The European Union's drugs regulator reversed its decision to block the Alzheimer's drug lecanemab, a treatment aimed at ...
Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and (Nasdaq: BIIB, Corporate headquarters: Cambridge, ...
The first drug targeting the root cause of Alzheimer’s disease has been approved by the European Medicines Agency. Despite ...
BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) today announces that EMA's Committee for Medicinal Products for Human Use (CHMP) has issued a positive recommendation regarding BioArctic's partner Eisai ...
The European Medicines Agency re-examined clinical data of a subset of patients with one or no copies of the APOE4 gene ...
Eisai Co., Ltd. (ESALF.PK) and Biogen Inc. (BIIB) announced a positive opinion has been received from the Committee for Medicinal ...
Eisai (ESAIY) and Biogen (BIIB) announced that a positive opinion has been received from the Committee for Medicinal Products for Human Use of ...
Anti-amyloid antibodies lecanemab and donanemab are in clinical use now, but that does not mean research on them has stopped. At the Clinical Trials on Alzheimer’s Disease conference, held October ...
The CHMP recommendation for the European Commission to approve lecanemab follows Eisai's request for a re-examination of the CHMP's earlier negative recommendation. A decision from the European ...
A European regulatory committee now recommends approval of the Alzheimer’s treatment lecanemab a few months after rejecting ...
In accordance with European Medicines Agency regulatory process, the European Commission is expected to make a final decision on the marketing authorization application (MAA) of lecanemab based on the ...
I am proposing that all companies currently engaged in developing biosimilars join hands with their regulatory and scientific ...