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    EMA judges AstraZeneca vaccine safe after blood clot investigation

    After an all-day meeting that ran beyond its scheduled end, the safety committee of the European Medicines Agency (EMA) concluded Thursday that the benefits of receiving the AstraZeneca COVID-19 vaccine outweigh any potential risks of side effects, including thromboembolic events.   Overall, the rate of clotting events was not higher in vaccine recipients than in the general population. However, PRAC, EMA’s safety committee, is paying attention to a small subset of eve...
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    EMA chief says Pfizer, Moderna data ‘very robust,’ defends vaccine review approach

    Emer Cooke, the European Medicines Agency’s (EMA) newly installed executive director, on Thursday told a European Parliament committee that data submitted in support of COVID-19 vaccines developed by Pfizer/BioNTech and Moderna are “very robust”.   The meeting occurred hours before the US Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee would meet to discuss authorizing the Pfizer/BioNTech vaccine for emergency use and ju...
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    Rasi signs off as EMA chief, Cooke to take the reins amid pandemic

    Guido Rasi, the European Medicines Agency’s (EMA) long-serving executive director, ended his second five-year term on Friday, handing the reins to Emer Cooke, who is returning to the agency after a stint at the World Health Organization (WHO).   Cooke, who will be the first woman to lead the agency in its 25-year history after being nominated for the role in June, will begin her tenure at the height of the COVID-19 pandemic where her role as the EU’s top regulator will...
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    EMA nominates executive director to replace Rasi

    The European Medicines Agency’s (EMA) Management Board on Thursday nominated Emer Cooke from a short list of candidates to succeed Guido Rasi as the agency’s next executive director.   Rasi, whose second term as EMA executive director ends on 15 November, served as Executive Director from 2011-2014 before being forced to step down after the European Union Civil Service Tribunal annulled his appointment. (RELATED: Rasi returns to head EMA for five-year term , Regula...
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    European Regulatory Roundup: EMA to Discuss Future of Adaptive Pathways Program (15 September 2016)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. EMA Schedules Workshop to Discuss Adaptive Pathway Program The European Medicines Agency (EMA) has scheduled a meeting to hear what drug developers and other groups have to say about its adaptive pathways program. EMA is presenting the workshop as an opportunity to discuss the lessons of the two-year pilot program and figure out the future of the staged approach to drug app...