BioCentury
ARTICLE | Company News

FDA approves AcelRx, Coherus, Pfizer products, rebuffs Trevena's Olinvo

November 2, 2018 9:15 PM UTC

FDA approved products from Coherus Biosciences Inc. (NASDAQ:CHRS), AcelRx Pharmaceuticals Inc. (NASDAQ:ACRX) and Pfizer Inc. (NYSE:PFE) on Friday, but issued a complete response letter to an NDA from Trevena Inc. (NASDAQ:TRVN).

Coherus was up $0.70 to $12.20 Friday when it scored its first FDA approval. The agency approved Udenyca pegfilgrastim-cbqv to treat cancer patients receiving myelosuppressive chemotherapy. Udenyca is the second FDA-approved biosimilar of neutropenia drug Neulasta drug pegfilgrastim from Amgen Inc. (NASDAQ:AMGN). Udenyca is also approved in Europe for the indication. ...