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    Recon: Russia’s Sputnik V vaccine appears to be 92% effective; Novavax seeks authorization in Canada

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Biden administration to begin shipping vaccine doses directly to pharmacies ( Politico ) Biden Covid adviser tells providers to stop stockpiling vaccine ( Politico ) Pfizer expects $15bn in Covid vaccine revenue this year ( FT ) ( Endpoints ) Pfizer reports Q4 and full-year results ( Press ) Pfizer plans to deliver 200 million doses of Covid vaccine to US by ...
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    Recon: US to buy 8.5M Ellume at-home COVID tests; Bayer to produce CureVac vaccine

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Biden administration readies battle plan as Covid variants reach the U.S. ( Politico ) Moderna asks FDA to OK 5 additional doses per Covid vaccine vial ( CNBC ) ( Reuters ) US distributes 49.9M doses of COVID-19 vaccines, administers 31.1M shots ( Reuters ) Novavax expects to produce 150 million vaccine doses per month as early as May: CEO ( Reuters ) Trump o...
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    Recon: J&J, Novavax COVID vaccine readouts; FDA delays decision on Biogen’s Alzheimer’s drug

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA extends review period for Biogen's Alzheimer's drug to June ( Reuters ) ( WSJ ) ( STAT ) J&J adds to COVID-19 vaccine armoury with 66% efficacy in global trial ( Reuters ) ( STAT ) ( NYTimes ) J&J Covid Vaccine Supply to Start at 2 Million Doses, GAO Says ( Bloomberg ) US COVID vaccine hopeful using Gates Foundation cash to prepare for human trial ( Reuter...
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    Recon: Opioid groups campaign against Woodcock as FDA commissioner; EU warns it could block vaccine exports

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Advocacy groups urge Biden administration not to tap Woodcock as FDA commissioner ( STAT ) ( Endpoints ) Pharma distributors in talks with US for cut of COVID-19 vaccine shipping deal ( Reuters ) Pandemic spurs quest to enroll more Black Americans in vaccine trials ( Reuters ) COVID-19: Critical Vaccine Distribution, Supply Chain, Program Integrity, and Other ...
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    Recon: Biden administration to order 200M more COVID vaccine doses; AstraZeneca, EU spar over vaccine supplies

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Biden administration to buy 200 million more doses of Covid vaccine ( Politico ) U.S. CDC sees lower rates of allergic reaction after Pfizer vaccine ( Reuters ) Moderna in talks with US to sell 100 million more COVID-19 vaccine doses ( Reuters ) Eli Lilly, Regeneron's COVID-19 treatments may be weaker against South Africa variant ( Reuters ) Remdesivir, Given...
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    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 ...
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    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...
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    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...
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    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...
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    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...
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    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...
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    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...