Biogen has withdrawn the EU marketing authorization application (MAA) for Aduhelm (aducanumab) after learning it was unlikely to convince the European Medicines Agency to reverse its recommendation last year that the Alzheimer’s disease drug should not be approved for use in the EU.
Biogen Pulls EU Filing For Aduhelm But Stands By Alzheimer’s Drug
The marketing application was withdrawn before the European Medicines Agency had finished re-examining its earlier recommendation to reject the drug.

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EU-level joint clinical assessments conducted under the Health Technology Assessment Regulation need to be more flexible when it comes to evidence requirements, according to experts speaking at a gene and cell therapy conference.
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Both the EU Clinical Trials Regulation and the European Health Data Space Regulation have the potential to improve harmonization and be highly valuable for industry – but the importance of protecting company data will be paramount, a life sciences consultant says.
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