In August, Sanofi's Genzyme won the FDA's blessing to take brand-new orphan drug Cerdelga into the U.S. Gaucher disease market, where the company hoped the pill could show up older, intravenous treatments. And now, it could be on its way to the same opportunity in the EU.
Boehringer Ingelheim's Ofev and Roche's Esbriet became the first two U.S.-approved treatments for idiopathic pulmonary fibrosis when the FDA green-lighted them on the same day last month. And while Roche has the lead with Esbriet in Europe, Boehringer is now one step closer to leveling the playing field on the continent.
When Europe's drug approval gatekeepers meet, they often tick off recommendations for some key Big Pharma products. This week, the Committee for Medicinal Products for Human Use backed a whopping 15 new meds and 3 new indications.
The EU Committee for Medicinal Products for Human Use (CHMP) handed down a positive ruling on Roche's blockbuster Avastin, recommending that the European Commission approve the drug for use in women with ovarian cancer that's resistant to platinum-based chemotherapy.
Gazyva, Roche's successor to Rituxan, is already approved in the U.S. for first-line use on chronic lymphocytic leukemia (CLL) and appears poised for the same in Europe. The EU Committee for Medicinal Products for Human Use (CHMP) today recommended it for approval there.
Swiss drugmaker Novartis got a mixed bag of news from European regulators Friday. It got a recommendation for its asthma drug Xolair to treat a chronic form of hives. Regulators, however, slapped down its new heart drug serelaxin, a product that Novartis is counting on bringing in more than a billion dollars a year.
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.