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Albireo Pharma, Inc.

https://www.albireopharma.com/

Latest From Albireo Pharma, Inc.

Rejection Rate Soars In Q4 For EU Fast-Track Requests

October and November 2020 were bad months for companies seeking to have their planned EU filings fast-tracked through the centralized drug review system at the European Medicines Agency.

Europe Review Pathway

EU Accelerated Assessment Tracker

Bayer has failed to convince the European Medicines Agency that its marketing authorization application for finerenone should be fast-tracked through the EU's centralized review process. There were other successes, though, although Janssen is keeping us guessing over its MAA for amivantamab. These and other developments relating to the agency's accelerated assessment mechanism are logged in this latest update to the Pink Sheet's EU accelerated assessment tracker.

Europe Review Pathway

Plenty Of Action On EU Accelerated Assessment Front

A number of companies have sought to convince the European Medicine Agency that their drug merits a fast-track regulatory review.

Europe Review Pathway

Rare Liver Disease Drug Contenders Among Latest EU Filings

Among the 13 new drug marketing applications that the European Medicines Agency has most recently accepted for review are two products that could become the first approved treatments for children with progressive familial intrahepatic cholestasis, a life-threatening disorder.

Drug Review Europe
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Company Information

  • Industry
  • Biotechnology
  • Pharmaceuticals
  • Other Names / Subsidiaries
    • Albireo AB
    • Biodel Inc.
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