Eisai, Biogen and Leqembi

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.
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.
EU regulator backs Eisai-Biogen Alzheimer's drug after initial rejection
The European Union's drugs regulator on Thursday recommended approval for Eisai and Biogen's Leqembi in some patients with early Alzheimer's disease, nearly four months after it first rejected the treatment.
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 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.
EU drugs regulator recommends Alzheimer's drug from Eisai-Biogen
The European Union's drugs regulator on Thursday said it recommends approval of Eisai and Biogen's Leqembi in patients with early Alzheimer's disease, months after the agency first rejected the treatment.
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 of the disease. The approval is limited to those with certain genetic profiles.
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.
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.
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
FiercePharma2h
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.
STAT1h
Pharmalittle: We’re reading about an Alzheimer’s drug about-face, Bavarian Nordic’s views on Trump, and more
Reversing an earlier decision, European regulators recommended that the Alzheimer’s therapy Leqembi should be approved ...
devdiscourse23h
EU Backs Leqembi: A Breakthrough in Alzheimer's Treatment
The European Union's drugs regulator has recommended approval for Eisai and Biogen's Alzheimer's drug Leqembi. This marks a ...