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Latest From Bavarian Nordic A/S
Keeping Track: Keytruda Adds TNBC Claim; Finerenone, Brincidofovir, HTX-011 Submitted; CRL For Supernus’ ADHD Drug
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
Deal Watch: Merck Gets Rights To Yumanity’s Preclinical ALS, FTLD Candidates
Merck pays undisclosed upfront fees and promises up to $500m for milestones under licensing and collaboration agreement. Meanwhile, Tetraphase and Xerava are being acquired by La Jolla, after previous bids by Melinta and AcelRx.
Coronavirus Efforts Could Benefit From Little-Used Medical Countermeasures Incentives
US FDA’s Medical Countermeasures Initiative authorities like emergency use authorization have not yet had much of an impact on drugs and biologics, but agency is committed to supporting a swift response to the new strain of coronavirus.
Vaccines Boost Priority Profile Of US FDA’s Biologic Center 2019 Approvals
Tropical diseases were not neglected by the Center for Biologics Evaluation and Research in 2019, producing three novel vaccines (which earned three priority review vouchers) and tilting the approval class toward expedited review programs.
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