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BioWorld - Thursday, May 19, 2022

EMA

Home » Topics » Regulatory » EMA
  • European flag vaccine
    April 25, 2022
    By Richard Staines

    European regulators delay decision on Valneva COVID shot again, asking for antibody data

    Shares in Valneva SE fell sharply after the company said European regulators came back with further queries, including on antibody efficacy data, instead of a recommendation during a rolling review of its delayed COVID-19 vaccine. The company had expected a positive opinion on the vaccine, known as VLA-2001, following the April meeting of the European Medicines Agency’s CHMP committee.
  • Aduhelm product image
    April 22, 2022
    By Richard Staines

    Biogen withdraws EU Aduhelm filing amid announcement of latest CHMP opinions

    Biogen Inc. has given up on its attempt to get its Alzheimer’s disease drug Aduhelm (aducanumab) approved by regulators in Europe, deciding to withdraw its filing midway through a review of a previous rejection. The company had asked the European Medicines Agency’s CHMP to reconsider its negative opinion for Aduhelm in December 2021. But its subsidiary in the Netherlands wrote to the EMA this week saying that it had decided to withdraw its marketing authorization application after all.
  • Europe map
    April 1, 2022
    By Mari Serebrov

    EU issuing wartime advice on clinical trials

    With the Russian invasion of Ukraine continuing to disrupt thousands of clinical trials throughout the region, the European Commission, the EMA and the Heads of Medicines Agencies are developing advice to help sponsors mitigate the issues. For now, sponsors should apply the approaches and flexibilities used during the COVID-19 pandemic to the current situation, the groups said March 30.
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Authors

  • Nuala Moran
  • Randy Osborne
  • Cormac Sheridan
  • Mari Serebrov
  • Michael Fitzhugh
  • Elise Mak
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