• Regulatory NewsRegulatory News

    IVDR’s progressive rollout gets official with EU Council, Parliament adoption

    The progressive rollout of the In Vitro Diagnostic Medical Devices Regulation (IVDR) is now official, after the European Parliament and Council adopted an amendment setting new dates of application for some of the regulation’s requirements.   Following significant pressure from industry and facing fears of a market collapse for diagnostics amid the COVID-19 pandemic, the European Commission announced it would delay certain provisions of the IVDR in October. The Commi...
  • Regulatory NewsRegulatory News

    Fall Unified Agenda: A look at FDA’s planned rulemaking

    The Biden administration’s second regulatory agenda for the US Food and Drug Administration (FDA) largely picks up where the previous agenda left off.   Released by the White House Office of Management and Budget last week, the Fall 2021 Agency Rule List contains 85 proposed and final rules the agency plans to issue under FDA’s purview. More than half of those rules pertain to human medical products or their development, with the remainder related to animal medical pro...
  • ReconRecon

    Recon: EU states can offer early access to Pfizer’s COVID pill; Biogen to submit final designs for Aduhelm postmarketing study in March

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Biogen plans to submit final design of Aduhelm confirmatory trial to FDA in March ( Reuters ) As Aduhelm faces doubts, Biogen plans another pivotal trial for 2022 ( STAT ) Uncoordinated and redundant: FDA's Pazdur slams checkpoint inhibitor developers for creating a 'Wild West’ ( Endpoints ) A C.D.C. panel is meeting on a blood clot risk linked to J.&J.’s vacc...
  • ReconRecon

    Recon: EMA backs J&J booster; Califf on track for confirmation with GOP support

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Manchin, Sanders will oppose Biden FDA nominee Califf ( The Hill ) Biden’s FDA pick on track for confirmation with GOP help ( Politico ) Bristol Myers drug wins first U.S. approval for Graft versus Host Disease prevention ( Reuters ) ( FDA ) HHS secretary hints that more federal funds may be needed to fight an Omicron surge. ( NYTimes ) Opioid Makers Cement C...
  • Regulatory NewsRegulatory News

    Califf skates through nomination hearing

    Despite some rumbling about his ties to the pharmaceutical and tech industries, Robert Califf breezed through a two-hour nomination hearing on Tuesday for a second stint as commissioner of the US Food and Drug Administration (FDA).   Califf’s nomination by President Joe Biden last month came after a protracted period of speculation as to who would be chosen to lead FDA at an unprecedented time in the agency’s history. During the hearing, Califf laid out three overarchi...
  • ReconRecon

    Recon: Pfizer to buy Arena for $6.7B; Novartis sees strong interest in Sandoz unit

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Pfizer bets on Arena's promising bowel disease treatment in $6.7 bln deal ( Reuters ) A year after first U.S. shots, pandemic hallmarks re-emerge ( Reuters ) Out of Control: America’s losing battle against diabetes ( Reuters ) Drugmakers aim big price hikes at U.S. patients, congressional report finds ( Reuters ) ( STAT ) ( Politico ) Moderna's flu data offer...
  • Regulatory NewsRegulatory News

    This Week at FDA: Bardoxalone strikes out at adcomm; Updated device consensus standards

    Happy Friday – this week we’re juggling lots of end-of-year activity from the US Food and Drug Administration (FDA). Today and in the next week, look for our contributors to highlight several draft and final guidance documents and to provide analysis and background on industry’s reactions to other guidances whose comment periods have recently closed.   The Center for Drug Evaluation and Research (CDER) released its fall/winter 2021 regulatory science news update today....
  • Regulatory NewsRegulatory News

    MDCG offers new guidance on clinical investigations, importers and distributors

    The European Commission’s Medical Devices Coordination Group (MDCG) on Thursday issued new guidance documents offering questions and answers on the import and distribution of medical devices. The group also provided sponsors with a template for notifying member states of a substantial modification to a clinical investigation, to be used as a stopgap before the Eudamed electronic reporting system is fully functional.   Importers and distributors   In its 11-page que...
  • ReconRecon

    Recon: FDA authorizes Pfizer booster for 16 and 17 year olds; China approves Brii Biosciences’ COVID antibody

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA expands authorization for Pfizer’s Covid-19 booster to cover 16- and 17-year-olds ( STAT ) ( FDA ) AstraZeneca Covid-19 Antibody Authorized by FDA as Novel Tool to Prevent Symptomatic Disease ( WSJ ) ( NYTimes ) ( FDA ) U.S. campaign to vaccinate young children off to sluggish start despite abundant supply ( Reuters ) Becerra names incoming acting NIH dire...
  • ReconRecon

    Recon: Pfizer says vaccine neutralizes Omicron after three doses; FTC settles with Vyera over Daraprim practices

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Pfizer, BioNTech vaccine neutralises Omicron with three shots ( Reuters ) ( STAT ) Studies suggest Pfizer shot may protect only partially against Omicron ( Reuters ) Pfizer will submit full data on Covid treatment pill to the FDA in a few days, CEO says ( CNBC ) AbbVie settles New York opioid case as trial winds down ( Reuters ) U.S. FTC settles with Vyera ov...
  • Regulatory NewsRegulatory News

    EMA responds to MEPs’ inquiry on COVID vaccines, data integrity concerns

    The European Medicines Agency (EMA) on Friday responded to an inquiry from several members of the European Parliament (MEPs) concerning the agency’s reviews of the mRNA COVID-19 vaccines developed by Pfizer/BioNTech and Moderna, as well as a report published last month in The BMJ that raised concerns about data integrity at a US trial site for Pfizer’s vaccine.   In her response to the inquiry, sent by MEPs Michèle Rivasi, Piernicola Pedicini and Tilly Metz, EMA Exec...
  • ReconRecon

    Recon: EU agencies recommend mix-and-match COVID vaccines; Biden touts drug pricing plans in social spending bill

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Biden touts drug pricing plan in push for social spending bill ( Politico ) ( NYTimes ) J&J squares up to Big Pharma rivals with extra RSV vaccine data ( Fierce ) Former Pharma Executive Charged With Embezzling Millions ( AP ) Flagship to launch a new startup focused on neurodegenerative conditions, including Parkinson’s ( STAT ) Targeting prices for accelera...