Fred Hutchinson Cancer Research Center hired Thomas Lynch as president and director, effective next month. Lynch was CSO of Bristol-Myers Squibb Co. (NYSE:BMY). He succeeds Gary Gilliland, who announced in September his plans to step...

CMS appointed Brad Smith as director of the Center for Medicare & Medicaid Innovation , through which HHS plans to implement the Trump administration’s proposed International Pricing Index model for Medicare Part B drugs. Smith, who...

Monday's basket of regulatory news includes two landmark regulatory applications for BioMarin's hemophilia gene therapy in the U.S. and EU, and FDA approval of Allergan's migraine drug. BioMarin Pharmaceutical Inc. (NASDAQ:BMRN) submitted a BLA to...

Label expansion for AZ’s Calquence under Project ORBIS  FDA approved an sNDA for Calquence acalabrutinib from AstraZeneca plc (LSE:AZN; NYSE:AZN) to treat chronic lymphocytic leukemia and small lymphocytic leukemia under the agency’s Real-Time Oncology Review...

Qiagen confirms acquisition interest  Qiagen N.V. (NYSE:QGEN; Xetra:QIA) said Friday it is reviewing its strategic alternatives after receiving several “non-binding indications of interest for the acquisition” of the diagnostics company. Since acquisition rumors emerged Wednesday,...

Shionogi & Co. Ltd. (Tokyo:4507) said FDA’s Antimicrobial Drugs Advisory Committee on Wednesday recommended approving Fetroja cefiderocol to treat complicated urinary tract infections including pyelonephritis caused by Gram-negative bacteria in patients with limited or no...

Imbalance in deaths likely focus of Shionogi advisory panel meeting  Briefing documents for an Oct. 16 meeting of FDA’s Antimicrobial Drugs Advisory Committee to discuss IV cefiderocol from Shionogi & Co. Ltd. (Tokyo:4507) to treat...

The heyday of digital health may not yet even be on the horizon, but investments in the field are certainly starting to hit the radar in the areas most likely to impact patients first --...

PharmaMar seeking accelerated approval of SCLC candidate PharmaMar S.A. (Madrid:PHM) climbed €0.46 (29%) to €2.06 after the company said that based on the results of dialogue with FDA, it will submit an NDA next quarter...

Cancer immunotherapy company Iovance Biotherapeutics Inc. (NASDAQ:IOVA) hired Friedrich Graf Finckenstein as CMO. He was global head of oncology translational medicine of the Pharma Research and Early Development (pRED) unit of Roche (SIX:ROG; OTCQX:RHHBY). ViiV...