Polsinelli Podcasts - FDA Denies Amgen Citizen Petition in Biosimilar Dispute
CHMP Adopts Positive Opinion for Aflibercept, Pegfilgrastim Biosimilars: On January 30, 2025, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions recommending...more
To date, 2024 has not yet seen the type of mega-merger (Pfizer/Seagen) or level of agency enforcement (Sanofi/Maze or Amgen/Horizon) as 2023. But two notable investigations — one still active — show the Federal Trade...more
Despite an earlier White House promise to postpone, American and Chinese trade negotiators met via videoconference on Monday to discuss “the status of the trade deal both nations signed in January, a pact that continues to...more