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Aduhelm's Journey To Accelerated Approval: Finding Buried Treasure In Uncharted Waters

 
• By Sue Sutter

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.  

treasure map
X marks the spot of accelerated approval on Biogen's treasure map. • Source: Alamy

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.

US Food and Drug Administration review documents show that as early as December 2014, there was discussion with Biogen about...

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Sanofi Secures EU Fast-Track Status For ‘Game-Changing’ Sleeping Sickness Drug

 
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If approved, Sanofi’s acoziborole could become the first single-dose oral treatment for sleeping sickness.

EU 2025 Novel Drug Approvals See Conditional Authorizations Outpacing Previous Years

 
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Expedited Reviews For China-Originated Drugs Shift Back Home

 
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NDA User Fees Will Grow 8.6% Next Year As FDA Projects More Applications But Fewer Sponsor Meetings

 
• By Nielsen Hobbs and Derrick Gingery

The ups – and some downs – of the US FDA’s prescription, biosimilar, and generic user fees for FY 2026 are tabulated by the Pink Sheet.

EU 2025 Novel Drug Approvals See Conditional Authorizations Outpacing Previous Years

 
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New EU Drug Safety Rules Scrap Signal Detection Pilot, Boost Audit & Subcontracting Controls

 
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