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The EC requests CHMP to reassess new safety data that emerged after the positive opinion recommending the approval of BIIB/Eisai's Leqembi in the EU for early AD.
The European Commission has requested its medicines regulator to consider safety information on Eisai and Biogen's Alzheimer's drug Leqembi, the agency said on Friday.
TOKYO and CAMBRIDGE, Mass., Jan. 31, 2025 (GLOBE NEWSWIRE) -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, “Biogen”) announced today an update on the ongoing regulatory review of the Marketing Authorization Application for lecanemab as treatment for early AD (mild cognitive impairment due to Alzheimer's disease (AD) and mild AD) in the European Union.
Biogen (BIIB) has an impressive earnings surprise history and currently possesses the right combination of the two key ingredients for a likely beat in its next quarterly report.
The FDA's approval is based on simulation data from multiple studies showing that maintenance dosing with Biogen???s Leqembi every four weeks prolongs biomarker benefits.
Sage Therapeutics said on Monday that its board has unanimously rejected the takeover offer it received from Biogen.
The U.S. Food and Drug Administration has approved monthly maintenance dosing for Japan's Eisai and partner Biogen's Alzheimer's drug Leqembi, the companies said on Monday.
Once every four weeks maintenance dosing may be easier for patients and care partners to continue treatment Alzheimer's disease progression does not stop after plaque clearance; ongoing treatment with LEQEMBI can slow disease progression and prolong the benefits of therapy TOKYO and CAMBRIDGE, Mass., Jan. 26, 2025 (GLOBE NEWSWIRE) -- Eisai Co., Ltd.
Once every four weeks maintenance dosing may be easier for patients and care partners to continue treatment Alzheimer's disease progression does not stop after plaque clearance; ongoing treatment with LEQEMBI can slow disease progression and prolong the benefits of therapy TOKYO and CAMBRIDGE, Mass. , Jan. 26, 2025 /PRNewswire/ -- Eisai Co., Ltd.
BIIB's regulatory filings are supported by late-stage data, which show that treatment with a higher Spinraza dose improves motor function in infants with SMA.