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  • ReconRecon

    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...
  • Regulatory NewsRegulatory News

    FDA clarifies EUAs for COVID multi-analyte respiratory panels

    Manufacturers can request emergency use authorizations under the public health emergency of the coronavirus pandemic for multi-analyte respiratory panels, the US Food and Drug Administration (FDA) clarified on 9 September.   The agency added a new item to its questions and answers (Q&As) for laboratories and manufacturers of tests for SARS-CoV-2, the virus that causes COVID-19.   The new Q&A cites “the overlap in signs and symptoms between SARS-CoV-2 and other resp...
  • 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...
  • RoundupsRoundups

    FDA Approvals Roundup: Gavreto and Trulicity

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA). New approval Gavreto approved for metastatic lung cancer with RET gene fusions Blueprint Medicines’ Gavreto (pralsetinib capsules) has been granted accelerated approval for treating adults with metastatic non‒small cell lung cancer (NSCLC) whose tumors test positive for rearranged during transfection (RET) fusion in an accompanying biomarker assay.   The ass...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    FDA updates PK guidance for patients with impaired renal function

    The US Food and Drug Administration (FDA) has updated its draft guidance for the design and analysis of trials to assess how impaired renal function impacts the pharmacokinetics and pharmacodynamics of investigational drugs. The guidance , issued on 03 September 2020, provides an update to a previous draft issued in March 2010. Specifically, the new document offers updated advice on when a standalone pharmacokinetic study is necessary, the appropriate study design, con...
  • Regulatory NewsRegulatory News

    FDA warns firm: Test batches before, not after release

    An Indonesian firm was warned by the US Food and Drug Administration (FDA) for failures in product testing and method validation, among other breaches of current good manufacturing practice (CGMP).   In a November 2019 inspection of PT. MegaSura Mas, FDA inspectors found that some assays conducted for batch releases of an over-the-counter product were performed after the batches were released. “This discrepancy on batch release documents demonstrates a concern regardin...
  • ReconRecon

    Recon: China vaccinates 100K for COVID; EUA for Roche COVID-flu combo test

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Genentech scores sixth FDA approval in lung cancer with Gavreto ( Pharmafile ) US FDA Personnel Costs Drop: Is the Next Generation Taking Over? ( Pink Sheet ) Gottlieb: Staged Access To Coronavirus Vaccine Possible Through EUA ( Pink Sheet ) Why Saving The Economy Or Tackling The Pandemic Is A False Dilemma ( Forbes ) Here’s how Trump could bigfoot the FDA an...
  • 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 ...
  • Regulatory NewsRegulatory News

    COVID convalescent plasma guidance gets EUA updates

    Guidance for industry on the use of convalescent plasma for patients with COVID-19 has been updated to reflect the 23 August Emergency Use Authorization (EUA) for the investigational product. The guidance clarifies which pathways are available for use of COVID-19 convalescent plasma and announces a period of enforcement discretion for transition to collection requirements outlined in the EUA.   Updates to the US Food and Drug Administration (FDA) guidance account for...
  • ReconRecon

    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...
  • RoundupsRoundups

    FDA Roundup: Sogroya, Onureg, Winlevi

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA). New approvals Sogroya okayed as weekly therapy for adult growth hormone deficiency Novo Nordisk’s Sogroya (somapacitan-beco injection) has been approved as the first once-weekly, human growth hormone (hGH) therapy for adults with growth hormone deficiency.   Until now, the only treatment option for patients with the disorder has been a daily formulation of t...