Biogen has withdrawn the EU marketing authorization application (MAA) for Aduhelm (aducanumab) after learning it was unlikely to convince the European Medicines Agency to reverse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The marketing application was withdrawn before the European Medicines Agency had finished re-examining its earlier recommendation to reject the drug.

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In a historic move for Africa, five products have been backed for approval via a pilot that tested a continental listing process.
Pharmaceutical companies are being encouraged to reach out to NICE in relation to its HTA Innovation Lab, which provides a sandbox environment in which the health technology assessment body can test new methods of evaluating “innovative and disruptive” therapies.
The weight management drug, Mysimba, continues to demonstrate a positive benefit-risk balance but the data available are not sufficient to fully determine the cardiovascular safety beyond 12 months. Meanwhile, Currax this month announced the publication of a peer-reviewed study of Mysimba that followed patients for over 4.7 years and found no evidence of excess cardiovascular risk.
Health technology assessment body NICE said it has taken on feedback about the implications of allowing higher cost-effectiveness thresholds for some medicines after senior health economists offered diverging views on its methods.
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One CDRH employee said the cuts already are having a major effect on morale.
Mass FDA layoffs on 1 April were designed to spare product reviewers, but still touched many who are critical to the application review process or drug development, which could mean fewer treatments are brought to the US market first.
Pharmaceutical companies are being encouraged to reach out to NICE in relation to its HTA Innovation Lab, which provides a sandbox environment in which the health technology assessment body can test new methods of evaluating “innovative and disruptive” therapies.