Roche AG, of Basel, Switzerland, said the European Committee for Medicinal Products for Human Use recommended approval for Zelboraf (vemurafenib) as a monotherapy for adults with BRAF V600 mutation-positive unresectable or metastatic melanoma

Merck Serono SA, of Geneva, a division of Merck KGaA, said it received a positive opinion from the European Committee for Medicinal Products for Human Use to extend the label for Rebif (interferon beta-1a) to include three weekly doses of 44 mcg for patients who have experienced a single demyelinating event, an early sign of multiple sclerosis (MS), and who are at high risk of converting to MS

Merck Serono SA, of Geneva, a division of Merck KGaA, said it received a positive opinion from the European Committee for Medicinal Products for Human Use to extend the label for Rebif (interferon beta-1a) to include three weekly doses of 44 mcg for patients who have experienced a single demyelinating event, an early sign of multiple sclerosis (MS), and who are at high risk of converting to MS

In other news, Elan and Biogen said the FDA extended by three months the initial PDUFA date for its review of the supplemental biologics license application (sBLA) for Tysabri (natalizumab...Up to 55 percent of cases of wet AMD in Chinese, Japanese and Malay populations are caused by polypoid choroidal vasculopathy, which differs from

Pharmaxis Ltd., of Sydney, Australia, reported that the Committee for Medicinal Products for Human Use recommended the granting of a marketing authorization for Bronchitol, clearing the way for the product to be used in Europe as an add-on therapy to treat cystic fibrosis in adults

Mymetics Corp., of Epalinges, Switzerland regained its intranasal influenza vaccine from Solvay Pharmaceuticals Inc., now part of Abbott, of Abbott Park, Ill. Mymetics had licensed the vaccine to Solvay, which completed a successful Phase I study that found the vaccination was safe and well tolerated, and resulted in antibodies in the blood that exceeded the Committee for Medicinal Products for Human Use criteria for injected influenza vaccines

23 press release regarding the Committee for Medicinal Products for Human Use's Article 20 Review of multiple myeloma drug Revlimid (lenalidomide

Mymetics Corp., of Epalinges, Switzerland regained its intranasal influenza vaccine from Solvay Pharmaceuticals Inc., now part of Abbott, of Abbott Park, Ill. Mymetics had licensed the vaccine to Solvay, which completed a successful Phase I study that found the vaccination was safe and well tolerated, and resulted in antibodies in the blood that exceeded the Committee for Medicinal Products for Human Use criteria for injected influenza vaccines

Celgene International Sarl, of Boudry, Switzerland, said the European Committee for Medicinal Products for Human Use issued a positive opinion for Revlimid (lenalidomide) in combination with dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy

Eli Lilly and Co., of Indianapolis, received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use for the use of Alimta (pemetrexed for injection) as continuation maintenance therapy in patients with advanced nonsquamous non-small-cell lung cancer

Celgene International Sarl, of Boudry, Switzerland, said the European Committee for Medicinal Products for Human Use issued a positive opinion for Revlimid (lenalidomide) in combination with dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy

Cell Therapeutics Inc., of Seattle, submitted its response to questions raised by the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) in relation to the company's marketing authorization application for pixantrone to treat relapsed or refractory aggressive non-Hodgkin's lymphoma

Janssen-Cilag International NV, of Beerse, Belgium, a Johnson & Johnson subsidiary, said the European Committee for Medicinal Products for Human Use recommended approval of Zytiga (abiraterone acetate) under an accelerated review procedure in combination with prednisone or prednisolone for metastatic castration-resistant prostate cancer in adult men whose disease has progressed on or after a docetaxel-based chemotherapy regimen

Boehringer Ingelheim GmbH, of Ingelheim, Germany, and Eli Lilly and Co., of Indianapolis, received a positive opinion from the European Committee for Medicinal Products for Human Use recommending approval of Trajenta (linagliptin) in adults with Type II diabetes

Amgen Inc., of Thousand Oaks, Calif., said the Committee for Medicinal Products for Human Use adopted a positive opinion recommending EGFR-targeting Vectibix (panitumumab) be approved for use in first-line metastatic colorectal cancer (mCRC) in combination with FOLFOX and in second-line disease in combination with FOLFIRI in patients who have received first-line fluoropyrimidine-based chemotherapy (excluding irinotecan) and who have wild-type KRAS disease...ViroPharma Inc., of Exton, Pa., said the

The expected approval followed a positive recommendation by the Committee for Medicinal Products for Human Use in April

In other news, Astellas Pharma Europe Ltd., of Staines, UK, and Theravance Inc., of South San Francisco, announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency recommended the granting of marketing authorization for Vibativ (telavancin hydrochloride) for the treatment of adults with nosocomial pneumonia including ventilator-associated pneumonia, known or suspected to be caused by methicillin-resistant Staphylococcus aureus

Inc., of Whitehouse Station, N.J., announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency under accelerated assessment recommended approval of Victrelis (boceprevir) for the treatment of chronic hepatitis C virus genotype 1 infection, in combination with peginterferon alfa and ribavirin, in adult patients with compensated liver disease who are previously untreated or who have failed previous therapy

NicOx SA, of Sophia-Antipolis, France, withdrew its marketing authorization application for osteoarthritis candidate naproxcinod from the centralized procedure in Europe, citing feedback from a meeting of the Committee for Medicinal Products for Human Use (CHMP