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  • Regulatory NewsRegulatory News

    CHMP: Test all metformin for nitrosamines before release

    Medicines containing the diabetes medication metformin must be tested for the presence of nitrosamines before being released into the European market, said a committee of the European Medicines Agency (EMA) following its scheduled September meeting.   “As of October 2020, EMA and the national competent authorities are asking marketing authorization holders for metformin-containing medicines to test their medicines before releasing them onto the market,” said EMA’s Comm...
  • ReconRecon

    Recon: New healthcare investing record; Sanofi slim-down, sell-off?

    Recon:   Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Cuomo: Public should be 'very skeptical' about COVID-19 vaccine ( The Hill ) Dr. Scott Gottlieb: U.S. in 7th inning of the pandemic but the ‘hardest part’ is likely ahead ( CNBC ) For Trump, Covid-19 therapeutics are the new vaccines ( STAT ) Whatever happened to Deborah Birx? ( The Hill ) What about the German negotiation model? Biden steers ...
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    Study: Few new drugs have high therapeutic value

    A new study published in The BMJ  finds that only a third of new drugs approved by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) in the decade from 2007-2017 have high therapeutic value, according to appraisal by one of five independent organizations.   However, the analysis found that drugs approved through expedited programs – and especially EMA’s programs – were more likely to have high therapeutic value.   “Most of the incre...
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    EMA offers new Q&A on data monitoring committees

    The European Medicines Agency (EMA) on Thursday released a new guideline offering nine questions and answers on issues related to the role of data monitoring committees (DMCs) in the conduct and management of clinical trials.   EMA explains that the recommendations of DMCs are not binding for trial sponsors, but that sponsors should justify and document and instances where such recommendations are not followed.   “The ultimate responsibility for a clinical trial re...
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    EMA moves to IRIS for scientific advice questions

    The European Medicines Agency (EMA) is transitioning to an online platform for drug developers to use when requesting scientific advice. The change will become effective on 19 October for developers of both human and veterinary medicinal products.   The regulatory and scientific information management platform, known as IRIS , “aims to make the handling of product-related regulatory procedures more efficient and user-friendly and to ensure better data quality through ...
  • Regulatory NewsRegulatory News

    CHMP starts rolling review of Pfizer/BioNTech COVID vaccine

    A second candidate vaccine against COVID-19 is undergoing rolling review by the European Medicines Agency (EMA), as the agency begins with evaluation of pre-clinical data to support approval of a coronavirus vaccine during the pandemic.   The human medicines committee of the agency, known as CHMP, announced on 6 October that it was initiating a rolling review of the messenger ribonucleic acid (mRNA) vaccine under development by Pfizer in collaboration with the German p...
  • ReconRecon

    Recon: Breakthrough status for Farxiga; 'Transformative' Zolgensma data

        Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US President Trump Tests Positive for Coronavirus ( WSJ ) ( NYT ) ( Washington Post ) ( CNBC ) ( Politico ) ( BBC ) ( Reuters ) First doses of US vaccine must be strictly rationed, says report ( Financial Times ) Dr. Scott Gottlieb sees antiviral remdesivir as best coronavirus treatment should Trump need one ( CNBC ) Where was Trump — and who was he with ...
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    EMA kicks off rolling review of AstraZeneca COVID vaccine candidate

    The European Medicines Agency (EMA) has begun a rolling review of the COVID-19 vaccine being developed by AstraZeneca and the University of Oxford. This is the agency’s first review of a vaccine against SARS-CoV-2, the virus that causes COVID-19.   EMA’s human medicines committee (CHMP) has begun with an evaluation of non-clinical data, announced EMA on 1 October. The rolling review is meant to hasten the time to a decision on the safety and effectiveness of a therap...
  • Regulatory NewsRegulatory News

    EMA addresses use of registry-based studies

    The European Medicines Agency (EMA) has issued a new guideline on registry-based studies, giving detailed advice for use of patient registries in both the pre- and post-authorization phases for medicinal products.    After committee approval and a consultation period with the EU Regulatory Network, the guideline has been released for public consultation, with comments due before the end of 2020.   The guideline’s focus is on the use of patient registries for studie...
  • Regulatory NewsRegulatory News

    EMA backs dexamethasone for COVID-19, seven new medicines and consults on ICH Q3D guideline

    The European Medicines Agency’s (EMA) on Friday recommended seven medicines for marketing authorization and began a public consultation on the International Council for Harmonisation’s (ICH) Q3D(R2) guideline on elemental impurities.   EMA also endorsed the use of dexamethasone to treat coronavirus disease (COVID-19) patients who are on oxygen or mechanical ventilation based on results from the RECOVERY trial.   “Published data from the RECOVERY study show that, in...
  • Regulatory NewsRegulatory News

    Convergence: Global planning is key to successful development of companion diagnostics

    Planning and alignment are the keys to successfully steering companion diagnostics through regulatory processes across the globe, according to experts who spoke at RAPS Convergence 2020.   “The most critical way to develop a companion diagnostic is really a coordinated, co-development model, and this is the most effective path to regulatory approval,” said Ken Butz, associate director of regulatory technical advisors at PPD, and the leader of a session on the evolving ...
  • Regulatory NewsRegulatory News

    Convergence: EMA close to finalizing guidance for advanced therapies

    The European Medicines Agency is on the verge of releasing revised guidance for advanced therapy medicinal products containing genetically modified cells, which includes chimeric antigen receptor (CAR)-T cell therapies. The “Guideline on quality, non-clinical and clinical aspects of medicinal products containing genetically modified cells” was originally issued in 2012 but underwent revision and consultation from July 2018-July 2019. The revised version is expected to...