Biogen, Eisai Win CHMP Backing of Leqembi Alzheimer's Drug
21 hours ago · Japan's Eisai serves as the lead for Leqembi's development and regulatory submissions worldwide and co-commercializes the drug with Cambridge, Mass., biotechnology company Biogen.
European committee takes a second look at ... - Associated Press News
19 hours ago · The committee had said in July that concerns about the drug’s potential side effects outweigh the impact it has in slowing the fatal, mind-robbing disease. But Japanese drugmaker Eisai asked the committee to reconsider its decision. Eisai developed Leqembi and is co-marketing it with Cambridge, Massachusetts-based Biogen Inc.
Eisai Receives Positive Opinion from the CHMP in the European …
20 hours ago · TOKYO and CAMBRIDGE, Mass., Nov. 14, 2024 /PRNewswire/ -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge ...
Eisai and Biogen shared LEQEMBI study results at AAIC 2024 | Eisai …
Jul 30, 2024 · SOURCE Eisai Co., Ltd. Eisai and Biogen presented LEQEMBI findings from the Clarity AD Phase 3 study, showing significant reductions in cognitive decline and functional improvements.
New Alzheimer’s drug Leqembi is granted full FDA approval - NBC News
Jul 6, 2023 · Leqembi, from Japanese drugmaker Eisai and U.S.-based drugmaker Biogen, targets a type of protein in the brain called beta-amyloid, long thought by scientists to be one of the underlying causes...
Eisai Completes Submission of LEQEMBI® (lecanemab-irmb ... - Biogen
Apr 1, 2024 · Eisai serves as the lead for lecanemab’s development and regulatory submissions globally with both companies co-commercializing and co-promoting the product and Eisai having final decision-making authority.
FDA Approves LEQEMBI™ (lecanemab-irmb) Under the ... - Eisai …
Jan 7, 2023 · Using the recently published data from the large global confirmatory Phase 3 clinical trial, Clarity AD, Eisai will work quickly to file a Supplemental Biologics License Application (sBLA) to the FDA for approval under the traditional pathway. INDICATION.
EISAI and Biogen Inc. Announce U.S. FDA Grants Breakthrough …
Jun 23, 2021 · TOKYO and CAMBRIDGE, Mass, – Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Michel Vounatsos, “Biogen”) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for lecanemab (BAN2401), an investigational anti-amyloid beta (Aβ ...
LECANEMAB CONFIRMATORY PHASE 3 CLARITY AD STUDY MET ... - Eisai …
Sep 28, 2022 · eisai's news release lecanemab confirmatory phase 3 clarity ad study met primary endpoint, showing highly statistically significant reduction of clinical decline in large global clinical study of 1,795 participants with early alzheimer’s disease is posted.
EISAI AND BIOGEN INC. ANNOUNCE U.S. FDA GRANTS …
Jun 24, 2021 · Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Michel Vounatsos, “Biogen”) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for lecanemab (BAN2401), an investigational anti ...
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