Today's Top Story

FDA’s international cancer drug review initiative launches with first approval

FDA believes its new framework for the submission and review of cancer drugs concurrently in multiple countries will speed up patient access to new therapies and streamline drug development. The ...

Company News

Couple charged with stealing secrets to form Chinese, U.S. biotech companies

The Department of Justice has charged two scientists, Yu Zhou and Li Chen, with stealing trade secrets from Nationwide Children’s Hospital Research Institute and forming two companies based on the ...

Sept. 17 Company Quick Takes: Priority Review for Merck Ebola vaccine; plus Edgewise’s debut, Adaptive, AskBio and Acceleron

Merck Ebola vaccine granted Priority Review FDA accepted and granted Priority Review to a BLA from Merck & Co. Inc. (NYSE:MRK) for its Ebola vaccine V920 (rVSV-ZEBOV). The candidate has a PDUFA ...

Management tracks: Gottlieb joins Aetion board; plus Alexion, Encoded, PhRMA, Rgenix, Lyra, twoXAR and Innoplexus

Former FDA Commissioner Scott Gottlieb has joined the board of real-world evidence company Aetion Inc. Gottlieb was a champion of integrating real-world evidence into product development during his ...

Clinical News

Biogen stops Phase II for returned IPF candidate

Seven years after regaining rights to BG00011 (STX-100), Biogen terminated its Phase II trial of the mAb for idiopathic pulmonary fibrosis (IPF) due to safety concerns. Biogen Inc. (NASDAQ:BIIB) had ...

Financial News

Bayer invests $20M in One Drop's digital platform

As digital health's footprint continues to grow, Bayer is leading One Drop's $40 million series B round and licensing its diabetes self-management platform for use in other disease areas. Bayer AG ...

Politics & Policy

HHS report finds Part D rebates not keeping up with rising drug prices

An HHS Office of the Inspector General report shows Medicare Part D rebates are not keeping up with rising prices for brand drugs. The report examined 1,510 brand name Part D drugs that received ...

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