Almirall SA, of Barcelona, Spain, said the European Committee for Medicinal Products for Human Use issued a positive opinion for Eklira Genuair (aclidinium) as a maintenance bronchodilator treatment to relieve symptoms in adults with chronic obstructive pulmonary disease...Eisai Inc., of Woodcliff Lake, N.J., said the European Committee for Medicinal Products for Human Use issued a positive opinion for Fycompa (perampanel) as an adjunctive treatment of partial-onset seizures, with or without

Boehringer Ingelheim GmbH, of Ingelheim, Germany, and Eli Lilly and Co., of Indianapolis, said they received a positive opinion from the European Committee for Medicinal Products for Human Use for Jentadueto, which combines DPP-4 inhibitor linagliptin (the active ingredient in Trajenta) and metformin in a single tablet

Vertex Pharmaceuticals Inc., of Cambridge, Mass., received a positive opinion from the European Committee for Medicinal Products for Human Use for approval of Kalydeco (ivacaftor) for cystic fibrosis in those age 6 and older with at least one copy of the G551D mutation

In other news, Gentium said it received the Day 180 list of outstanding issues from the European Committee for Medicinal Products for Human Use in connection with the marketing authorization 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 Day 180 list of outstanding issues from the European Committee for Medicinal Products for Human Use in connection with the marketing authorization application for Defibrotide to treat and prevent hepatic veno-occlusive disease in adults and children undergoing hematopoietic stem cell transplantation therapy

Novartis AG, of Basel, Switzerland, received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) for Jakavi (ruxolitinib), its myelofibrosis treatment

Novartis AG, of Basel, Switzerland, received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) for Jakavi (ruxolitinib), its myelofibrosis treatment

Ltd., of Osaka, Japan, said the European Committee for Medicinal Products for Human Use issued a positive opinion for ferumoxytol, an intravenous iron therapy, with a proposed indication for the treatment of iron deficiency anemia in adults with chronic kidney disease...SkyePharma plc, of London, reported Friday that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion recommending granting of a marketing authorization

The decision follows a positive recommendation from the Committee for Medicinal Products for Human Use late last year...Shire plc, of Dublin, Ireland, said the European Committee for Medicinal Products for Human Use approved the production of Vpriv (velaglucerase alfa) in the firm's new manufacturing facility in Lexington, Mass

The decision follows a positive recommendation from the Committee for Medicinal Products for Human Use late last year

Shire plc, of Dublin, Ireland, said the European Committee for Medicinal Products for Human Use approved the production of Vpriv (velaglucerase alfa) in the firm's new manufacturing facility in Lexington, Mass

Gentium SpA, of Villa Guardia, Italy, responded to the day 120 list of questions from the European Committee for Medicinal Products for Human Use regarding defibrotide in the treatment and prevention of hepatic veno-occlusive disease in patients undergoing hematopoietic stem cell transplantation

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

Amylin Pharmaceuticals Inc., of San Diego, and Eli Lilly and Co., of Indianapolis, said the European Committee for Medicinal Products for Human Use issued a positive opinion for expanded use of Byetta (exenatide twice-daily) for treatment of Type II diabetes...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

Furiex Pharmaceuticals Inc., of Morrisville, N.C., said the European Commission (EC) endorsed a positive opinion adopted by the Committee for Human Medicinal Products Oct. 18, 2011, regarding Prilogy (dapoxetine) 30-mg and 60-mg doses for use in premature ejaculation in men between the ages of 18 and 64

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...Amsterdam Molecular Therapeutics NV, of Amsterdam, the Netherlands, reported that rather than approve the Committee for Human Medicinal Products' recommendation to deny marketing authorization for Glybera (alipogene tiparvovec), the

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

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