 2 Diabetes from Amylin, Eli Lilly and Alkermes experienced significant improvements in specific cardiovascular risk factors compared to patients who received more commonly prescribed treatments. The results show that patients receiving Bydureon experienced improvements related to body weight, abnormal blood pressure and abnormal lipid levels. The analysis from the DURATION-3 ...

TAK 875 a new treatment for Type 2 Diabetes enters Phase III

TAK 875 from Takeda is a new selective agonist of the G-protein-coupled receptor (GPR 40)which is expressed in pancreatic islet beta cells. The drug has entered Phase III studies in Japan for Type 2 Diabetes and Phase III trials are commencing in the USA and EU. Phase II data showed a significant lower incidence of hypoglycaemia compared to placebo and ...

Tradjenta launch for Type 2 Diabetes delayed in Germany

Florbetapir PET...

Provenge sales for Prostate Cancer disappoint Dendreon and lead to staff reduction

Dendreon will reduce its workforce by 500 employees( about one-quarter of its work force)as sales of its prostate cancer immunotherapy, Provenge(sipuleucel-T) have disappointed and are well short of its projections. The largest proposed job cuts are in manufacturing but the company is looking for a partner in Europe as its moves toward filing for approval of Provenge there by the ...

New study of Cervarix shows two doses are adequate against HPV types 16 and 18

A new study of Cervarix (papillomarvirus vaccine) from Glaxo Smith Kline, finds that to protect women from HPV types 16 and 18, which account for 70% of cervical cancer cases, two doses of the vaccine are as effective as the standard three doses over a four-year period. The study, reported in The Journal of the National Cancer Institute, uses data ...

Afinitor success in BOLERO 2 study in advanced Breast Cancer

An interim analysis of a pivotal Phase III study BOLERO 2, showed Afinitor (everolimus) tablets from Novartis used in combination with exemestane significantly extended progression-free survival (PFS), or time without tumor growth, when compared to placebo plus exemestane in women with advanced breast cancer. The trial was stopped early after interim results showed the primary endpoint of PFS was met. ...

Insulin Degludec success in Types 1 and 2 Diabetes

Ultra-long acting insulin degludec, under development by Novo Nordisk, lowers blood glucose levels with significantly reduced rates of hypoglycaemia (low blood sugar) compared to insulin glargine, according to data presented at the 71st Scientific Sessions of the American Diabetes Association (ADA) in San Diego. The advantage of Insulin Degludec is that it has a duration of action that lasts up ...

FDA approves Roche Cobas HPV Test

The FDA has approved the cobas HPV (Human Papillomavirus) Test which identifies women at highest risk for developing cervical cancer. This test should help physicians make early, more accurate decisions about patient care, which may prevent many women from developing this deadly disease. The cobas HPV Test is the only FDA-approved cervical cancer screening test that allows HPV 16 and ...

Menerba from BioNovo enters Phase III for menopause

BioNovo Inc.of Emeryville CA announced that it has received positive guidance from the FDA regarding the Company's Chemistry, Manufacturing and Controls plan for its lead drug candidate Menerba ,a novel selective estrogen receptor beta agonist. The FDA indicated its agreement with Bionovo's plan. This agreement provides the necessary groundwork for the Company to progress to pivotal Phase III clinical testing ...