WASHINGTON – Biopharma has cause to celebrate as PDUFA V rolled through the Senate Thursday with little in the way of fireworks. The FDA Innovation and Safety Act (FDASIA), S. 3187, passed the Senate 96-1 after a full day of debate on various amendments. Read More
Members of the FDA's Peripheral and Central Nervous System (PCNS) Drugs Advisory Committee delivered a split opinion Thursday on the use of a single study by sponsor Pfizer Inc., which is seeking approval for Vyndaqel (tafamidis meglumine) in the orphan indication transthyretin (TTR) familial amyloid polyneuropathy (FAP). Read More
A Phase IIb trial intended to show the benefit of MediciNova Inc.'s asthma candidate, MN-221, failed to meet its primary endpoint of improved forced expiratory volume in one second (FEV1) compared to placebo, sending the company's stock plummeting 43.3 percent Thursday. Read More
Celldex Therapeutics Inc. is eyeing an accelerated approval pathway after preliminary Phase IIb data showed impressive response rates in three subsets of heavily pretreated breast cancer patients given glycoprotein NMB (GPNMB)-targeting antibody-drug conjugate CDX-011 (glembatumumab vedotin). Read More
• Catalyst Pharmaceutical Partners Inc., of Coral Gables, Fla., said it priced a public offering of 6 million units – each unit comprising one share of common stock and a warrant to purchase up to one share – at 80 cents apiece. Read More
• Gilead Sciences Inc., of Foster City, Calif., said the European Medicines Agency validated its marketing authorization application (MAA) for cobicistat, submitted on April 26. Cobicistat is Gilead's pharmaco-enhancing agent to increase blood levels of certain commercially available protease inhibitors, including atazanavir (Reyataz, Bristol-Myers Squibb Co.) and darunavir (Prezista, Tibotec Pharmaceuticals), to enable once-daily dosing. Read More
• Bionomics Ltd., of Adelaide, Australia, said it launched a Phase I/II trial of BNC105 in women with ovarian cancer. Up to 134 patients are expected to be enrolled in the study, which is designed to test the vascular-disrupting agent in combination with current standard therapies carboplatin and gemcitabine. Read More
• Boehringer Ingelheim Pharmaceuticals Inc., of Ridgefield, Conn., and Eli Lilly and Co., of Indianapolis, reported Phase III results for Tradjenta (linagliptin) 5 mg once-daily, which showed significant hemoglobin A1c reduction of 0.88 percent compared with 0.24 percent in the placebo group at 24 weeks. Read More
• Mylan Inc., of Pittsburgh, said its UK and Italy-based subsidiaries launched ibandronic acid film coated tablets, the generic version of Basel, Switzerland-based Roche AG's Bonviva tablets, in osteoporosis. Read More
