For the interim analysis of its Phase II study combining VX-809 and Kalydeco (ivacaftor) in cystic fibrosis patients homozygous for the F508del mutation, Vertex Pharmaceuticals Inc. presented data pooled from the three doses from baseline to day 56 of the trial. The release of the final top-line data for study contained efficacy data for just the largest 600 mg dose of VX-809 with Vertex highlighting the improvement in lung function from day 28 to 56.
Summer is upon us. Or so I hear from news reports of heat waves and thunderstorms. Living in San Diego, we don't have summer, nor winter, nor fall. Venture capital investing, on the other hand, isn't nearly as hot. After the first quarter of 2012 that was a wildfire relative to 2011, the second quarter didn't keep pace and saw us slip below 2011 levels.
Following Arena Pharmaceuticals Inc.'s big win for obesity drug Belviq (lorcaserin), Vivus Inc.'s Qnexa (phentermine/topiramate) is next in line. And, with a positive recommendation from the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) that drug also looks like it will get past the FDA on its second attempt.
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.
