The firm said Biogen partner Eisai’s request for the EMA’s CHMP to reexamine the MAA for lecanemab in amyloid-positive early Alzheimer’s disease has paid off with a positive recommendation that ...

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and (Nasdaq: BIIB, Corporate headquarters: Cambridge, ...

A European regulatory committee now recommends approval of the Alzheimer’s treatment lecanemab a few months after rejecting ...

A European regulatory committee now recommends approval of the Alzheimer’s treatment lecanemab a few months after rejecting ...

The CHMP renders a positive opinion recommending approval for BIIB and Eisai's Leqembi for treating 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 ...

The European Union's drugs regulator reversed its decision to block the Alzheimer's drug lecanemab, a treatment aimed at ...

BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) today announces that EMA's Committee for Medicinal Products for Human Use (CHMP) has issued ...

Europe's medicines watchdog on Thursday partially approved a marketing request for a long-awaited new treatment for Alzheimer ...

The first drug targeting the root cause of Alzheimer’s disease has been approved by the European Medicines Agency. Despite ...

Here we go again. With Aduhelm largely sidelined, Biogen and Eisai are hoping for a better fortunes with their next Alzheimer's disease therapy lecanemab, which is now fully filed with the FDA.

Eisai serves as the lead for lecanemab's development and regulatory submissions globally with both Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision ...