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  • ReconRecon

    Recon: Biogen wants dialogue with CMS over Aduhelm coverage decision; GSK, Vir seek authorization for COVID antibody shot

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Senate Panel OKs Califf Nomination for FDA Chief ( NYT ) ( Inside Health Policy ) US Supreme Court blocks Biden vaccine-or-test policy for large businesses ( Reuters ) ( STAT ) GSK, Vir seek US approval for COVID-19 antibody therapy as shot in arm ( Reuters ) FDA concerns at contractor Catalent site spurred on shortages of Novo Nordisk's semaglutide — report (...
  • ReconRecon

    Recon: CMS to restrict coverage of Aduhelm to only clinical trials; FDA warns of dental issues with buprenorphine

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Criticized by Senators, US Health Officials Defend Omicron Response ( NYTimes ) ( Endpoints ) Omnicron will infect ‘just about everybody,’ Fauci says ( Washington Post ) FDA flags risk of dental issues from use of opioid addiction drug buprenorphine ( Reuters ) ( FDA ) CMS to restrict coverage of Biogen’s controversial Alzheimer’s drug to only clinical trials ...
  • ReconRecon

    Recon: Pfizer to cut sales staff as provider meetings move virtual; US buys 600k more doses of GSK-Vir COVID therapy

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US US FDA Advisory Committees: Flipping FDAA Mandate on its Head ( Pink Sheet ) Pfizer to cut US sales staff as meetings with healthcare providers move to virtual ( Reuters ) CDC eyes recommending higher quality masks: report ( The Hill) Future of Biogen’s Aduhelm hinges on Medicare Alzheimer’s coverage ( Reuters ) Recall report: Another month, another issue wi...
  • ReconRecon

    Recon: Bristol Myers buoys cell therapy interests with $3B Century deal; EMA could issue decision on Paxlovid within weeks

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Pfizer CEO unsure on need for fourth dose of COVID-19 vaccine ( Reuters ) Pfizer to pay Beam $300 million in gene-editing deal, amping up its mRNA ambitions ( STAT ) US breaks COVID-19 hospitalization record at over 132,000 as Omicron surges (Reuters) Starting later this week, some at-risk Americans become eligible for a 4th shot ( NYT ) FDA removes clinica...
  • ReconRecon

    Recon: CDC recommends Pfizer booster for 12- to 15-year-olds; Stryker to buy Vocera for nearly $3B

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US CDC recommends Pfizer's COVID-19 booster for ages 12 to 15 ( Reuters ) ( NYT ) Lifesaving Covid Treatments Face Rationing as Virus Surges Again ( NYTimes ) All vaccinated participants with severe COVID-19 in CDC study had at least one risk factor ( The Hill) Biden, in Shift Prepares Americans to See Covid-19 as Part of Life ( WSJ ) Containing Covid-19 requir...
  • ReconRecon

    Recon: Pfizer, BioNTech to develop mRNA shingles shot; French court backs class action over Sanofi’s Depakine drug

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA pauses domestic drug inspections again, this time to protect against Omicron ( Endpoints ) ( Fierce ) FDA Nominee’s Committee Vote Set ( Politico) Third former GSK scientist pleads guilty to conspiring to steal trade secrets ( Endpoints ) Why the conviction of Elizabeth Holmes hinged on defrauding Theranos investors, not patients ( STAT ) US Biosimilar A...
  • ReconRecon

    Recon: Elizabeth Holmes found guilty of four counts of fraud; Another big Paxlovid deal

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US More than 1 million Americans were diagnosed with COVID over the long holiday weekend ( NPR ) ( Reuters ) Elizabeth Holmes is found guilty of four counts of fraud ( NYT ) ( POLITICO ) The Epic Rise and Fall of Elizabeth Holmes ( NYT ) Pfizer carries pandemic momentum into 2022, scoring another huge Paxlovid deal with the US ( Fierce ) CDER, CBER Approve Total...
  • ReconRecon

    Recon: FDA clears Pfizer booster for 12- to 15-year-olds; Teva found liable in New York opioid trial

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US The FDA clears booster shots for 12- to 15-year olds ( NYTimes ) ( STAT ) ( Reuters ) ( WashingtonPost ) FDA authorizes new Merck Covid-19 pill despite scientists' concerns on its mechanism of action ( Endpoints ) FDA authorizes the first at-home pills from Pfizer to treat Covid-19 ( Endpoints ) Interval between Moderna COVID-19 vaccine second shot and booster...
  • ReconRecon

    Recon: EU states can offer early access to Pfizer’s COVID pill; Biogen to submit final designs for Aduhelm postmarketing study in March

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Biogen plans to submit final design of Aduhelm confirmatory trial to FDA in March ( Reuters ) As Aduhelm faces doubts, Biogen plans another pivotal trial for 2022 ( STAT ) Uncoordinated and redundant: FDA's Pazdur slams checkpoint inhibitor developers for creating a 'Wild West’ ( Endpoints ) A C.D.C. panel is meeting on a blood clot risk linked to J.&J.’s vacc...
  • ReconRecon

    Recon: EMA backs J&J booster; Califf on track for confirmation with GOP support

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Manchin, Sanders will oppose Biden FDA nominee Califf ( The Hill ) Biden’s FDA pick on track for confirmation with GOP help ( Politico ) Bristol Myers drug wins first U.S. approval for Graft versus Host Disease prevention ( Reuters ) ( FDA ) HHS secretary hints that more federal funds may be needed to fight an Omicron surge. ( NYTimes ) Opioid Makers Cement C...
  • ReconRecon

    Recon: Pfizer to buy Arena for $6.7B; Novartis sees strong interest in Sandoz unit

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Pfizer bets on Arena's promising bowel disease treatment in $6.7 bln deal ( Reuters ) A year after first U.S. shots, pandemic hallmarks re-emerge ( Reuters ) Out of Control: America’s losing battle against diabetes ( Reuters ) Drugmakers aim big price hikes at U.S. patients, congressional report finds ( Reuters ) ( STAT ) ( Politico ) Moderna's flu data offer...
  • ReconRecon

    Recon: FDA authorizes Pfizer booster for 16 and 17 year olds; China approves Brii Biosciences’ COVID antibody

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA expands authorization for Pfizer’s Covid-19 booster to cover 16- and 17-year-olds ( STAT ) ( FDA ) AstraZeneca Covid-19 Antibody Authorized by FDA as Novel Tool to Prevent Symptomatic Disease ( WSJ ) ( NYTimes ) ( FDA ) U.S. campaign to vaccinate young children off to sluggish start despite abundant supply ( Reuters ) Becerra names incoming acting NIH dire...