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FDA instructs Eisai and Biogen to seek Fast Track designation for Alzheimer drug lecanemab's subcutaneous formulation, impacting regulatory submission plans and causing potential delays; decision expected within 60 days of March 2024 submission
Published: April 05, 2024 by Psychiatric Times
European Medicines Agency delays decision on Biogen and Eisai's Alzheimer's drug lecanemab due to procedural implications from an EU court ruling; the delay is unrelated to the marketing authorization application submitted for lecanemab
Published: March 26, 2024 by Zack's Commentary
Eisai obtains marketing authorization from Japan's Ministry of Health for injectable form of antiepileptic drug Fycompa; the new formulation provides an alternative therapy for patients unable to take the drug orally.
Published: January 23, 2024 by PharmaBiz
China approves Eisai's Leqembi injectable to treat minor dementia and cognitive dysfunction triggered by Alzheimer’s; China also approves Gilead's Descovy tablet for pre-exposure prophylaxis to lower the risk of HIV infection
Published: January 16, 2024 by ForeignAffairs.co.nz
Eisai and Biogen's Alzheimer's treatment, Leqembi, gets approval from Japan's health ministry, making Japan the second country after the US to permit its use; the drug helps reduce the progression of mild cognitive impairment and mild dementia
Published: September 27, 2023 by Business Day

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