Inspector General Questions FDA’s Accelerated Approval for Biogen ...
2 days ago · In a 32-page report, the Office of the Inspector General (OIG) flagged three drugs in particular—Biogen’s Alzheimer’s disease antibody Aduhelm (aducanumab), Sarepta’s Duchenne muscular dystrophy therapy Exondys (eteplirsen) and Covis Pharma’s Makena (hydroxyprogesterone caproate)—for which it said the accelerated approval process ...
OIG says FDA accelerated approval program needs adjustments
22 hours ago · Early last year, Biogen pulled the plug on the treatment. Biogen FDA Office of Inspector General (OIG) Department of Health and Human Services (HHS) accelerated approval Sarepta Makena Exondys 51 ...
Biogen, Sarepta Quick Drug Approvals Show FDA Gaps, Report …
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 watchdogs said in a report.
Sarepta, Biogen drugs with accelerated approval under fire in …
2 days ago · 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.
Sarepta, Biogen drugs with accelerated approval under fire in …
A report from the U.S. FDA's Office of Inspector General is calling into question the thoroughness of the agency's accelerated approval process, and is using treatments from Sarepta Therapeutics (NASDAQ:SRPT) and Biogen (NASDAQ:BIIB) as examples.
Sarepta Therapeutics Announces FDA Approval of ELEVIDYS, the …
Jun 22, 2023 · CAMBRIDGE, Mass. -- (BUSINESS WIRE)--Jun. 22, 2023-- Sarepta Therapeutics, Inc. (NASDAQ: SRPT), the leader in precision genetic medicine for rare diseases, today announced U.S. Food and Drug Administration (FDA) accelerated approval of ELEVIDYS (delandistrogene moxeparvovec-rokl), an adeno-associated virus …
Biogen's Alzheimer's drug gets caught in Sarepta's spotlight
Dec 13, 2019 · Biogen's experimental treatment for Alzheimer's disease is back in the spotlight, this time because a different drug that has also been met with skepticism just received an unexpected approval. On Thursday afternoon, the Food and Drug Administration announced it had cleared Sarepta Therapeutics' Vyondys 53 for Duchenne muscular dystrophy.
Sarepta preps $1.2B war chest for DMD gene therapy - Fierce …
Nov 3, 2022 · Sprinting in an “urgent race against a brutal disease,” just like patients, Sarepta has raised a $1.2 billion war chest to prepare for a launch of the Duchenne muscular dystrophy gene therapy...
With spotlight on FDA, Congress weighs reforms to accelerated …
May 10, 2022 · Approval of Biogen's Aduhelm, as well as drugmaker delays in completing confirmatory trials, have highlighted flaws in the program, pushing lawmakers to consider changes.
FDA Drug Approval Process Under Scrutiny: Insights from Biogen …
The recent approvals of drugs from Biogen and Sarepta have sparked significant debate regarding the Federal Drug Administration's (FDA) regulatory processes, raising questions about the thoroughness and consistency of drug reviews.
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