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  • ReconRecon

    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...
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    Industry calls for technical, scope changes in ICH S12 guideline

    In response to the US Food and Drug Administration's (FDA) consultation on the International Council for Harmonisation's (ICH) S12 guideline on nonclinical biodistribution considerations for gene therapy products, two industry groups and drugmaker Novartis have suggested changes to the document.   The guideline reached Step 2b of the ICH process in June and has been released for comment by regulators, including the European Medicines Agency (EMA), to gather feedback be...
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    Recon: Valneva secures EU deal for its vaccine; TGA requests additional info from Pfizer after BMJ report

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Pfizer seeks FDA nod for COVID vaccine boosters for U.S. adults ( Reuters ) ( NYTimes ) Moderna and U.S. at Odds Over Vaccine Patent Rights ( NYTimes ) Theranos lab deficiencies posed ‘immediate jeopardy’ to patients, 2016 government audit warned ( CNBC ) Medtech sounds alarm on semiconductor shortages, asks feds to prioritize chips for medical use ( MedtechDi...
  • ReconRecon

    Recon: US to buy $1B more of Merck's COVID-19 pill; AstraZeneca to create new division for vaccines and antibodies

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US U.S. government to buy $1 billion more worth of Merck's COVID-19 pill ( Reuters ) Inovio says the FDA lifted its 'hold' on the Phase 3 clinical trial for its COVID-19 shot ( MarketWatch ) GE Healthcare to become standalone company after conglomerate completes three-way split ( Fierce ) ( CNBC ) Surgical device maker Arthrex fined $16M over alleged kickback sch...
  • Regulatory NewsRegulatory News

    EMA to offer recommendation on national use for Merck's molnupiravir

    The European Medicines Agency (EMA) on Monday announced it is reviewing Merck Sharp & Dohme and Ridgeback Biotherapeutics' antiviral drug Lagevrio (molnupiravir) to treat COVID-19 in an effort to provide guidance on the drug's use to national authorities prior to its EU-wide authorization.   The review, which is being conducted under Article 5(3) of Regulation (EC) No 726/2004, will allow the agency to provide a harmonized scientific opinion on the use of the molnupira...
  • ReconRecon

    Recon: Pfizer expected to seek broader authorization for COVID booster; Regeneron says antibody reduces risk of contracting COVID for up to 8 months

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Pfizer says its antiviral pill slashes risk of severe COVID-19 by 89% ( Reuters ) ( STAT ) Pfizer-BioNTech expected to seek authorization for coronavirus booster for people 18 and older ( Washington Post ) ( Reuters ) Regeneron's COVID antibody drug shows protection for up to 8 months ( Reuters ) Dems' $100B deal reduced further: Medicare drug price negotiatio...
  • Regulatory NewsRegulatory News

    This Week at FDA: New proposed rules, Biocon's Form 483, and more

    We're trying something new at Regulatory Focus , with the goal of gathering the week’s news from (and about) FDA. We'll be covering agency activities and enforcement actions, filings in the Federal Register , new guidances, legislative updates, and anything else we come across – all in one place. We hope you will find it to be your one-stop-shop for FDA updates. What do you think? We’d be happy to hear your feedback at news@raps.org. News from this week One of t...
  • ReconRecon

    Recon: UK authorizes Merck's COVID-19 antiviral pill; EMA reviewing AstraZeneca boosters

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Moderna struggles with vaccine ramp-up, cuts 2021 sales view; shares drop ( Reuters ) ‘The beginning of a long journey’: A progress report on Big Retail’s ambitions in health care ( STAT ) CAR-T therapies from Bristol, Gilead superior to standard treatment in blood cancer, studies show ( STAT ) Drugmakers pushed aggressive diabetes therapy. Patients paid the p...
  • ReconRecon

    Recon: Democrats cobble together drug pricing deal; WHO grants emergency use listing to Bharat Biotech's COVID vaccine

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Democrats Add Drug Cost Curbs to Social Policy Plan, Pushing for Vote ( NYTimes ) ( STAT ) Covid-19: Researcher blows the whistle on data integrity issues in Pfizer’s vaccine trial ( The BMJ ) U.S. begins vaccinating its youngest against COVID-19 ( Reuters ) CDC advisers endorse Pfizer’s Covid-19 vaccine for kids 5-11 ( STAT ) With two new insurance partnersh...
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    GDUFA III commitment letter details coming changes to FDA's generic review program

    With the negotiations for the third iteration of the Generic Drug User Fee Amendments (GDUFA III) program completed, the US Food and Drug Administration (FDA) has released the commitment letter laying out its performance goals and the program enhancements that will shape the program over the next five years.   The commitment letter follows a year-long process of meetings and negotiation sessions to gather input from the public, industry and other stakeholders on the ag...
  • ReconRecon

    Recon: Opioid makers score a win in California trial; Pfizer sees 2021, 2022 COVID vaccine sales to hit $65B

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Opioid Makers Win Major Victory in California Trial ( NYTimes ) ( Reuters ) ( STAT ) Pfizer expects 2021, 2022 COVID-19 vaccine sales to total at least $65 bln ( Reuters ) ( FT ) U.S. CDC advisers to vote on COVID-19 vaccine in young children ( Reuters ) FDA extends review of J&J, Legend's cell therapy for multiple myeloma ( BioPharmaDive ) Progressive Democr...
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    Recon: Novavax gets first emergency authorization in Indonesia; J&J pays $800M to settle most Risperdal suits

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Moderna says FDA needs more time to complete review of its COVID-19 shot for adolescents ( Reuters ) ( NYTimes ) Orphan drug tax credit on the chopping block again under Dem spending bill ( Endpoints ) Pelosi working to gather support for last-minute, last-ditch drug pricing policy ( STAT ) In key win, AbbVie lands FDA approval for Allergan's blurred-vision ey...