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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
9h
Eisai sunsets development, access program for withdrawn obesity med in Dravet syndrome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 ...
BioWorld
3d
Eisai wins on appeal: CHMP recommends Leqembi for Alzheimer’s
That follows an appeal by
Eisai
Co. Ltd. and a re-examination of the data, after details relating to 274 patients with two copies of the ApoE4 gene were removed from the file.
GlobalData on MSN
10d
Eisai lowers Leqembi revenue forecast after rocky entry to market
Leqembi is approved for Alzheimer’s patients in multiple territories, but questions remain over its cost-effectiveness.
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 ...
Yahoo Finance
8h
How decentralisation can fill the gaps in Alzheimer’s research
In a new era of Alzheimer’s disease research, the emergence of blockbuster therapies like Eli Lilly’s Kisunla (donanemab) and ...
3d
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
Biogen
European Union
Leqembi
Alzheimer's disease
Committee for Medicinal Products for Human Use
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