• ReconRecon

    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...
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    Recon: Pfizer to start large pediatric trial of COVID-19 vaccine; FDA pushes back decision on Incyte’s Jakafi

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Pfizer to start large study to test COVID-19 vaccine in children below 12 ( Reuters ) Inovio expands partnership with Advaccine for COVID-19 vaccine study ( Reuters ) Incyte the latest to fall victim to JAK scrutiny as FDA pushes back Jakafi review in GVHD ( Fierce ) FDA rejects Google's push to add virtual exam for Parkinson’s disease to its smartwatch ( Endp...
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    Recon: Biogen wins accelerated approval for aducanumab; FDA lifts hold on bluebird bio gene therapy trial

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA Approves Alzheimer’s Drug Despite Fierce Debate Over Whether It Works ( NYTimes ) ( Politico ) ( STAT ) ( FDA 1 , 2 ) Why Biogen may be sitting on the most lucrative product in pharmaceutical history ( STAT ) FDA approves drug to treat smallpox ( FDA ) J&J vaccine drive stalls out in US after safety pause ( Reuters ) FDA approves Novo Nordisk's semagluti...
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    Recon: UK authorizes Pfizer-BioNTech vaccine for adolescents ages 12-15; News from ASCO

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US US authorizes lower dose of Regeneron's COVID-19 antibody therapy ( Reuters ) ( Endpoints ) Investors, patients await FDA decision on Biogen Alzheimer's drug due Monday ( Reuters ) Biden health official 'taking a look' at Trump drug pricing proposal ( The Hill ) First US Vaccine Donations Will Go to ‘Wide Range’ of Nations in Need ( NYTimes ) For first time, ...
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    Recon: Senate finance chair probes AbbVie over corporate tax strategy; Abernethy goes to Verily to head clinical research

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Biden admin probes risk of low-level contamination in vaccines made at troubled plant ( Politico ) Ejected from a troubled plant, AstraZeneca is in talks about producing vaccine for US government at another site. ( NYTimes ) ( Reuters ) Lawsuit says Bristol-Myers avoided $6.4 bln payment by delaying cancer drug ( Reuters ) As FDA decides on Biogen drug for Alz...
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    Recon: Morphosys to buy Constellation Pharma in $1.7B deal; US begins study to mix-and-match COVID vaccine boosters

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US US to detail global distribution plan for 80M vaccine doses ( Reuters ) US begins study testing mix-and-match Covid vaccine booster shots ( CNBC ) Moderna bags another US CDMO to help with fill-finish work for its vaccine amid booster push ( Endpoints ) Moderna plans mix of COVID-19 vaccine doses with new Lonza deal ( Reuters ) AbbVie's Skyrizi takes home a w...
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    Recon: Moderna submits BLA for COVID vaccine; FDA approves Alkermes’ schizophrenia drug

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Supreme Court rebuffs J&J appeal over $2 billion baby powder judgment ( Reuters ) Moderna files for full US approval of COVID-19 vaccine ( Reuters ) ( NYTimes ) Alkermes schizophrenia drug gets FDA approval ( Reuters ) ( Endpoints ) BridgeBio keeps FDA approval spree rolling, this time with nod for targeted bile duct cancer med ( Fierce ) US agency says emplo...
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    Recon: FDA approves Amgen’s KRAS-blocking lung cancer drug; EMA recommends Pfizer-BioNTech vaccine for children ages 12-15

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US A $6 trillion budget lays out Biden's vision, but Republicans unlikely to be swayed ( Reuters ) ( Politico ) Boxed in: How a single Pfizer decision complicated the Covid vaccine rollout while boosting profits ( STAT ) Amgen wins FDA approval for first KRAS-blocking lung cancer drug ( STAT ) ( FDA ) US FDA approves Bristol Myers' bowel disease treatment ( Reute...
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    Recon: Lilly receives subpoena over COVID drug manufacturing site; FDA grants EUA for GSK-Vir antibody drug

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Eli Lilly receives DoJ subpoena over COVID-19 drug manufacturing plant ( Reuters ) ( Endpoints ) US FDA gives emergency use approval for GSK-Vir COVID-19 antibody drug ( Reuters ) ( FDA ) US pauses use of Eli Lilly Covid-19 mAb combo in six more states due to variants from Brazil, India ( Endpoints ) FDA adds new 'do not use' note to Intercept's Ocaliva label ...
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    Recon: BMS’ Opdivo wins full FDA approval for resected esophageal or GEJ cancer; Japan authorizes Moderna, AZ COVID vaccines

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Full OK for Covid Shots Will Take Months, FDA Vaccine Chief Says ( Bloomberg ) FDA Approves First Targeted Therapy for Subset of Non-Small Cell Lung Cancer ( FDA ) FDA recommends not using syringes from Chinese firm after safety issues with vaccine injections ( Reuters ) ( FDA ) BMS’ Opdivo wins FDA approval for resected esophageal or GEJ cancer ( Endpoints ) ...