It doesn’t happen often—in fact, hardly ever—that a company decides to stop studying a promising drug it’s developing and then a few months later asks the Food and Drug Administration (FDA) to consider approving it. But that’s exactly what occurred with aducanumab, an Alzheimer’s drug being developed by U.S. pharmaceutical company Biogen and its partner, Eisai, a Japanese pharma outfit.
Biogen Explains How Its Alzheimer’s Drug Went From Poor To Promising
Alice Park, Time
Fri, 12/06/2019 - 9:42am
Topics: drug administration fda japanese u.s this clinical trials san diego last march october on dec samantha budd haeberlein july concerned in march emerge dr stephen brown university biogen s fda aducanumab patients dr sharon cohen toronto memory program alzheimer&rsquo biogen march as budd haeberlein engage aria salloway promising people study studies company data dose risk genetic showed analysis mg/kg participants benefit cognitive doses mild treatment receive developing results compared early complete time side called effect doctors approved allowed brain detailed maximum highest led left moderate developed fact stop week researchers conference provide it’s minimize result inflammation received schedule change show placebo slow decline tests differently stopped presented ended company’s optimal month participated encouraging means panel enrolled
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04/9/2024 - 9:25 am | View Link - EU drug regulator does not refer to Eisai-Biogen Alzheimer's drug in meeting notes
The drug, sold as Leqembi in the United States has been under review in Europe since January 2023. It gained traditional approval in the United States last year and is also approved in other ...
03/22/2024 - 12:46 pm | View Link - EU regulator delays decision on Eisai-Biogen Alzheimer's drug
March 22 (Reuters) - The European Union's medicines regulator has delayed its decision on Eisai (4523.T), opens new tab and partner Biogen's (BIIB.O), opens new tab Alzheimer's disease drug that ...
03/22/2024 - 3:30 am | View Link - EU delays decision on Eisai-Biogen Alzheimer’s drug
The European Union's drug regulator has delayed its decision on Eisai (OTCPK:ESALF) (OTCPK:ESAIY) and partner Biogen's (NASDAQ:BIIB) breakthrough Alzheimer's therapy, Leqembi (lecanemab).
03/22/2024 - 2:50 am | View Link - EU drug regulator does not refer to Eisai-Biogen Alzheimer's drug in meeting notes
March 22 (Reuters) - The European Union's medicines regulator did not mention Eisai 4523.T and Biogen's BIIB.O Alzheimer's drug in its notes and recommendations on Friday. The European Medicines ...
03/22/2024 - 12:24 am | View Link - More
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