The commissioners’ concerns are in response to sweeping vaccine regulation changes earmarked by CBER head Vinay Prasad.
Completion of the agreement remains contingent on several closing conditions.
The companies will jointly develop IBI363 on a global scale and co-commercialise the therapy in the US.
The pharma industry has called the IRA “price setting” and argues that negotiations have not cut out-of-pocket costs for patients.
Høeg’s appointment to director of CDER follows a turbulent period for the department, which recently saw the retirement of former head, Richard Padzur.
The decision broadens Jaypirca’s label and converts the December 2023 accelerated approval to a traditional approval status.
