Abbott, of Abbott Park, Ill., said the European Committee for Medicinal Products for Human Use issued a positive opinion for Humira (adalimumab) in adults with moderate to severely active ulcerative colitis who have not responded to, cannot tolerate or have medical contraindications to conventional therapies

Cell Therapeutics Inc., of Seattle, said the European Committee for Medicinal Products for Human Use (CHMP) gave a positive opinion on conditional approval of Pixuvri (pixantrone dimaleate) for non-Hodgkin's B-cell lymphomas

PregLem, a subsidiary of Gedeon Richter, recently received a positive opinion from the European Committee for Medicinal Products for Human Use for Esmya, a selective progesterone receptor modulator

Allos Therapeutics Inc., of Westminster, Colo., submitted its request for a reexamination of the European Committee for Medicinal Products for Human Use (CHMP)'s negative opinion regarding approval of Folotyn (pralatrexate injection) for peripheral T-cell lymphoma

Allos Therapeutics Inc., of Westminster, Colo., received a negative opinion from the European Committee for Medicinal Products for Human Use (CHMP) regarding approval of Folotyn (pralatrexate injection) for peripheral T-cell lymphoma

Ltd., of Osaka, Japan, said the European Commission has adopted the European Medicines Agency Committee for Medical Products for Human Use's opinion on pioglitazone-containing medicines, including Actos

Ltd., of Osaka, Japan, said the European Commission has adopted the European Medicines Agency Committee for Medical Products for Human Use's opinion on pioglitazone-containing medicines, including Actos

Gentium SpA, of Villa Guardia, Italy, said it received the list of questions from the European Committee for Medicinal Products for Human Use in response to its marketing application for defibrotide to treat and prevent hepatic veno-occlusive disease in adults and children undergoing hematopoietic stem cell transplantation therapy

Gentium SpA, of Villa Guardia, Italy, said it received the list of questions from the European Committee for Medicinal Products for Human Use in response to its marketing application for defibrotide to treat and prevent hepatic veno-occlusive disease in adults and children undergoing hematopoietic stem cell transplantation therapy

The goal is then to license promising candidates to other pharmaceutical companies for advanced clinical development and commercialization...In other news, GSK and Human Genome Sciences Inc., of Rockville, Md., said they started dosing in BLISS-SC, a new Phase III trial of Benlysta (belimumab) administered subcutaneously once weekly to autoantibody-positive adults with active systemic lupus erythematosus (SLE

BioMarin Pharmaceutical Inc., of Novato, Calif., said the European Medicines Agency's Committee for Medicinal Products for Human Use recommended approval for the company's manufacturing facility expansion in Novato

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