EU regulator backs Eisai-Biogen Alzheimer’s drug
EU drugs regulator recommends approval of Leqembi for early Alzheimer's, pending European Commission acceptance, for specific patient group.
European committee takes a second look at Alzheimer's drug and now says it should be approved
A European regulatory committee now recommends approval of the Alzheimer’s treatment lecanemab a few months after rejecting the drug. Biogen said Thursday that the drug, known in the U.S. as Leqembi,
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 wins over European regulators on Alzheimer’s drug Leqembi
A key regulatory committee sided against the drug this summer. But an appeal from Eisai appears to have worked, teeing Leqembi up for authorization in a major market.
EMA recommends Leqembi for treatment of early Alzheimer’s disease
After re-examining its initial opinion, EMA’s human medicines committee, or CHMP, has recommended granting a marketing authorisation to Leqembi for treating mild cognitive impairment or mild dementia due to Alzheimer’s disease in patients who have only one or no copy of ApoE4,
Changing course, European regulators now say Alzheimer’s treatment Leqembi should be approved
Reversing an earlier decision, European regulators recommended that an Alzheimer’s therapy from Eisai and Biogen should be approved.
European Watchdog Partially Approves New Alzheimer's Drug
Europe's medicines watchdog on Thursday partially approved a marketing request for a long-awaited new treatment for Alzheimer's disease, reversing an earlier decision not to give it the green light.
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.
EU Reverses Course: Approval for Breakthrough Alzheimer's Drug Leqembi Recommended
The EU's drugs regulator has recommended approval for Leqembi, a treatment by Eisai and Biogen, for early Alzheimer's disease. This could position it as the EU’s first treatment for the condition. The decision follows a re-evaluation,
Biogen up 5% after EMA recommends Leqembi for early Alzheimer’s disease
EST Biogen (BIIB) up 5% after EMA recommends Leqembi for early Alzheimer’s disease Published first on TheFly – the ultimate
Ticker: Biogen Alzheimer’s drug gets second look in EU; Ford takes $165M hit on slow recall
A European regulatory committee now recommends approval of the Alzheimer’s treatment lecanemab a few months after rejecting ...
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EMA rethinks stance, committee now recommends Leqembi for Alzheimer’s disease
Following a re-evaluation, the EMA has recommended Eisai and Biogen’s Alzheimer’s therapy Leqembi for a subgroup of patients.
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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 ...