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Alzheimer's, Eisai 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.
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.
Biogen’s stock rises after E.U. regulator reverses negative view of Alzheimer’s drug
Biogen’s stock rose 1% Thursday, after Europe’s pharmaceutical regulator issued a positive opinion on the Alzheimer’s disease drug that the company developed with Japanese partner Eisai — reversing an earlier decision not to approve the drug.
FiercePharma
20h
Eisai sunsets development, access program for withdrawn obesity med in Dravet syndrome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 ...
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.
4d
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 ...
GlobalData on MSN
20h
How decentralisation can fill the gaps in Alzheimer’s research
Alzheimer’s trials face the unique challenge of studying participants with cognitive decline, amid a move towards digital ...
FiercePharma
3d
EU regulators endorse meds from BMS, J&J, Eisai and more—plus a clutch of biosims
Now, it's up to the European Commission to confirm those potential green lights in the coming weeks and months.
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Related topics
European Union
Alzheimer's disease
Biogen
Leqembi
Committee for Medicinal Products for Human Use
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