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  • 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...
  • Regulatory NewsRegulatory News

    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...
  • ReconRecon

    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...
  • Regulatory NewsRegulatory News

    FDA launches portal for drug manufacturing volume reporting

    The US Food and Drug Administration (FDA) on Friday launched its new NextGen Portal for reporting manufacturing volume data for drugs and biologics under the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), along with two guidances to assist registrants with complying with the reporting requirements.   The portal and associated guidance come more than a year after FDA delayed the collection of drug manufacturing volume data in August 2020. At the time,...
  • ReconRecon

    Recon: US buys 50M doses of Pfizer vaccine for kids; Biden abandons drug pricing plans

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Pfizer gets U.S. contract for 50 mln COVID-19 vaccine doses for kids ( Reuters ) Biden abandons his push to lower drug prices ( STAT ) Be careful who you sue: CytoDyn knowingly submitted an incomplete drug application to FDA, new documents show ( STAT ) Merck ready to deploy tens of millions of its Covid antiviral pills if regulators approve, CEO says ( CNBC )...
  • Regulatory NewsRegulatory News

    OPDP plans more research on presentation of 'targeted' MoAs

    The US Food and Drug Administration's (FDA) Office of Prescription Drug Promotion (OPDP) this week proposed new research intended provide insights on how claims, graphics and disclosures about targeted mechanisms of action (MoA) influence consumer and health care provider (HCP) perceptions.   OPDP said it is particularly interested in finding out how different presentations of MoA affect consumers’ and HCPs’ understanding of a drug's MoA, its benefits and risks, attent...
  • ReconRecon

    Recon: Merck signs royalty-free deal with Medicines Patent Pool for molnupiravir; Cortexyme's Alzheimer's candidate misses primary endpoint

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Cortexyme's Alzheimer's treatment fails to meet main goals in study ( Reuters ) ( STAT ) Democratic senators raise concerns with potential FDA pick ( STAT ) This May Be Democrats’ Best Chance to Lower Drug Prices ( NYTimes ) Pharma Campaign Cash Delivered to Key Lawmakers With Surgical Precision ( KHN ) Democrats pitch industry-friendly Medicaid workaround to...