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  • ReconRecon

    Recon: FDA approves Alnylam’s Oxlumo for PH1; EU secures 160M doses of Moderna vaccine

    In Focus: US Alnylam wins US approval for its third rare disease drug ( BioPharmaDive ) ( FDA ) Vaccinating a nation: can Biden manage America’s biggest health project? ( FT ) A Revamped Strategic National Stockpile Still Can't Match The Pandemic's Latest Surge ( NPR ) Amgen cuts Cytokinetics loose after heart drug disappointment ( BioPharmaDive ) A top Democrat on the House antitrust panel sets sights on Big Pharma after wrapping up tech probe ( CNBC ) PhRMA s...
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    Recon: Merck to buy OncoImmune for $425M; FDA approves first drug for Progeria

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US AstraZeneca to seek FDA authorization for vaccine based on foreign trial data ( Politico ) FDA approves first drug for rare disease that causes premature aging in children ( Boston Globe ) ( FDA ) FDA approves Xofluza for post-expousre prevention ( FDA ) US infectious disease group backs Gilead's remdesivir for COVID-19 treatment ( Reuters ) Trump unveils pla...
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    Recon: UK asks MHRA to review Pfizer COVID vaccine; Novartis signs deal for Mesoblast cell therapy

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Pfizer is first to apply for US emergency use for COVID-19 vaccine ( Reuters ) ( STAT ) 'We cannot rest': Despite promising Covid-19 vaccine results, trials must continue ( NBC ) Five US agencies have started telling employees they could get Covid vaccine shots in as little as 8 weeks ( CNBC ) Trump will announce on Friday rules to lower US drug prices ( Reute...
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    Recon: Pharma supply chain vulnerable during COVID; OIG takes aim at pharma speaker program

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Pfizer, Moderna Discussing When To Drop Controls In COVID Vaccine Trials With US Government ( Pink Sheet ) When will COVID-19 vaccines be widely available? Feds lay out an ambitious timeline ( Fierce Pharma ) FDA and FTC issue more warning letters citing products and services making illegal COVID claims ( Science-Based Medicine ) House OKs Bill To Join Global ...
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    Recon: Judge approves $8.3B Purdue settlement; Congo declares end of Ebola outbreak

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Pfizer To Seek FDA OK For COVID-19 Vaccine 'Within Days’ ( NPR ) ( NYTimes ) ( STAT ) ( Reuters ) ( CNN ) ( Press ) FDA said to plan early December advisory meetings to discuss Covid-19 vaccines ahead of potential authorization ( CNBC ) Pfizer says analysis shows 3.8% of participants experienced fatigue ( Reuters ) Americans Are More Willing to Take a Coronavi...
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    Recon: FDA delays decision on BMS’ liso-cel therapy; Amazon launches online pharmacy service

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA delays decision on Bristol Myers cancer therapy due to COVID-19 travel curbs ( Reuters ) ( Endpoints ) ( Press ) FDA rejects Alkermes schizophrenia drug, citing manufacturing concerns ( BioPharmaDive ) ( Endpoints ) Amazon launches online pharmacy in new contest with drug retail ( Reuters ) ( STAT ) US hospitals to restrict Lilly COVID-19 antibody treatmen...
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    Recon: Moderna says COVID vaccine more than 94% effective; Drugmakers offer C$1B to fend off new Canadian pricing rules

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Moderna says coronavirus vaccine more than 94 percent effective ( Politico ) ( STAT ) ( NYTimes ) J&J starts two-dose trial of its COVID-19 vaccine candidate ( Reuters 1 , 2 ) J&J supply chain exec: ‘I lose sleep’ over sending Covid-19 vaccine to lower-income countries ( STAT ) Azar says FDA will move ‘as quickly as possible’ to clear Moderna, Pfizer’s Covid ...
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    Recon: Swissmedic begins rolling review of Moderna COVID vaccine; COVAX raises $2B

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US US government partners with pharmacy chains to increase COVID-19 vaccine access ( Reuters ) An FDA adviser on why his panel took a skeptical view on Biogen’s Alzheimer’s drug ( STAT ) Indivior hit with $600 million in civil and criminal penalties over marketing of opioid addiction treatment ( The Hill ) ( DoJ ) Labs sound alarm on coronavirus testing capacity,...
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    Recon: AstraZeneca cancer drug disappoints in COVID trial; Lawmakers seek changes to $8.3B Purdue settlement

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Fauci stresses on need for equitable access of COVID-19 vaccines ( Reuters ) How Pfizer Plans to Distribute Its Vaccine (It’s Complicated) ( NYTimes ) Moderna close to revealing first data on whether its vaccine works ( Politico ) ( FT ) Pfizer says placebo patients will eventually get its Covid-19 vaccine. The question of when is complicated ( STAT ) Lawmake...
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    Recon: Russia claims Sputnik COVID vaccine is 92% effective; EU approves contract for Pfizer-BioNTech vaccine

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Moderna on track to report COVID-19 vaccine data later this month ( Reuters ) Cold storage challenges could hamper distribution of Pfizer, Moderna COVID-19 vaccines, Fauci says ( Reuters ) Health officials to begin distribution of Eli Lilly antibody drug this week ( The Hill ) For Eli Lilly’s newly authorized Covid-19 treatment, a dosing discrepancy causes con...
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    Recon: Sinovac vaccine trial halted in Brazil; Amgen, AstraZeneca asthma drug hits Phase 3 goals

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Asthma drug from Amgen, AstraZeneca achieves main goals in late-stage clinical trial ( STAT ) ( Endpoints ) Two conservative US Supreme Court justices suggest Obamacare may not be thrown out ( Reuters ) Health Secretary Azar says US has a plan to start Pfizer vaccine shots in December: CNBC ( Reuters ) Arcturus expects its COVID-19 vaccine to be ready by first...
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    Pfizer-BioNTech vaccine 90%-plus effective; Biden-Harris transition's COVID advisory board

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Biden-Harris Transition Announces COVID-19 Advisory Board ( Biden-Harris Transition ) ( CNN ) ( STAT ) ( NPR ) Biden’s ready to start his pandemic response immediately ( STAT ) As Nation Awaits Vaccine, Biden Is Under Pressure to Name New FDA Chief ASAP ( KHN ) ‘They’re not really doing anything’: As Covid-19 cases spiral, leaders around the U.S. lose urgency ...