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BioPharmaceutical Europe Drug Approval Standards

Many PRIME Applicants Are Missing Pediatric Investigation Plans

  • News
  • Maureen Kenny
    Maureen Kenny

Executive Summary

Aside from pediatrics research issue, most of the first batch of applications for the new priority review scheme were "in scope," with numerous therapeutic areas targeted.

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First EU PRIME Designations Go To Biogen, ChemoCentryx, Kite, NovImmune

The first four drugs European Medicines Agency selects for its new priority review program include Biogen's Alzheimer's disease treatment aducanumab. Fourteen applicants did not garner PRIME status.

EMA's PRIME: Helpful But Not A Panacea

European Medicines Agency will try "just as hard" to aid companies who tap into other EU regulatory tools aimed at fostering quicker reviews, official says at BIA/MHRA conference.

EMA, FDA Get Together On Drugs Eligible For PRIME And Breakthrough Designation

Regulators will share ideas on how to facilitate parallel discussions on products submitted under PRIME and breakthrough.

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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