European regulators green light new Alzheimer's drug after first rejecting it
European regulators initially said in July that the drug's benefits did not outweigh its risks.View on euronews ...
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 ...
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 ...
EU regulator reverses decision to block Alzheimer's drug lecanemab
The European Union's drugs regulator reversed its decision to block the Alzheimer's drug lecanemab, a treatment aimed at ...
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 ...
GlobalData on MSN17h
EMA committee rethinks stance and 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.
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 ...
Biogen's stock rises after E.U. regulator reverses negative view of Alzheimer's drug
Biogen Inc.'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 - ...
Yahoo18h
European watchdog partially approves new Alzheimer's drug
"After re-examining its initial opinion, the EMA... has recommended granting marketing authorisation to Leqembi (lecanemab) ...
precisionmedicineonline20h
EMA's CHMP Now Recommends Approval for Eisai, Biogen's Alzheimer's Drug Leqembi in Europe
The agency had previously recommended against marketing authorization for the Alzheimer's disease but reconsidered after a review.
ALZFORUM22h
Leqembi: Side Effects No Worse in Clinical Use Than They Were in Trial
In Japan, clinical use is climbing faster, with about 4,500 people now on the drug. ARIA rates in Japan are half those in the U.S., which was also the case in the Phase 3 Clarity trial. Meanwhile, use ...
TMCnet1d
FDA authorizes the first AI-driven MRI solution for safer Alzheimer's treatment
"Amyloid-lowering treatments represent an important advance in the treatment of Alzheimer's disease but they are associated ...