Elan/Biogen Idec's Tysabri, Formerly Antegren, Approved For MS Based On One-Year Data
This article was originally published in The Pink Sheet Daily
Monoclonal antibody's label includes studies as monotherapy and as add-on in patients previously treated with Avonex. Two-year results are expected in the first half of 2005.
You may also be interested in...
CDER’s Bob Temple explains how competitors could actually help speed up a drug approval but also hold a product to a higher standard.
The durability of treatment effect for Chelsea’s NOH drug is an issue for a post-marketing study to answer, FDA’s Cardiovascular and Renal Drugs Advisory Committee said in recommending approval on a 16-1 vote.
Clinical hold on the Phase II trial was lifted “within the last six months” and dosing completed, Genzyme’s Enyedy says.