Pharmaceuticals are at the heart of two trade deals now being hammered out by Europe, one with Canada and the other with Israel. The deals could provide some additional benefits to drugmakers in a difficult global market, but neither deal is assured.
Orexigen Therapeutics wound up playing catch-up with its two rivals in the race to develop the first new weight drug in more than a decade. But it has the pedal to the metal in a late-stage drive to win a speedy regulatory approval and start competing for the growing obesity market in the U.S.
Edwards Lifesciences ($EW) won a long-awaited expanded FDA approval to use its Sapien transcatheter aortic heart valve in a larger class of patients. The vote became likely in June, when an FDA panel of experts voted 11-0, with one abstention, that benefits of a broader indication outweighed any risks.
Eli Lilly ($LLY) is on the verge of gaining approval in the European Union to use its radioactive diagnostic agent Amyvid as a tool to detect Alzheimer's related brain plaque buildup, 6months after U.S. regulators granted a similar approval.
The tepid 9-6 vote from an FDA advisory panel left the new drug application looking relatively weak compared with a 13-2 vote for rival treatment lomitapide from Aegerion Pharmaceuticals.
The day Sanofi has dreaded is coming. Novo Nordisk won European backing for its new insulin, Tresiba, the drug that could become Lantus' nemesis. If Tresiba wins final European Medicines Agency approval, then Sanofi ($SNY) will be battling fiercely for market share.
The Committee for Medicinal Products for Human use nixed Vivus' application for approval, citing worries about Qsiva's safety and probable off-label use.
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.
Novo Nordisk scored a thumbs-up from a European Union advisory panel for its long-acting insulin degludec, pushing the pharma company down the road to a key new potential approval that could reshape the fast growing $35 billion market for diabetes drugs. The insulin--now bearing the brand name Tresiba--is aimed squarely at stealing market share from Sanofi's Lantus and is slated for an FDA panel review on November 8.
Complete Genomics notched a legal victory in its patent squabble with Illumina, as a federal judge threw out 9 of Illumina's infringement claims.