• ReconRecon

    Recon: Lilly to seek accelerated approval for its Alzheimer’s drug; FDA to add warning about rare heart inflammation to Pfizer, Moderna vaccines

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Biogen working to speed up confirmatory study for approved Alzheimer's drug ( Reuters ) Biogen opens door to adjusting price of Alzheimer's drug amid outcry ( The Hill ) Lilly to seek accelerated FDA approval for Alzheimer's drug this year ( Reuters ) ( STAT ) ( Press ) Op-Ed: Here’s why we approved the 1st new Alzheimer’s drug in 2 decades ( WaPo ) ( STAT ) ...
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    Recon: WHO cites concerns about Sputnik V plant; GSK’s drug arm to get $11B windfall from consumer spin-off

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA documents show struggle over approval of new Alzheimer's drug from Biogen ( Reuters ) ( WSJ ) ( Boston Globe ) ( STAT ) ( Politico ) Woodcock defends Biogen's new Alzheimer's drug, says it has more supportive data than many past accelerated approvals ( Endpoints ) Powerful Democrat’s new drug pricing manifesto hints at a carveout for small biotechs ( STAT )...
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    Recon: EMA signs off on two more Pfizer/BioNTech manufacturing sites; EU to extend vaccine export controls through September

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US New Drug Could Cost the Government as Much as It Spends on NASA ( NYTimes ) Biden administration likely to miss Independence Day vaccination target ( Politico ) Pear Therapeutics to go public in $1.6 billion SPAC merger ( STAT ) ( Endpoints ) FDA Approves First Oral Anticoagulant for Children ( Medscape ) ( FDA ) Blackstone to invest $250M in cell therapy sta...
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    Recon: Supreme Court rebuffs Amarin, Abbvie in separate rulings; Moderna to ramp up vaccine production

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Supreme Court rebuffs insurers on Obamacare reimbursements ( Reuters ) Supreme Court denies Amarin's bid to revive Vascepa drug patents ( Reuters ) Supreme Court rebuffs AbbVie appeal in patent fight involving AndroGel drug ( Reuters ) ( Law360 ) Moderna plans to expand COVID-19 vaccine production ( Reuters ) ( WSJ ) HHS backs down in legal fight over drug di...
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    Recon: Sen. Manchin opposes Woodcock for FDA Commissioner; BMS, Eisai in $3.1B cancer drug development deal

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Sen. Manchin to Biden: Don't nominate Woodcock for FDA commissioner ( Endpoints ) ( The Hill ) ( Letter ) Over 300 cases of heart issue after Covid vaccination reported in young people, CDC says ( NBC ) White House to finish allocating 80 mln U.S.-made COVID-19 shots for shipment abroad ( Reuters ) Analysis: Rival treatments may help justify FDA gamble with Bi...
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    Recon: Becerra signals more time needed to nominate FDA chief; CureVac vaccine disappoints in pivotal trial

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US More Time Needed on FDA Pick, Becerra Says ( Bloomberg ) ( Endpoints ) US Supreme Court rejects Republican challenge to Obamacare law ( Reuters ) ( KHN ) ( NYTimes ) Vaccine Maker Earned Record Profits but Delivered Disappointment in Return ( NYTimes ) ACIP readies Friday meeting on vaccine safety, boosters ( Politico ) Blueprint Medicines nabs 4th approval i...
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    Recon: US buys another 200M doses of Moderna vaccine; First patient receives Biogen Alzheimer's drug

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US US buys 200 mln more Moderna COVID-19 vaccine doses ( Reuters ) First patient receives controversial Biogen Alzheimer's drug ( Reuters ) Regeneron’s antibody therapy cuts deaths among some hospitalised COVID-19 patients -study ( Reuters ) ( STAT ) US authorizes another 14 mln doses of Johnson & Johnson's COVID-19 vaccine -sources ( Reuters ) Lawmakers revive ...
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    Recon: AZ antibody cocktail fails to prevent COVID symptoms in large trial; Former FDA Commissioner Hahn ventures on to Flagship

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Novavax says efficacy preserved in participants receiving influenza, COVID-19 vaccines ( Reuters ) Trump’s FDA commissioner takes job at Moderna backer ( Washington Post ) ( Endpoints ) Divisive Drug Patent Proposal From Trump Era Is on Biden Agenda ( Bloomberg ) ( Law360 ) Sage's depression drug study results show improvement in symptoms ( Reuters ) ( STAT ) ...
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    Recon: Novavax COVID-19 vax 90%-plus effective; GSK pays big for Iteos' TIGIT-targeted immunotherapy

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Novavax Offers U.S. a Fourth Strong Covid-19 Vaccine ( NYT ) ( NPR ) ( Reuters ) Another Sad Coronavirus Pandemic Milestone Is Approaching ( NPR ) U.S. Not On Pace To Meet Biden's Vaccination Goal ( NPR ) Eight states see rise in new COVID-19 infections ( The Hill ) U.S. has administered over 309 million doses of Covid-19 vaccines, CDC says ( CNBC ) How did ...
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    Recon: FDA asked J&J to discard 60M vaccine doses made at Emergent plant; EMA adds rare blood condition as side effect of AZ shot

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA tells J&J that 60M doses made at Emergent plant cannot be used ( NYTimes ) ( Reuters ) ( Politico ) J&J vaccine doses to be released, but many will be tossed ( AP ) ( Axios ) ( FDA ) FDA faces mounting criticism over Alzheimer’s drug approval ( Reuters ) Eli Lilly memo says firm did not make false statements to FDA ( Reuters ) Controversial drug approval ...
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    Recon: FDA extends shelf life of J&J vaccine; Ocugen to seek BLA for its COVID vaccine

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US US to donate 500 million Pfizer doses to poor nations ( Reuters ) ( Politico ) US is in discussions with Moderna on buying Covid vaccine doses for other nations ( CNBC ) Moderna files for US authorization to use its COVID-19 vaccine in teens ( Reuters ) ( NYTimes ) FDA extends shelf life of Johnson & Johnson COVID-19 vaccine ( Reuters ) Ocugen to file for ful...
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    Recon: US signs for $1.7M courses of Merck’s experimental COVID drug; FDA approves Vertex CF drug for 6-11 year olds

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Biden says he will be announcing a vaccine plan for the world ( Reuters ) White House urges states to seek longer shelf life for J&J shots as millions near expiration ( Reuters ) ( KHN ) ( Politico ) US signs $1.2 bln deal for 1.7 mln courses of Merck's experimental COVID-19 drug ( Reuters ) ( HHS ) Vertex cystic fibrosis treatment gets U.S. approval for use i...