Riastap Advisory Committee Review Will Evaluate Surrogate Endpoint
This article was originally published in The Pink Sheet Daily
CSL Behring seeks accelerated approval for the first human fibrinogen concentrate since the products were withdrawn in 1977, but FDA first wants validation of the surrogate endpoint used to show efficacy.
You may also be interested in...
FDA is acknowledging that clinical benefit for patients with rare conditions may best be verified through post-marketing trials, given the difficulty of conducting clinical trials in those populations
The hits just keep on coming for Genzyme. On a March 2 call with investors, the firm had to announce not just a "complete response" letter for its 2000-liter scale-up of Myozyme (which will be called Lumizyme for the larger production scale), but also that its Allston Landing manufacturing site had received a 483 report from FDA and a subsequent warning letter