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  • ReconRecon

    Recon: EMA starts rolling review of Valneva’s COVID vaccine; Biden eyes free at-home tests to curb Omicron

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US GSK says tests indicate antibody drug works against Omicron ( Reuters ) ( WSJ ) To fight Omicron, Biden to add travel rules, make at-home COVID tests free ( Reuters ) ( STAT ) Special Report: US rushed contracts to COVID-19 suppliers with troubled plants ( Reuters ) AstraZeneca to Scrap Plan for US Covid Booster Study ( Bloomberg ) BD enters varicose vein tre...
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    Recon: FDA advisors narrowly back Merck’s COVID drug; Sanofi to buy Origimm for its acne vaccine candidate

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA advisers narrowly endorse Merck's Covid-19 drug ( Politico ) ( NYTimes ) ( STAT ) FDA finds 'low likelihood' omicron will impact COVID-19 PCR, antigen tests ( MedtechDive ) Testing labs brace for first U.S. cases of Omicron ( Politico ) Prosecutors Push Elizabeth Holmes of Theranos to Take Responsibility ( NYTimes ) ( CNBC ) 23andMe Earmarks Cash From SPA...
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    Recon: FDA panel to weigh in on Merck’s COVID antiviral pill; Aspen signs deal for J&J COVID vaccine

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA Actively Working to Investigate, Address Potential Impacts of Omicron Variant; Urges Vaccination and Boosters ( FDA ) U.S. FDA panel to weigh Merck's COVID-19 antiviral drug ( Reuters ) ( NYTimes ) ( NPR ) Biden says he will direct FDA, CDC to use ‘fastest process available’ to clear Covid vaccines targeting omicron ( CNBC ) Merck says its COVID-19 drug sh...
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    Recon: Blueprint's $250M preclinical buy; WHO, CDC, Biden react to Omicron variant

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Biden says omicron variant is cause for concern but not panic ( NPR ) CDC Statement on B.1.1.529 (Omicron variant) ( CDC ) Pfizer boosts Paxlovid manufacturing capacity as Merck’s rival COVID pill hits surprise efficacy setback ( Fierce ) Opinion: Becerra needs to open up to the press ( AHCJ ) Opinion: Will Moderna Ever Learn to Share? ( MedPage Today ) Who ...
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    Recon: Califf nomination timeline slips after Biden admin misses paperwork deadline; Canada fully approves J&J COVID vaccine

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA nomination slips after Biden admin fails to send papers to Congress ( Politico ) Califf, Biden’s pick to lead FDA, has millions invested in pharma and tech companies ( STAT ) FDA Approves Takeda's drug for post-transplant CMV infection ( Reuters ) ( FDA ) CVS, Walgreens and Walmart Fueled Opioid Crisis, Jury Finds ( NYTimes ) Elizabeth Holmes Points Finge...
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    Recon: Global license deal to provide COVID antibody test tech free to poorer countries; GSK partners with Arrowhead for NASH drug

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Elizabeth Holmes’ defense lets Theranos founder play role of young do-gooder in second day on stand ( CNBC ) ( Law360 ) Holmes to take stand for third day in Theranos fraud trial ( Reuters ) Why You Can’t Find Cheap At-Home Covid Tests ( KHN ) GSK dives into NASH, RNA interference with Arrowhead deal ( BioPharmaDive ) Califf’s profitable industry ties spark f...
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    Recon: Pfizer touts long-term efficacy data for COVID vaccine in adolescents; House panel seeks interview with Hahn

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US CDC expands eligibility for Covid-19 booster shots to all adults ( STAT ) Johnson & Johnson touts ‘golden moment’ to pursue pharma-led future ( FT ) Concerns Grow Over Safety of Aduhelm After Death of Patient Who Got the Drug ( NYTimes ) Bluebird, after delays, gets speedy FDA review for beta thalassemia gene therapy ( BioPharmaDive ) CBO: Democrats' package ...
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    Recon: Novo Nordisk to buy Dicerna for $3.3B; US signs deal for $5.3B worth of Pfizer's COVID antiviral drug

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA approves Merck's Keytruda as first immunotherapy for early kidney cancer ( BioPharmaDive ) ( FDA ) Pfizer signs $5.3 billion U.S. deal to supply COVID-19 antiviral pills ( Reuters ) J&J sees potential for 14 new multibillion-dollar drugs by 2025 ( Reuters ) White House Plans Major Expansion of Covid Vaccine Production ( NYTimes ) Gilead pays up to retain ...
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    Recon: Biogen's Alzheimer's drug gets negative trend vote from EMA panel; EMA says Novavax authorization could come 'within weeks'

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA Plans to Authorize Pfizer Boosters for All Adults This Week ( NYTimes ) Watchdog group calls on FDA to disqualify Hennepin Healthcare doctors, review board from clinical research ( StarTribune ) U.S. plans to invest billions in manufacturing COVID-19 vaccine ( Reuters ) ( Politico ) Pfizer CFO D'Amelio to retire after 15 years at company ( Reuters ) U.S. ...
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    Recon: Pfizer to allow generic versions of its COVID drug in 95 countries; Moderna, EU sign deal to donate 70M vaccine doses

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Pfizer asks FDA to authorize COVID-19 pill for unvaccinated people ( NYTimes ) As Big Pharma and Hospitals Battle Over Drug Discounts, Patients Miss Out on Millions in Benefits ( KHN ) Report says drugmakers impose unjustified U.S. price increases; spending on AbbVie drug rises $1.4 billion ( Reuters ) ( BioPharmaDive ) ( Fierce ) Pharmacy chains defend action...
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    Recon: Philips in talks with FDA after ventilator findings; Washington state seeks billions from opioid distributors

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Dems’ plan to limit drug price inflation faces test in Senate ( Politico ) Landmark opioid trial of 3 major pharmacy chains nears its end ( Reuters ) McKesson, drug distributors face $95 billion opioid trial in Washington state ( Reuters ) ( AP ) Philips in talks with FDA after new ventilator findings – statement ( Reuters ) FDA Approves Treatment for Rare Bl...
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    Recon: EMA recommends Regeneron, Celltrion antibodies; Ellume test recall expanded to 2M units

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Moderna COVID-19 vaccine patent dispute headed to court, U.S. NIH head says ( Reuters ) Moderna says Covid vaccine has fewer breakthrough cases than Pfizer’s, but higher myocarditis rates in young men ( CNBC ) The Core Legal Strategy Against Opioid Companies May Be Faltering ( NYTimes ) Home virus tests recalled over false positives reach 2 million kits. ( NYT...