In addition to the usual details about user fees, the latest reauthorization of the PDUFA package passed by the House and Senate also includes special incentives for antibiotic drugs.
Latin America is developing into an important geographic focus for drug companies. Through acquisitions and strategic partnerships, companies are positioning themselves to grab a slice of this expanding market.
After positive recommendations from the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) for both Vivus Inc.'s Qnexa (phentermine/topiramate) and Arena Pharmaceuticals Inc.'s lorcaserin, it looks like both drugs will get past the FDA on their second attempts.
The Ewing Marion Kauffman Foundation issued a report this month blaming the lackluster returns from venture capital on a lack of oversight from limited partners (LPs) that invest in the funds.
Data presented at the 2012 International Liver Congress of the European Association for the Study of the Liver last month showed Gilead Sciences Inc.'s nuc drug GS-7977 works well with Bristol-Myers Squibb Co.'s NS5A inhibitor daclatasvir.
In conjunction with Eli Lilly and Co.'s recent FDA approval of Amyvid (florbetapir), Safeguard Scientifics Inc. received a $5.6 million earn-out payment from its investment in Avid Radiopharmaceuticals Inc. before Lilly purchased the biotech.