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Eisai, Alzheimer's and Biogen
EU regulator backs Eisai-Biogen Alzheimer's drug after initial rejection
The European Union's drugs regulator on Thursday recommended approval of Eisai and Biogen's Leqembi for some patients with early Alzheimer's disease, reversing its initial decision from four months ago.
EMA changes tune, endorses Eisai and Biogen's Leqembi in restricted Alzheimer's population
Upon reexamination, the European Medicines Agency has made a U-turn on Eisai and Biogen’s Alzheimer’s disease drug Leqembi. | Upon reexamination, the EMA has made a U-turn on Eisai and Biogen’s Alzheimer’s disease drug Leqembi.
Eisai dials back forecasts for Alzheimer's drug Leqembi
Longer-term, Eisai and Biogen are hoping for further evidence to support Leqembi from the phase 3 AHEAD 3-45 trial, which started in 2020 and is underway in Japan, the US, and Europe and is enrolling people ages 55-80 who have not been diagnosed with Alzheimer's or another form of dementia. Results are due in 2028.
FiercePharma
13h
Eisai sunsets development, access program for withdrawn obesity med in Dravet syndrome
In the wake of a market pull in obesity nearly five years ago, the other shoe has dropped for
Eisai
’s serotonin 2C receptor ...
BioSpace
10d
Eisai Cuts Fiscal 2024 Guidance for Biogen-Partnered Leqembi as Sales Disappoint Analysts
Leqembi’s sales continue to be underwhelming, according to analysts, who contend the companies’ Alzheimer’s disease therapy ...
3d
Biogen Partner Eisai Gets Positive CHMP Nod for Leqembi in Europe
The CHMP renders a positive opinion recommending approval for BIIB and Eisai's Leqembi for treating early Alzheimer's disease ...
3d
Eisai Gets Positive Opinion From CHMP In European Union For Lecanemab In Early Alzheimer's Disease
Eisai Co., Ltd. (ESALF.PK) and Biogen Inc. (BIIB) announced a positive opinion has been received from the Committee for Medicinal ...
devdiscourse
4d
EU Gives Green Light: Leqembi on the Verge of Alzheimer's Approval
The EU's drugs regulator recommends approval of Eisai and Biogen's Alzheimer's drug, Leqembi, for patients with early stages ...
4d
Eisai Receives Positive Opinion from the CHMP in the European Union for Lecanemab in Early Alzheimer's Disease
Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: ...
4d
Eisai receives positive CHMP opinion for Lecanemab in early Alzheimer’s disease
Eisai (ESAIY) and Biogen (BIIB) announced that a positive opinion has been received from the Committee for Medicinal Products for Human Use of ...
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Related topics
European Union
Alzheimer's disease
Biogen
Leqembi
Committee for Medicinal Products for Human Use
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