Bristol and AstraZeneca lost major PPAR diabetes product development projects. Both companies got a nasty taste of a rapidly emerging force in the drug development process: the academic research organization. These academic centers are not shy about expressing their negative as well as positive opinions on drug development plans. Leading the pack is the Cleveland Clinic - the source of the safety questions that finished off the PPAR class.
Cole Werble
The pen is mightier than an FDA review—or at least it probably feels that way to PPAR drug developers.
Join thousands of industry professionals who rely on Pink Sheet for daily insights
Already a subscriber?
Robert Foster, HHS deputy general counsel and chief counsel for food, research and drugs, is temporarily heading the Office of Chief Counsel, but a permanent appointee is expected after Michael Stuart's confirmation as HHS general counsel.
Cell and gene therapy developers may not have to contend with HHS Secretary Robert F. Kennedy Jr.’s animosity like the traditional pharma industry, but his disinterest in distinguishing between the good and bad actors in the space could backfire.
The group had been laid off as part of the 1 April reduction-in-force, which lead to missed guidance publication deadlines.
The developers of the ChAdOx1 NipahB vaccine will be able to benefit from the early and enhanced support that the European Medicines Agency offers through its priority medicines scheme.
In a somewhat surprising move, President Trump’s Federal Trade Commission is continuing a crusade to delist improper listings from the FDA’s Orange Book. Law firm Polsinelli’s chair Chad Landmon discussed the impact of the move on the generic drug industry.
Cell and gene therapy developers may not have to contend with HHS Secretary Robert F. Kennedy Jr.’s animosity like the traditional pharma industry, but his disinterest in distinguishing between the good and bad actors in the space could backfire.
With a 25-27 June meeting looming, HHS Secretary Robert F. Kennedy Jr. can fill all 17 spots on the CDC's Advisory Committee on Immunization Practices with people he says will "exercise independent judgment."
