Arena Pharmaceuticals has decided to take its drug application and go home. The drugmaker Friday said it was giving up for now on breaking through the European wall of resistance to its weight-loss drug Belviq. The company, which got FDA approval last year, yanked its application with little explanation.
Pfizer has big expectations for its oral rheumatoid arthritis treatment Xeljanz--about $3 billion worth. But those expectations were struck a serious blow when European Medicines Agency regulators Thursday turned it down for approval.
Novartis and its cancer drug Gleevec had one of those days that starts off not looking so good and then something comes along to turn things around.
Vivus wasn't expecting a warm reception from European officials, and those expectations bore out. The committee said it was worried about Qsiva's long-term effects on the heart and blood vessels, particularly because Qsiva contains the active ingredient phentermine, once notorious for its use in the fen-phen diet-pill combo. Phentermine isn't approved in Europe, though it is in the U.S.
Novartis ($NVS) got what it had hoped for Friday, a thumbs up from the EU's Committee for Medicinal Products for Human Use (CHMP) for a new use for its cancer drug Afinitor. The CHMP recommended it for use in women with advanced breast cancer.
GlaxoSmithKline's meningitis vaccine Nimenrix has been granted approval in Europe by the Committee for Medicinal Products for Human Use (CHMP).
A top regulator suddenly bowed out at the European Medicines Agency, as his other employer--France's drug agency AFSSAPS--continues to draw fire.
The EU's Committee for Medicinal Products for Human Use has recommended that Roche 's Zelboraf be granted full marketing authorization to treat adults with BRAF V600 mutation-positive unresectable or
Three drugs recently approved in the U.S. to great fanfare have now won recommendations for sale in Europe. The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use gave
European regulators are gathering more info about Avandia safety. The European Medicines Agency convened an unexpected meeting of its advisory committee yesterday to discuss the diabetes drug, and