Biotechnology Innovation Organization

BIO is engaging Trump to protect and improve FDA, hoping to dodge tariffs, looking for paths to modify IRA and reinstate PRVs

AdvaMed calls out FDA cuts as PhRMA lauds Trump as ‘disruptor in chief’

Cuts to NIH funding foreshadow bigger challenges for biomedical research, tough trade-offs for biotech and pharma companies

The BioCentury Show: Washington Editor Steve Usdin breaks down why this transition is different for FDA from previous ones, and Trump 2.0’s other impacts for biopharma

Plus: Lange becomes CBO of Avidity and updates from CABS, BIO, Zevra and Achieve

Rhodium Group report suggests Congress focus on economic rather than military threats from China biotech

Plus: Nxera names BMS vet Sugita CMO, Japan president, and updates from Achieve, Every Cure and more 

Comments on the agency’s guidance document include requests that it extend the designation to platforms that have yet to yield an approved drug

Application fee set to increase to $4.3M, would have been $5M using old formula

Rare Disease Innovation Hub intended to bridge centers, serve as single point of contact for rare disease community, coordinate research