BioCentury
ARTICLE | Clinical News

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

November 9, 2018 5:31 PM UTC

FDA approved products from Coherus Biosciences Inc. (NASDAQ:CHRS), AcelRx Pharmaceuticals Inc. (NASDAQ:ACRX) and Pfizer Inc. (NYSE:PFE) on Nov. 2, but issued a complete response letter to an NDA from Trevena Inc. (NASDAQ:TRVN).

Coherus was up $0.70 to $12.20 Nov. 2 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...