Biogen, Sarepta Quick Drug Approvals Show FDA Gaps, Report Says
Approvals for drugs from Biogen Inc. and Sarepta Therapeutics Inc. show flaws in the process US drug regulators use to speed ...
Sarepta, Biogen drugs with accelerated approval under fire in FDA report
A report from the U.S. FDA's Office of Inspector General is calling into question the thoroughness of the agency's ...
BioPharma Dive7d
Biogen’s ‘cold and calculated’ offer to buy Sage receives a mixed reaction on Wall Street
Analysts say the deal, which would give Biogen full control over the drug Zurzuvae, could be a smart financial move. Yet it's ...
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Sage sues Biogen after unsolicited takeover bid
Meanwhile, Sage reported failed phase 2 trials of dalzanemdor in Alzheimer's, Parkinson's, and Huntington's disease, and ...
Biogen Sued by Neuroscience Company Sage After Buyout Offer (1)
Sage Therapeutics Inc. sued Biogen Inc. on Friday, a week after the biotech giant made an unsolicited offer to acquire the ...
BioPharma Dive5d
At JPM, Biogen CEO tries to take down the deal temperature
While Biogen has made an opportunistic bid for partner Sage, its top executive seemed to play down the urgency for his ...
Sage Therapeutics: Biogen's Unsolicited Bid Is Best Step Forward For Shareholders
Sage Therapeutics' financials indicate a need for additional funding in 2025, risking dilution and further financial ...
Biogen lays out three FDA decisions that could ramp up Alzheimer's drug launch
Since its approval in 2023, the Alzheimer's disease drug made by Biogen Inc. and Eisai has seen a lackluster launch. However, Biogen CEO Chris Viehbacher said on Tuesday that there are a “number of ...
Biogen Beats Humana's RICO Suit Over MS Drug Scheme on Appeal
Humana Inc. fell short of pleading standards in its racketeering lawsuit against Biogen Inc. over its allegedly fraudulent ...
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Biogen, already a Sage partner and equity owner, offers to buy the rest of the neuro biotech
A yearslong partner of neuroscience player Sage, Biogen already owns 10.2% of the Cambridge, Massachusetts-based biotech, ...
Alzheimer’s drugs eyed as next big obesity-like opportunity
Investors seeking the next obesity-like market opportunity will be closely watching developments related to treatments for ...
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FDA To Review Under the Skin Weekly Autoinjector For Biogen/Eisai's Alzheimer's Drug Leqembi
A Prescription Drug User Fee Act (PDUFA) action date is August 31, 2025. The BLA is based on data from the Clarity AD (Study ...