FDA Will Soon Finalize Obesity Guidance, May Tackle CV Safety Separately
Executive Summary
The fuzzy regulatory picture for the challenging obesity space is about to come into focus with two actions from FDA: the agency is expected to issue final guidance on weight management drug development soon and, later, may consider requirements for proof of cardiovascular safety, in the vein of the recent guidance on diabetes drugs
You may also be interested in...
Type 2 Diabetes Developers Take Heart: New Safety Hurdle Is Surmountable
The April 1-2 meeting of the Endocrinologic & Metabolic Drugs Advisory Committee ended in equivocal results for the sponsors involved, but sends an unequivocal message of hope to diabetes drug development companies: the new cardiovascular safety bar adopted by FDA in December is surmountable
Arena, Like Rivals, Greets Mixed Phase III Obesity Results With Brave Face
Arena's release this week of surprisingly disappointing results for its obesity drug lorcaserin raises more questions about what "efficacy" means in the highly competitive space, and about the flexibility of FDA guidance for weight-management products
VCs Think Twice About Type 2 Diabetes Investments
Venture capitalists are reevaluating type 2 diabetes investments in light of daunting new regulatory hurdles and an economic climate that limits their ability to cash out of such companies in a timely fashion. But, say some VCs, truly innovative compounds may be worth the bigger R&D bills and longer time to exit given the dazzlingly large market at stake