Current Editions
Prasad’s memo, Makary’s vouchers trigger Pazdur’s exit from FDA
The CDER director’s departure reflects deep problems at the agency
Regulation
FDA’s Vinay Prasad, in his own words
CBER director’s ‘Black Friday memo’ has broad implications for public health, vaccine manufacturers
Politics, Policy & Law
Product Development
Janux shares halve despite still strong Phase I data
Clinical trial updates for the week of Nov. 25 - Dec. 2
Data Byte
FDA’s docket holds 16 more PDUFA dates by year-end
Including eight opportunities to add to the annual NME count
Politics, Policy & Law
New U.K.-U.S. trade deal eases industry rebate burden
Deal also secures 0% tariffs on U.K. pharma exports and a small increase in the NICE cost-effectiveness threshold
Deals
Regeneron, Tessera to advance gene editing therapy for AATD: Deals Report
Plus: A step forward for Alkermes-Avadel, Akebia buys Q32’s complement therapy, and more
Management Tracks
Durso succeeding Garg as Altimmune CEO
Plus: Updates from Circle, NRG, Ovid and Tacalyx
BioCentury ISSN 1097-7201