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 ...
BioSpace2d
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, ...
FiercePharma1d
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 ...
Becker's Hospital Review2d
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 ...
BioPharma Dive2d
Federal watchdog cites concerns with FDA’s accelerated approval process
The review, which was spurred by controversy over the FDA's Aduhelm approval, recommends two main changes in agency ...
BioSpace2d
Dispatches From JPM, Biogen’s Sage Buyout Offer, Pfizer’s Obesity Play, More
J&J, GSK, Eli Lilly and others struck high-value transactions in the early days of biopharma’s annual kickoff conference.
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After 2 Deaths, Philips Recalls Software That Mishandled Some EKG Readings
Another 109 people reported injuries after using the remote cardiac monitoring software, Modern Healthcare reported. Other pharmaceutical and tech news is on the FDA's drug approval system and a rapid ...
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OIG Recommends Changes in FDA Accelerated Approval After Flagging Concerns With Aduhelm, Other Drugs
The OIG recommended that the FDA define factors that would trigger an application's review by an agency council, which the agency disagreed with.
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Sarepta, Biogen drugs with accelerated approval under fire in FDA report
The Sarepta and Biogen therapies mentioned are, respectively, Exondys 51 (eteplirsen) and Aduhelm (aducanumab). They are used for Duchenne muscular dystrophy and Alzheimer's disease. The FDA's ...
Mint2d
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 ...