PR Newswire

The newsfeed available here is provided by our content partner PR Newswire. This is one of the most important and widest-reaching press services, providing news, press releases and multimedia content to the media, journalists and the public.
The NewsWire Hub ("X-Billboard") currently comprises four of the most important international news sources and is supplemented by a stock market information service. The individual newswire services complement each other and provide a complementary range of information, more than three quarters of the official news sources on which editors worldwide base their stock market reporting. Your advantage: You will find everything here in one overview. You can navigate to the individual sections using the control elements. In the terminal view, you can carry out individual searches at company level.
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PR Newswire is an important news source that can be accessed via the X-Billboard. It is part of the Newswire Hub, which bundles important international news sources for stock market participants in one central location. If you want to get a quick overview, you can easily scroll through the headlines. If you want to look at the news in more detail, you can use the detailed views of the info cards to directly access the respective news item and other analysis tools.
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State: 17.08.2024 | 11PM
Thu, 14.11.2024       Biogen
US09062X1037

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, Massachusetts, CEO: Christopher A. Viehbacher, "Biogen") announced today a positive opinion has been received from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommending approval of the amyloid-beta (Aβ) monoclonal antibody lecanemab as a treatment of adult patients with a clinical diagnosis of mild cognitive impairment and mild dementia due to Alzheimer's disease (Early Alzheimer's disease)  who are apolipoprotein E ε4 (ApoE ε4)* non-carriers or heterozygotes with confirmed amyloid pathology.1 Eisai had requested a re-examination of the prior negative opinion adopted by the CHMP in July 2024. In accordance with European Medicines Agency regulatory process, the European Commission is expected to make a final decision on the marketing authorization application (MAA) of lecanemab based on the CHMP recommendation within 67 days of receipt of CHMP opinion.2 

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