AstraZeneca and Bristol-Myers grabbed a win in the EU today for one of the drugs sprung from their diabetes treatment partnership. But the recommended approval comes even as questions have bubbled up about the future of that relationship.
Drugmaker Ariad left its European operations untouched last month when it took an ax to its workforce after the FDA requested it pull its leukemia drug Iclusig off the market in the U.S. Regulators in the EU did not make the same request, but they also did not ignore the clotting risks that raised a red flag at the FDA.
Friday, the EU's Committee for Medicinal Products for Human Use (CHMP) recommended 11 new drugs for a variety of diseases--the most nods it's given in a single meeting all year.
In the two years since cancer vaccine maker Dendreon sent its share price into a precipitous decline by pulling the forecast on its debut drug, Provenge, bad news has mounted up. Weak sales drove shares down 30% last year, and the slide has continued in 2013.
It was a very, very big week in Europe for drugmakers. The European Committee for Medicinal Products for Human Use (CHMP) recommended 10 drugs for approval, including two biosimilars, it said today.
Dendreon today got the best news it has had in a long time for its prostate cancer vaccine Provenge, a thumbs up from the Europe's Committee for Medicinal Products for Human Use (CHMP) for approval in Europe.
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.