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 ...
ALZFORUM4h
Finally, Therapeutic Antibodies Start to Reduce Tangles
Most discontinued anti-tau antibodies (red) targeted tau’s N-terminus. Of the antibodies currently in trials (green), bepranemab and E2814 presented results at CTAD, while JJ-63733657/posdinemab and ...
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 ...
BioPharma Dive5h
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 ...
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 ...
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 ...
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 ...
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 ...
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Eisai wins orphan drug status for Lenvima for esophageal cancer
The U.S. FDA has granted orphan drug designation to Eisai's (OTCPK:ESALF) Lenvima (lenvatinib) for esophageal cancer. The ...
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 - ...
US Treasury Department says MetLife unit settles over Iran sanctions violations
The U.S. Treasury Department said on Thursday that New York-based insurer MetLife's unit, American Life Insurance Company, ...