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Latest From Eisai Co., Ltd.

Finance Watch: $135m In Venture Capital Will Fund Amylyx’s Late-Stage ALS Drug

Private Company Edition: Amylyx will use its new cash to run a Phase III trial and submit applications seeking EU and Canadian approvals of AMX0035, but US filing plans based on prior Phase II/III data are less clear. Also, three VC firms raised new funds targeting biopharma and other investments.

Financing Innovation

Aduhelm Invades Senate Committee’s COVID-19 Hearing

Woodcock again defends the decision, saying Congress intended accelerated approval for those situations.

Politics Neurology

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.

Approvals Review Pathway

Pink Sheet Podcast: As Aduhelm Turns, Teva Sues Under CREATES Act, Neulasta Untitled Letter

Pink Sheet reporters and editors discuss another explanation of the FDA’s Aduhelm label, the first lawsuit attempting to force the sale of samples for generic development, and the agency questioning promotion of Amgen’s Neulasta.

Neurology Legal Issues
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