• ReconRecon

    Recon: Pfizer working on COVID vaccine booster; J&J expects data on its COVID vaccine next week

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Biden sets sights on 1.5 million vaccinations a day ( Politico ) Pfizer working on booster shot to protect against COVID-19 variants: Bloomberg ( Reuters ) Pfizer to Deliver US Vaccine Doses Faster Than Expected ( Bloomberg ) Johnson & Johnson expects details on COVID-19 vaccine trial next week ( Reuters ) ( CNBC ) FTC sues drug makers over allegedly illegal ...
  • ReconRecon

    Recon: Merck stops development of COVID vaccines; Moderna developing booster against new COVID variants

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Merck ends COVID vaccine program, cites inferior immune responses ( Reuters ) ( Endpoints ) ( STAT ) Pfizer Will Ship Fewer Vaccine Vials to Account for ‘Extra’ Doses ( NYTimes ) ( Politico ) US goal to squeeze more COVID shots from Pfizer vials hampered by syringe production ( Reuters ) Moderna says it believes vaccine will work against new variants ( Reuters...
  • TrackersTrackers

    COVID-19 therapeutics tracker

    Months into the COVID-19 pandemic, just three therapeutics have been approved to treat COVID-19: dexamethasone in the  United Kingdom  and  Japan ; Avigan (favilavir) in  China , Italy and Russia; and Veklury (remdesivir) in the United States ,  Japan  and Australia.   Three therapeutics have received emergency use authorizations (EUAs) in the US. Convalescent plasma, which was authorized by the Food and Drug Administration (FDA) on 23 August and is subject to updated...
  • TrackersTrackers

    COVID-19 vaccine tracker

    The worldwide endeavor to create a safe and effective COVID-19 vaccine is bearing fruit. A handful of vaccines now have been authorized around the globe; many more remain in development.   To clarify the landscape for our readers, our vaccine tracker now has been split in two. The first chart details vaccines that have achieved regulatory authorization or approval; the second continues to follow candidates in Phase 1-3 clinical trials and some promising candidates in e...
  • ReconRecon

    Recon: Lilly says antibody drug prevented COVID in nursing home study; Biden to invoke Defense Production Act

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Biden leaves top FDA job open amid vaccine push ( Politico ) Lilly Antibody Drug Prevents Covid-19 in Nursing Homes, Study Finds ( WSJ ) ( STAT ) U.S., staying in WHO, to join COVID vaccine push for poor nations: Fauci ( Reuters ) California resumes Moderna COVID-19 vaccine usage after pause ( Reuters ) Biden dissolves Covid-19 panel that advised his transiti...
  • ReconRecon

    Recon: WHO says three COVID vaccines in final review for EUL; Hahn’s exit interviews

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Outgoing FDA chief: The agency fought 'substantial' pressure under Trump ( Politico ) Trump FDA Chief Was 'Disgusted' by Riots, Stayed to Guide Agency: Q&A ( Bloomberg ) “A Tsunami of Randoms”: How Trump’s COVID Chaos Drowned the FDA in Junk Science ( Vanity Fair ) Janet Woodcock to Lead FDA on Interim Basis ( WSJ ) Biden to hit reset on nation's fight agains...
  • ReconRecon

    Recon: Independent review critical of delayed pandemic response; US Supreme Court rejects Merck hep C patent appeal

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Small biotech launches human trials of a potential ‘backstop’ for Covid-19 vaccines ( STAT ) Will the FTC get tougher on pharma business practices under the Biden administration? ( STAT ) Supreme Court rebuffs Merck appeal in hepatitis C patent fight with Gilead ( Reuters ) ( Law360 ) Mylan loses bid to dismiss EpiPen antitrust claims ( Reuters ) How Operatio...
  • ReconRecon

    Recon: FDA approves Daiichi’s Enhertu for certain gastric adenocarcinomas; Norway says advice on Pfizer vaccine unchanged

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US AstraZeneca, Daiichi's breast cancer drug gets broader US approval ( Reuters ) ( FDA ) Biden will keep Dr. Francis Collins as National Institutes of Health director: statement ( Reuters ) Biden warns of challenges ahead as he rolls out new vaccine plan ( Politico ) Biden Administration Will Rename 'Operation Warp Speed,' Citing Trump 'Failures’ ( NPR ) ( Polit...
  • ReconRecon

    Recon: Trump admin eyes term limits on top health jobs; Pfizer temporarily reduces vaccine shipments

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Vaccine reserve was already exhausted when Trum administration vowed to release it ( Washington Post ) Trump admin races to enact term limits for top health scientists ( Politico ) Trump wants billions cut from global Covid vaccine distributor ( Politico ) Former FDA commissioner: "Reliable drug supply is absolutely critical" ( Axios ) Biden taps D.C. veteran...
  • ReconRecon

    Recon: Woodcock expected as acting FDA commissioner; J&J vaccine induces immune response in early trial

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Woodcock to serve as acting FDA commissioner, Sharfstein a contender for top FDA job ( BioCentury ) ( Endpoints ) ( Bloomberg ) Biden’s Covid board in the dark on final vaccine plan ( Politico ) Data fuel debate over whether J&J’s one-dose Covid vaccine will measure up ( STAT ) ( Bloomberg ) ( NEJM ) J&J vaccine on track for March rollout with target to delive...
  • ReconRecon

    Recon: US buys 1.25M more doses of Regeneron COVID antibody drug; Sinovac defends vaccine after latest Brazilian data

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA fights for independence in Trump administration's final days ( Politico ) Johnson & Johnson Expects Vaccine Results Soon but Lags in Production ( NYTimes ) Supreme Court Revives Abortion-Pill Restriction ( NYTimes ) Operation Warp Speed chief resigns at Biden team’s request, will stay through transition, sources say ( CNBC ) US to buy 1.25M additional dos...
  • ReconRecon

    Recon: US overhauls vaccine rollout plans; Novartis, BeiGene partner on tislelizumab

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US HHS 'unleashed' in string of last-minute policies ( Politico ) In a last-minute, intra-agency scuffle, HHS overrules FDA pick for a key position ( STAT ) ( Politico ) Pfizer has produced more than 70 million COVID-19 vaccine doses: CEO ( Reuters ) US shifts to speed vaccinations; won’t hold back 2nd doses ( AP ) ( Reuters ) ( Bloomberg ) Democrats demand plan...