• RoundupsRoundups

    Euro Roundup: EMA streamlines processes to handle COVID-19 volume

    The European Medicines Agency (EMA) is temporarily revising its processes to cope with a rising volume of work related to the COVID-19 pandemic. EMA made the changes to ensure it can handle a “very active pipeline” that is expected to yield up to five COVID-19 therapies this year.   Faced with that workload, EMA is temporarily freeing co-rapporteurs from the need to provide their own assessment reports on initial marketing authorization applications for non-COVID-19 ...
  • RoundupsRoundups

    Euro Roundup: UK’s NICE launches five-year strategy

    The UK’s National Institute for Health and Care Excellence (NICE) on Monday announced a five-year strategy to revamp its approach to health technology assessments (HTA) to speed access to new and innovative treatments.   “The new strategy sets out a vision for the future where NICE will be more dynamic, work more collaboratively, and continue to build on the excellent foundations of the last 22 years,” said NICE Chief Executive Gillian Leng.   The strategy is built...
  • Regulatory NewsRegulatory News

    EMA, WHO investigate reported clots with AstraZeneca vaccine

    As countries in Europe and elsewhere continue to pause administration of the AstraZeneca COVID-19 vaccines over reports of clotting events in recipients, the European Medicines Agency (EMA) announced Monday that it worked through the weekend to analyze and make sense of these reports.   Continuing a “rigorous analysis of all the data related to thromboembolic events,” EMA announced that its safety committee (PRAC) will hold an extraordinary meeting on Thursday, 18 Ma...
  • ReconRecon

    Recon: 2021's priciest drugs; A leaderless FDA?

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Novartis' canakinumab failed to improve survival in Phase III trial ( Reuters ) ( Endpoints ) Is a leaderless FDA clamping down on drug reviews? Not knowing is weighing heavy on biotech ( STAT ) Pandemic Forces FDA to Sharply Curtail Drug Company Inspections ( NYT ) A Survey of Survival Outcomes for Targeted Cancer Drugs Approved by the US Food and Drug Admini...
  • Regulatory NewsRegulatory News

    How to handle COVID variants? Global regulators turn to flu vaccines

    A global consortium of regulators is turning to seasonal influenza vaccine authorization as a model for how to address variant-adjusted version of authorized COVID-19 vaccines.   New guidance available from the ACCESS consortium, including the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA), directs vaccine developers to focus on demonstrating robust immune response against new variants when trialing modified COVID-19 vaccines. In addition...
  • Regulatory NewsRegulatory News

    MHRA awards first ‘innovation passport’ under new pathway

    MSD's (Merck Sharp & Dohme (UK) Limited) investigational drug belzutifan on Friday became the first drug to be awarded an “innovation passport” under the UK Medicines and Healthcare products Regulatory Agency’s (MHRA) innovative licensing and access pathway (ILAP).   Belzutifan is being developed to treat adults with von Hippel-Lindau disease, a rare cancer-causing genetic disorder, and has been granted orphan designation in the EU and both orphan designation and br...
  • Regulatory NewsRegulatory News

    EMA, MHRA update on COVID vaccine pharmacovigilance

    Regulators in Europe are beginning to give safety readouts from global experiences with vaccines against COVID-19, while the United Kingdom has issued a report delineating its multi-pronged safety surveillance approach.   The European Medicines Agency’s safety committee met at the end of January to review data from clinical use of the COVID-19 messenger RNA (mRNA) vaccine co-developed by Moderna and the US National Institutes of Health.   Following a 28 January mee...
  • Regulatory NewsRegulatory News

    MHRA okays third COVID-19 vaccine

    As the first week of the new year winds down, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved a third vaccine against COVID-19. On Friday, MHRA announced its regulatory approval of the messenger RNA (mRNA) vaccine jointly developed by Moderna and the US National Institutes of Health.   “Having a third COVID-19 vaccine approved for supply following a robust and thorough assessment of all the available data is an important goal to have ac...
  • Regulatory NewsRegulatory News

    UPDATED: UK authorizes Oxford-AstraZeneca COVID-19 vaccine

    Editor’s note: This article was updated 04 January 2020 to include new information about EMA's review of the Oxford-AstraZeneca COVID-19 vaccine.   The United Kingdom has followed the recommendation of its Medicines and Healthcare products Regulatory Agency (MHRA) to issue temporary authorization for the vaccine against COVID-19 co-developed by Oxford University and AstraZeneca. The UK’s authorization is the first for the vaccine.   The authorization for temporar...
  • Regulatory NewsRegulatory News

    MHRA authorizes Pfizer-BioNTech COVID vaccine as FDA, EMA set more conservative timeline

    The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) granted temporary authorization on 2 December to Pfizer and BioNTech’s mRNA-based BNT162b2 COVID-19 vaccine, vaulting ahead of regulators in the US and EU.   The temporary authorization is “batch-specific” and applies only to a single batch of the vaccine. Subsequent batches must be approved by MHRA and must meet the same authorization conditions as the initial batch. MHRA said the decision was mad...
  • Regulatory NewsRegulatory News

    Sponsors get RWE guidance from MHRA

    The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has issued a draft guidance on the use of real-world evidence in clinical trials. The guidance, which remains open for consultation for 6 weeks from its 30 October publication date, is intended for sponsors planning clinical research in support of regulatory decisions.   MHRA notes that real-world evidence (RWE) may help investigators get at how a treatment will really work when it is in community use ...
  • Regulatory NewsRegulatory News

    MHRA issues post-transition orphan, Northern Ireland supply guidance

    The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Thursday issued post-transition guidance on orphan medicines designations and incentives, as well as guidance on supplying medicines from Great Britain to Northern Ireland.   The guidances are the latest in a suite of post-transition guidance from the agency as it prepares for the Brexit transition period to expire at the end of the year. (RELATED: MHRA posts suite of post-transition guidances , ...