Seeking Alpha23d
Biogen, Eisai say injectable Alzheimer’s therapy granted FDA review
Biogen (NASDAQ:BIIB) and Eisai (OTCPK:ESALF) (OTCPK:ESAIY) announced that the U.S. Food and Drug Administration (FDA) accepted a marketing application for an injectable version of their Alzheimer ...
pharmaphorum5d
Biogen exits biosimilar JV with Samsung, raising $2.3bn
The cash injection comes as Biogen has been hit hard by the stalled rollout of its Alzheimer's disease drug Aduhelm (aducanumab), with Stat reporting earlier this month that the company is ...
FiercePharma10d
No deal: Sage rejects Biogen's buyout offer, scouts for strategic alternatives
After receiving and considering an "unsolicited" buyout offer from partner Biogen, Sage Therapeutics is kicking the tires on ...
Nasdaq23d
Eisai and Biogen Announce FDA Acceptance of Lecanemab Subcutaneous Autoinjector Application for Alzheimer's Disease Treatment
Biogen does not undertake any obligation to publicly update any forward-looking statements. LEQEMBI (lecanemab-irmb) injection, for intravenous use [package insert]. Nutley, NJ: Eisai Inc ...
PMLiVE22d
Biogen/Eisai announce FDA BLA acceptance for injectable Alzheimer’s drug
Biogen and Eisai have announced that the US Food and Drug ... maintenance dosing in patients who have completed the bi-weekly IV initiation phase, with the injection process expected to take 15 ...
The Business Journals10d
Sage rejects Biogen’s buyout offer, but says it's open to deals
The proposed merger of the two Cambridge drugmakers is off, but Sage says it's open to "strategic alternatives" — including a sale. Sage Therapeutics Inc. is looking for a deal — but it’s ...
Benzinga.com23d
FDA To Review Under the Skin Weekly Autoinjector For Biogen/Eisai's Alzheimer's Drug Leqembi
The injection process is expected to take ... s development and regulatory submissions globally. Eisai and Biogen co-commercialize and co-promote the product, and Eisai has the final decision ...
Seeking Alpha6d
Biogen, Eisai Alzheimer’s drug review delayed in EU
Biogen (NASDAQ:BIIB) and Eisai (OTCPK:ESALF) are expected to face another delay in launching their new Alzheimer's drug, lecanemab, in the EU after the European Commission on Friday asked the ...
pharmaphorum23d
FDA sets August date for subcutaneous Leqembi decision
The FDA has started its review of a subcutaneous injection formulation of Eisai and Biogen's Alzheimer's drug Leqembi that could allow patients to receive maintenance doses at home, rather than in ...
Bloomberg L.P.6d
EU to Weigh New Safety Data on Biogen, Eisai Alzheimer’s Drug
European Union regulators will review new information relating to the safety of Eisai Co.’s and Biogen Inc.’s medicine for Alzheimer’s disease, providing a response after a meeting next month.
The Boston Globe27d
Alzheimer’s drugs eyed as next big obesity-like opportunity
Biogen shares soared 44 percent on a single ... The company is also evaluating a follow-on drug, known as remternetug, via injection as well as infusion. The late-stage trial will assess the ...