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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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    FDA says it far exceeded its projections for inspections in FY2021

    In an update to its Resiliency Roadmap for FDA Inspectional Oversight , the US Food and Drug Administration (FDA) on Monday said that the number of domestic surveillance inspections it carried out in the second half of FY2021 was more than double the number it initially projected in the roadmap last spring.   In its initial Roadmap, FDA estimated that more than 15,000 domestic surveillance inspections that it planned to complete in FY2020 and FY2021 were postponed due...
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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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    This Week at FDA: mRNA boosters for most; Blood lancets reclassified

    Welcome to our weekly digest of regulatory news from the US Food and Drug Administration (FDA), legislative updates, and other news updates we think you’ll find useful — and interesting. This week saw COVID-19 vaccine and therapy updates, the unveiling of Cures 2.0 , and lots of device updates. As usual, we welcome feedback at news@raps.org .    Friday morning, the US Food and Drug Administration (FDA) announced an expansion of the emergency use authorizations (EUA...
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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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    Long-awaited Cures 2.0 bill unveiled

    Two years after beginning work on a follow up to the 21 st Century Cures Act , Reps. Fred Upton (R-MI) and Diana DeGette (D-CO) on Tuesday introduced their Cures 2.0 bill.   The 173-page bill, intended to supercharge medical innovation, would provide new funding for programs at the US Food and Drug Administration (FDA) and Centers for Medicare and Medicaid services (CMS), as well as create the $6.5 billion Advanced Research Projects Agency for Health (ARPA-H). A co...
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    Asia-Pacific Roundup: TGA posts guidance on transition to device reclassification after consultation confusion

    Australia’s Therapeutic Goods Administration (TGA) has published guidance on the transitional arrangements for the reclassification of certain medical devices. The guidance follows a consultation that exposed the urgent need for clarification of the classification rule and definitions.   TGA’s guidance applies to medical devices that are substances introduced into the human body via a body orifice or applied to the skin. As TGA explains in the document, that definition...
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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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    FDA revises COVID test approach after HHS reverses Trump-era LDT directive

    The US Food and Drug Administration (FDA) on Monday revised its guidance on COVID-19 tests during the public health emergency after the Department of Health and Human Services (HHS) withdrew a Trump-era policy that restricted FDA from requiring premarket review for laboratory developed tests (LDTs).   Under the updated policy, FDA said it generally expects that newly offered COVID-19 tests will have an emergency use authorization (EUA) or traditional marketing authoriz...
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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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    Biden nominates Califf as FDA commissioner

    After months of speculation – and just days before a statutory deadline – President Joe Biden on Friday announced he would nominate Robert Califf to serve as Commissioner of Food and Drugs for the second time.   "I am confident Dr. Califf will ensure that the FDA continues its science and data driven decision-making. Dr. Califf had strong bipartisan support in the Senate in 2016, and I urge the Senate to swiftly confirm Dr. Califf so he can continue the important work ...