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    Euro Convergence Day 3: AI's regulatory framework, the future of ATMPs, and more

    As Euro Convergence 2021 draws to a close, the European regulatory affairs community will gather virtually to hear updates on artificial intelligence and cell and gene therapies, and to explore how post-marketing surveillance will change in the upcoming years.   Use of artificial intelligence (AI) is seeping into more and more corners of healthcare, and those working in medical devices need to know how regulators address these technologies. Pat Baird, a senior regulato...
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    FDA tallies pandemic inspection toll, issues new 'resiliency roadmap'

    A new report from the US Food and Drug Administration details its performance on inspections during the public health emergency of the COVID-19 pandemic and details the agency’s roadmap going forward.   “The numbers reveal the state of our inspectional oversight and how we plan to address postponed inspectional work using a risk-based approach,” wrote acting FDA director Janet Woodcock, MD, in a forward to the Resiliency Roadmap for FDA Inspectional Oversight .   ...
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    Merck KGaA raises full-year forecast; Perlmutter's new gig tackles 'undruggable targets'

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Lilly hit by staff accusations, FDA scrutiny at COVID drug factories ( Reuters ) Pharma showers Menendez with rare, off-cycle burst of campaign cash as Democrats eye drug pricing reforms ( STAT ) Rising wholesale drug prices really do matter to half of all commercially insured Americans ( STAT ) Facing fresh pricing threats in D.C., pharma spent a record $92...
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    FDA adcomm declines to yank accelerated approvals for cancer immunotherapies

    At the halfway mark in its review of six “dangling” accelerated approvals for cancer immunotherapies, an advisory committee to the US Food and Drug Administration has declined to rescind approvals for any of the indications it has reviewed to date, citing immature data and ongoing unmet patient need.   FDA’s Oncologic Drugs Advisory Committee (ODAC), convening virtually, has thus far reviewed two indications for Genentech’s Tecentriq (azetolizumab) and one for Merck, S...
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    Time's up for questionable cell and tissue products, says Marks

    Purveyors of unapproved cellular-derived treatments are about to find out what happens when the US Food and Drug Administration ends its period of enforcement discretion for these regenerative medicine products.   A three-year clock for enforcement discretion began when FDA announced its regenerative medicine policy framework in November 2017; the COVID-19 pandemic prompted a 6-month extension, announced the agency last summer. Time is now up, and no more extensions ...
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    Recon: Vertex inks $900M deal with CRISPR Therapeutics; Congress investigates Emergent's contracts

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Is the US FDA at A Tipping Point? ( Pink Sheet ) New report finds COVID-19 pandemic causes dramatic shifts in prescription drug spending ( EurekAlert ) Trump administration awarded a firm $1.3 billion to make Covid vaccine syringes. Where are they? ( NBC ) U.S. Reaches Another Crucial Juncture In The Fight Against COVID-19 ( NPR ) Biden to push for more vacci...
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    Recon: Abbott profits triple with OTC test launch; Good news for bluebird

      Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Large clinical trial to study repurposed drugs to treat COVID-19 symptoms ( NIH ) Q&A with Acting FDA Commissioner Janet Woodcock on the Future of the FDA ( BioSpace ) Covid cases, vaccinations remain elevated as U.S. nears Biden’s 200 million goal ( CNBC ) U.S. CDC expands COVID-19 vaccine eligibility to 16 and older ( Reuters ) Johnson & Johnson reports...
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    Rare diseases, STAR expansion considered in PDUFA VII premarket negotiations

    Newly released minutes from meetings between industry and the US Food and Drug Administration (FDA) give observers more insight into premarket review issues in play during the negotiations for the reauthorization of the Prescription Drug User Fee Act (PDUFA VII).   FDA and industry looked at commitment language related to new molecular entity (NME) milestones and postmarketing requirements (PMR) in a 27 January meeting of the premarket negotiations subgroup. For both s...
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    Recon: ThermoFisher acquires PPD for $17.4B; First chimeric human-monkey embryos

      Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Daily U.S. Covid cases remain above 70,000 amid Johnson & Johnson vaccine pause ( CNBC ) Fauci, Jim Jordan spar over pandemic restrictions ( The Hill ) What’s behind the wait on a J&J vaccine verdict ( Politico ) ( NYT ) ( WSJ ) The J&J Vaccine Pause Is Science Working Like It’s Supposed To ( Slate ) Why the Johnson & Johnson pause may not matter for Amer...
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    FDA, CDC recommend J&J vaccine pause while rare clots investigated

    In a joint statement followed by a Tuesday morning press conference, the US Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) have recommended that administration of the one-dose Johnson & Johnson COVID-19 vaccine be paused.   The recommendation follows reports of six US cases of women between the ages of 18 and 48 years who received the vaccine and then experienced cerebral venous sinus thrombosis (CVST) – a blood clot in a larg...
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    Insurance, physician barriers impede wider adoption of biosimilars

    Since 2015, the US Food and Drug Administration (FDA) has approved 29 biosimilar products, with some biologics having between four and five biosimilars now available.   When FDA approved the country’s first biosimilar, Zarxio (filgrastim-sndz) , the prospect that these products could help address the high cost of biologics and patient access issues seemed promising. However, the reality five years later is that uptake of biosimilars appears to be slow and inconsistent...
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    Manhattan firm's "allergy drops" prompt CBER untitled letter

    The US Food and Drug Administration’s (FDA’s) biologics division has delivered an untitled letter to a Manhattan-based firm for marketing sublingual “allergy drops” from its Fifth Avenue address.   Curex, Inc. was the recipient of the missive sent 23 March by the Office of Compliance and Biologics Quality in FDA's Center for Biologics Evaluation and Research (CBER). On its website , Curex claims that its sublingual immunotherapy drops “are made using the same ingredie...