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  • ReconRecon

    Recon: Gilead to buy Immunomedics for $21B; Trump signs international reference pricing order

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Trump unveils plan to slash drug costs tied to what's paid abroad ( Politico ) ( NYTimes ) ( WSJ ) ( STAT ) Trump Pressed for Plasma Therapy. Officials Worry, Is an Unvetted Vaccine Next? ( NYTimes ) Gilead Reaches Deal to Buy Immunomedics for $21 Billion ( WSJ ) ( FT ) ( Reuters ) ( STAT ) Merck to buy $1 bln stake in Seattle Genetics, co-develop cancer thera...
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    Marks, Hahn confirm COVID vaccine EUA guidance coming

    The US Food and Drug Administration (FDA) will soon issue guidance on the data needed to support an emergency use authorization (EUA) for a vaccine to prevent coronavirus disease (COVID-19) according to Center for Biologics Evaluation and Research (CBER) Director Peter Marks.   Speaking at an event hosted by the Duke Margolis Center for Health Policy on Thursday, Marks hinted that additional guidance on EUAs for COVID-19 vaccines would be coming soon.   “You may ...
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    Recon: US trials blood thinners in COVID patients; Pharma’s campaign against ICER

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Marks: Prepare for 'EUA-plus' for Covid vaccines ( Politico ) ( Pink Sheet ) FDA chief says he has ‘no intention’ of overruling career staff on coronavirus vaccine decision ( CNBC ) Covid vaccine becomes divisive issue in US election campaign ( FT ) FDA Regulators Publish Rare Self-Defense Amid Rising Vaccine Pressure ( NYTimes ) Big Pharma wages stealth war ...
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    FDA calls for stakeholders to join GDUFA talks

    The US Food and Drug Administration (FDA) this week called on non-industry stakeholders, including advocacy groups, healthcare professionals and other experts, to declare their interest in participating in consultation meetings for the next Generic Drug User Fee Amendments (GDUFA III) program.   The call comes less than two months after the agency held its GDUFA III reauthorization kickoff meeting, during which industry stakeholders sought improvements to the generic...
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    Recon: FDA approves GSK's three-drug asthma inhaler; EMA extends review of BioMarin gene therapy

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Senior FDA career executives: We're following the science to protect public health in pandemic ( USA Today ) The coronavirus pandemic underscores the need to bring drug manufacturing back to US ( CNBC ) Several Covid-19 Vaccines Could Join Winner’s Circle ( WSJ ) GSK's three-drug inhaler wins US nod for use in asthma patients ( Reuters ) ( Endpoints ) Trump s...
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    CDRH officials reflect on COVID diagnostics approach

    In a perspective published in the New England Journal of Medicine on Wednesday, top officials overseeing diagnostics at the US Food and Drug Administration (FDA) reflect on lessons learned during the agency’s response to the coronavirus disease (COVID-19) public health emergency.   On 4 February, just weeks after the first case of COVID-19 was detected in the US, FDA issued an emergency use authorization (EUA) for a test developed by the Centers for Disease Control...
  • ReconRecon

    Recon: AstraZeneca halts COVID vaccine trial; France fines Roche, Novartis €444 over Lucentis marketing

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US How drugmakers can keep their pledge and still deliver an October vaccine surprise ( Reuters ) FDA Sets Up Vaccine Safeguards to Counter Pressure From Trump ( Bloomberg ) FDA authorizes emergency use of COVID-19 test from Alphabet's Verily ( Reuters ) Liquid biopsy startup Grail, in filing for IPO, lays out investments and plans for growth ( STAT ) Drug, devi...
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    Drugmakers, FDA try to build public confidence in COVID vaccine decisions

    The CEOs of nine pharmaceutical companies working to develop vaccines for coronavirus disease (COVID-19) on Tuesday pledged not to seek approval or emergency use authorization (EUA) for a vaccine until they have demonstrated safety and efficacy through Phase 3 clinical trials.   The CEOs, who head vaccine front-runners AstraZeneca, Moderna and partners Pfizer and BioNTech, as well as GlaxoSmithKline, Johnson & Johnson, Merck, Novavax and Sanofi, also say they will pu...
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    Pharmacovigilance and QPPV: Post-transition guidance from MHRA

    The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) this week issued guidance detailing post-transition pharmacovigilance procedures and requirements for having a qualified person responsible for pharmacovigilance (QPPV) and a pharmacovigilance system master file (PSMF) for UK authorized products.   Pharmacovigilance   MHRA says it “will retain responsibility for pharmacovigilance across the UK from 1 January 2021,” but notes that there will be di...
  • ReconRecon

    Recon: Russian COVID vaccine shows antibody response in early trials; AbbVie to develop, sell I-Mab cancer drug

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Covid-19 Vaccine Race Turns Deep Freezers Into a Hot Commodity ( WSJ ) Leader of US vaccine push says he‘ll quit if politics trumps science ( Science ) ( NPR ) US will not 'cut corners' in developing coronavirus vaccine, Pence says ( Reuters ) White House: no one pressuring FDA to approve coronavirus vaccine ( Reuters ) Moderna slows vaccine trial enrollment ...
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    MHRA: Post-transition guidance on licensing medicines

    In its suite of post-transition guidances released Tuesday, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) issued a dozen documents explaining how medicines licensure will work after the Brexit transition period expires on 1 January 2021.   The guidance, which largely mirrors the “no deal” scenario laid out in now-withdrawn guidance issued last year, explains a range of issues from converting centrally authorized products (CAPs) to UK marketing au...
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    Recon: CDC tells states to prep for COVID vaccine by November; 76 wealthy countries join COVAX plan

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Trump Admin Asks States to Be Ready for Vaccine by November ( WSJ ) ( Reuters ) ( NYTimes ) ( FT ) Pfizer targets end of next month for COVID-19 vaccine update ( Reuters ) Unlikely that a COVID-19 vaccine will be ready in October, but not impossible, Fauci says ( Reuters ) Merck CEO sees human trials for COVID-19 vaccine candidate 'fairly soon' ( Reuters ) Pr...