• ReconRecon

    Recon: EMA recommends Valneva COVID vaccine; Novartis wins FDA approval for Tafinlar + Mekinist combo

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Biogen, citing insurance challenges, shutters one of its Aduhelm studies ( BioPharmaDive ) U.S. FDA labels Baxter's respiratory device recall as most serious ( Reuters ) Novartis wins U.S. approval for targeted cancer drug combination ( Reuters ) Despite fanfare, the FDA’s step toward lowering nicotine levels in cigarettes is a very early one ( STAT ) U.S. FD...
  • Regulatory NewsRegulatory News

    Following Negative Comments by Reviewer, EU Committee OK's Gene Therapy

    Last month, German regulators postponed their review of UniQure's gene therapy Glybera after the European Medicines Agency (EMA) rapporteur assigned to the product claimed new data showed Glybera lacked efficacy and called for it to be reassessed . Now, EMA's Committee for Advanced Therapies (CAT) has completed its assessment, and is maintaining its positive opinion of Glybera, Reuters reports. Background Glybera is the first gene therapy approved for use in the E...