• 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...
  • ReconRecon

    Recon: Pfizer to buy 8.1% stake in Valneva, Merck explores Seagen buyout

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US COVID vaccine rollout for US children close after CDC panel vote ( Reuters ) Lawmakers ask GAO to probe pharmacy benefit managers over their role in drug pricing ( STAT ) Comparing the Pfizer and Moderna Covid vaccines for young children ( STAT ) Merck Explores Purchase of Biotech Seagen ( WSJ ) FDA advisors mostly agree that Acadia’s Nuplazid isn't effective...
  • ReconRecon

    Recon: EMA starts rolling review of Pfizer-BioNTech variant vaccine; Pfizer halts Paxlovid study enrollment for lower-risk population

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA Advisers Review Pfizer, Moderna Covid-19 Vaccines in Young Children ( WSJ ) ( STAT ) ( Reuters ) US pivots to ‘harm reduction’ after 107,000 overdose deaths last year ( FT ) Briefing docs for Acadia's Alzheimer's-related psychosis resubmission reveal an undecided FDA ( Endpoints ) Bristol Myers asks Supreme Court to revive $1.2 bln cancer-drug patent win (...