• Regulatory NewsRegulatory News

    Pazdur mounts defense of accelerated approval during Cures 2.0 panel

    During a listening session convened by the Friends of Cancer Research (FOCR) with Reps. Diana DeGette (D-CO) and Fred Upton (R-MI) on their nascent Cures 2.0 package, Richard Pazdur, director of the US Food and Drug Administration’s (FDA) Oncology Center of Excellence (OCE) defended the agency’s accelerated approval program.   (RELATED: Cures 2.0: Discussion draft signals impact on FDA, creation of ARPA-H , Regulatory Focus 23 June 2021)   Asked by DeGette w...
  • ReconRecon

    Recon: US authorities probing Emergent over vaccine issues; Japan authorizes AstraZeneca vaccine after delay

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Biden pushes cash reward to get vaccinated, new rules for federal workers ( Reuters ) US authorities probing Emergent BioSolutions over COVID-19 vaccine issues- filing ( Reuters ) Cavazzoni in the hot seat: House committee grills CDER director on neuro drugs ( Endpoints ) ( STAT ) States could get billions from opioid lawsuits. They have to decide how to spend...
  • ReconRecon

    Recon: Emergent to resume J&J vaccine production; Sanofi raises profit forecast

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Citing New Data, Pfizer Outlines Case for Booster Shots ( NYTimes ) J&J says US FDA agrees to extend shelf life of its COVID-19 vaccine ( Reuters ) Emergent to resume J&J COVID-19 vaccine production at Baltimore plant ( Reuters ) ( WSJ ) U.S. House panel seeks J&J documents on baby powder bankruptcy plans ( Reuters ) AstraZeneca CEO hopeful COVID-19 vaccine m...
  • Regulatory NewsRegulatory News

    FDA sets deadline for study data technical rejection criteria

    The US Food and Drug Administration (FDA) has set a deadline for when it will begin refusing to file or to receive electronic submissions that fail to meet the agency’s established electronic common technical document (eCTD) validation criteria.   Beginning 15 September 2021, FDA says it will “reject submissions that contain any high validation errors included in the [technical rejection criteria] TRC.” The new effective date for the technical rejection criteria was an...
  • Regulatory NewsRegulatory News

    House E&C leaders grill FDA on inspection backlog

    Leaders of the House Energy and Commerce committee on Thursday wrote to Janet Woodcock, the US Food and Drug Administration's (FDA) acting commissioner, requesting information about the agency's plans to address its inspection backlog driven by the lull in on-site inspections during the COVID-19 pandemic.   In March 2020, when the scope and seriousness of the pandemic became known, FDA halted all but mission-critical inspections, relying instead on alternative tools su...
  • ReconRecon

    Recon: US buys 200M more doses of Pfizer vaccine; European Commission opens in-depth investigation into Illumina's bid to acquire Grail

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US United States buys 200 mln more doses of Pfizer/BioNTech COVID-19 vaccine ( Reuters ) CDC advisers hold off on Covid booster shot call ( Politico ) ( WSJ ) U.S. CDC advisers back J&J COVID-19 vaccine benefits amid neurological illness reports ( Reuters ) Facing Headwinds on New Alzheimer’s Drug, Biogen Launches Controversial Campaign ( KHN ) AstraZeneca's onc...
  • Regulatory NewsRegulatory News

    Woodcock: FDA needs expanded authority on device shortages

    The US Food and Drug Administration's (FDA) Acting Commissioner Janet Woodcock on Wednesday made a push for new funding to increase the resilience of the medical device supply chain and to expand the agency's authority to collect information about device shortages.   "The pandemic has exposed great weaknesses in the medical device supply chain and its dependence on foreign medical devices. To ensure the US is properly prepared now, and in the future, we must take actio...
  • ReconRecon

    Recon: Roche in talks with FDA on Alzheimer's candidate; Pfizer bets $1B on Arvinas' protein degrader

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Roche in talks with FDA on Alzheimer's candidate, says CEO ( Reuters ) States reach $26 billion deal with three wholesalers and J&J to end opioid lawsuits ( STAT ) ( NYTimes ) Merck, Eisai notch full approval for Keytruda-TKI inhibitor combo in advanced endometrial cancer ( Endpoints ) ( FDA ) Pfizer bets $1B cash on the original protein degraders as technolog...
  • Regulatory NewsRegulatory News

    House committee advances bills on advanced manufacturing, opioids and more

    Following a brief markup on Wednesday, the House Energy and Commerce Committee advanced 24 bipartisan health- and cybersecurity-related bills to the House for consideration, including bills aimed at advanced and continuous manufacturing for pharmaceuticals, supporting vaccination and addressing the ongoing opioid crisis. The first bill to be considered during the markup would amend the 21 st Century Cures Act to enable the US Food and Drug Administration (FDA) to des...
  • ReconRecon

    Recon: J&J forecasts $2.5B in 2021 COVID vaccine sales; South Africa’s Biovac to make Pfizer-BioNTech vaccine in 2022

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Anthem still determining coverage policy for Biogen Alzheimer's drug ( Reuters ) Biogen Alzheimer's drug slow to take off as US Medicare wrestles with coverage ( Reuters ) Drugmakers, pharmacies next targets for US opioid settlements ( Reuters ) Former FDA adviser calls for wider probe into Biogen Alzheimer's drug approval ( Reuters ) J&J forecasts $2.5 bln i...
  • Regulatory NewsRegulatory News

    Senators press Woodcock on COVID vaccines, boosters

    Senators on both sides of the aisle pressed Janet Woodcock, acting commissioner of the US Food and Drug Administration (FDA), and other officials during a hearing on Tuesday. The senators asked for specifics on the timing of COVID-19 vaccine booster shots and when the vaccines currently authorized for emergency use might obtain full approval.   More than a year into the COVID-19 pandemic, the full Senate Health, Education, Labor and Pensions committee met to explore th...
  • ReconRecon

    Recon: BioNTech buys production site, T-cell platform from Gilead; China approves AstraZeneca’s Imfinzi for aggressive form of lung cancer

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US BioNTech strengthens cancer therapy expertise with US acquisition ( Reuters ) ( Endpoints ) FDA investigating how a known carcinogen wound up in J&J sunscreen ( Reuters ) US to allow temporary rise in impurities in anti-smoking drug ( Reuters ) ( FDA ) Kadmon wins approval for drug to treat chronic graft-versus-host disease ( STAT ) ( FDA ) FDA Approves New U...