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Europe Review Pathway BioPharmaceutical

EU Accelerated Assessment Tracker

Bayer and Takeda Fail In Quest For Fast-Track Review

  • News
  • Maureen Kenny
    Maureen Kenny

Executive Summary

EU marketing authorization applications from Bayer for copanlisib and from Takeda for maribavir will be reviewed under standard timelines at the European Medicines Agency. 

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Gilead’s Lenacapavir, Takeda’s Maribavir Due For Oral Explanations At EMA

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Marketing applications for two generic versions of the multiple sclerosis blockbuster, Tecfidera, are also under review by the European Medicines Agency.

Immunocore and Argenx Among Fast-Track Hopefuls At EMA

EU reviewers will decide this week whether to grant accelerated assessment to a handful of new dug candidates that will soon be filed for approval.

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