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 ...
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 ...
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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Inspector General Questions FDA’s Accelerated Approval for Biogen, Sarepta Drugs
An OIG report zeroed in on what it said were three particularly problematic accelerated approvals: Biogen’s Aduhelm, ...
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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 ...
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FDA beats EMA to most approved new drugs in 2024
The US Food and Drug Administration (FDA) has narrowly beaten the European Medicines Agency (EMA) to the most approved drugs ...
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 ...
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Watchdog flags flaws in FDA's fast-track drug approvals
The OIG report points to gaps in documentation and decision-making transparency, particularly in the case of Aduhelm, where FDA records indicated only 13 meetings with Biogen, but congressional ...
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Government watchdog recommends tweaks to FDA accelerated approval program
The FDA established its accelerated approval program in 1992 to allow drugs to reach the market quickly for life-threatening ...
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Biogen, Sarepta Quick Drug Approvals Show FDA Gaps, Report Says
(Bloomberg) -- Approvals for drugs from Biogen Inc. and Sarepta Therapeutics Inc. show flaws in the process US drug regulators use to speed approval for drugs to fill unmet needs, federal ...