Obesity Guidance Should Be More Lenient On Indications, Firms Tell FDA
Executive Summary
A stipulation that patients should fail lifestyle modifications before they are eligible to enroll in clinical trials for obesity drugs needs to be modified, according to industry comments on an FDA draft guidance on development of weight management drugs
You may also be interested in...
Arena Airs More Mixed Data For Late-Stage Obesity Drug Lorcaserin
New Phase III data for Arena Pharmaceuticals' novel obesity compound lorcaserin have disappointed the market once again, even though the company is arguing that technically speaking, they will do the trick in satisfying guidelines for FDA approval
Arena Airs More Mixed Data For Late-Stage Obesity Drug Lorcaserin
New Phase III data for Arena Pharmaceuticals' novel obesity compound lorcaserin have disappointed the market once again, even though the company is arguing that technically speaking, they will do the trick in satisfying guidelines for FDA approval
Obesity Déjà Vu: Arena Airs More Mixed Phase III Data
Results raise doubts about prospects for regulatory approval and competitive positioning.