17:31 , Nov 9, 2018 |  BC Week In Review  |  Clinical News

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

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...
20:43 , Nov 6, 2018 |  BC Innovations  |  Distillery Therapeutics

Cancer

INDICATION: Adenocarcinoma Mouse studies suggest dual inhibition of MCL1 and MEK could help treat KRAS-mutant adenocarcinoma. In seven patient-derived xenograft (PDX) mouse models of KRAS-mutant adenocarcinoma, the MCL1 inhibitor AMG 176 plus the MEK inhibitor...
00:34 , Nov 3, 2018 |  BioCentury  |  Finance

Part B exposure

HHS Secretary Alex Azar's proposed changes to Medicare Part B have put at least four large biopharmas at risk of substantial U.S. revenue losses. But the lack of market reaction and the views of VCs...
21:15 , Nov 2, 2018 |  BC Extra  |  Company News

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

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...
19:55 , Nov 2, 2018 |  BC Week In Review  |  Clinical News

FDA approves Coherus' Neulasta biosimilar

Coherus Biosciences Inc. (NASDAQ:CHRS) said FDA approved Udenyca pegfilgrastim-cbqv to treat cancer patients receiving myelosuppressive chemotherapy. Udenyca is the second FDA-approved biosimilar of neutropenia drug Neulasta drug pegfilgrastim. The European Commission also approved Udenyca for...
19:51 , Nov 2, 2018 |  BC Week In Review  |  Clinical News

BCMA race heats up as ASH abstracts released

Abstracts released ahead of next month's American Society of Hematology meeting highlighted the competition among products representing three anti-BCMA (TNF receptor superfamily member 17; TNFRSF17; CD269) modalities in development to treat multiple myeloma. On the...
17:32 , Nov 2, 2018 |  BC Extra  |  Politics & Policy

China finalizes list of foreign drugs eligible for Priority Review

China’s Drug Evaluation Center posted its final list of 40 drugs approved in the U.S., EU or Japan that are eligible for Priority Review in China. On Aug. 8, the center announced the preliminary list...
22:38 , Nov 1, 2018 |  BC Extra  |  Company News

Management tracks: CuraSen names Vargas CMO; plus Sosei, Casebia

Neurodegenerative disease start-up CuraSen Therapeutics Inc. (San Mateo, Calif.) hired Gabriel Vargas as its first CMO. Vargas led early development of migraine prophylactic Aimovig erenumab at Amgen Inc. (NASDAQ:AMGN), where he was most recently executive...
22:23 , Nov 1, 2018 |  BC Extra  |  Clinical News

BCMA race heats up as ASH abstracts released

Abstracts released ahead of next month's American Society of Hematology meeting highlighted the competition among products representing three anti-BCMA (TNF receptor superfamily member 17; TNFRSF17; CD269) modalities in development to treat multiple myeloma. On the...
22:43 , Oct 26, 2018 |  BioCentury  |  Finance

Earnings on deck

Earnings on deck...