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Biogen, Eisai Alzheimer’s drug lecanemab fast tracked by FDA

pharmaphorum

DECEMBER 24, 2021

Biogen and Eisai head towards the end of the year with some much-needed good news in their Alzheimer’s programmes, as the FDA awards a fast-track designation to lecanemab, their follow-up to recently approved Aduhelm. The post Biogen, Eisai Alzheimer’s drug lecanemab fast tracked by FDA appeared first on.

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Exit Aduhelm, enter lecanemab. Biogen and Eisai have another go

pharmaphorum

MAY 10, 2022

With Aduhelm largely sidelined, Biogen and Eisai are hoping for a better fortunes with their next Alzheimer’s disease therapy lecanemab, which is now fully filed with the FDA. The post Exit Aduhelm, enter lecanemab. Biogen and Eisai have another go appeared first on.

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Roche’s Early Alzheimer’s Blood Test Gets FDA Breakthrough Device Designation

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APRIL 18, 2024

Previously, Roche secured an FDA breakthrough tag for another one of its Alzheimer’s blood tests that detects levels of pTau-181 and ApoE4 (apolipoprotein e4). However, the guidance doesn’t say whether it could serve as a study’s primary endpoint on its own.

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Biogen, Eisai Alzheimer’s drug lecanemab fast tracked by FDA

Exit Aduhelm, enter lecanemab. Biogen and Eisai have another go

Roche’s Early Alzheimer’s Blood Test Gets FDA Breakthrough Device Designation

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