The regulatory journey to accelerated approval for Biogen, Inc. and Eisai Co., Ltd.’s Alzheimer’s drug Aduhelm (aducanumab-avwa) was circuitous – a destination briefly visited but one that reappeared on the horizon only as time ticked down on the application’s 7 June user fee goal date.
Aduhelm's Journey To Accelerated Approval: Finding Buried Treasure In Uncharted Waters
The Alzheimer’s drug’s regulatory voyage to accelerated approval was circuitous – a destination briefly visited but one that reappeared on the horizon only as time ticked down on the application’s user fee goal date.
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A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.
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Eisai is working on securing reimbursement across the EU for Leqembi now that the Alzheimer’s disease treatment has secured marketing approval from the European Commission.
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US CDC’s Advisory Committee on Immunization Practices voted for harmonized meningococcal vaccine recommendations, while hearing updates about Sanofi’s pending supplemental MedQuadfi indication, AstraZeneca’s FluMist self-administration launch plans, and Lyme disease