Jan 15, 2025 · An OIG report zeroed in on what it said were three particularly problematic accelerated approvals: Biogen’s Aduhelm, Sarepta’s Exondys and Covis’ Makena.

Jan 14, 2025 · 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...

Jan 14, 2025 · 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...

Jan 14, 2025 · Biogen’s Aduhelm, Sarepta’s Exondys 51, along with Covis Pharma’s Makena were all cleared quickly by the US Food and Drug Administration despite weak evidence and disagreements among reviewers, according to the report Tuesday from Department of Health and Human Services’ Office of Inspector General.

2 days ago · Executives from Sarepta believe that the updated data from EMBARK now validate the benefits they had observed in smaller clinical trials. Louise Rodino-Klapac, Sarepta's CSO and head of R&D, described the top-line results presented Monday as "extremely clean, powerful" data. "I was extremely pleased with this data," she said during the ...

Jan 15, 2025 · 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 ...

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...

2 days ago · Sarepta Therapeutics, Inc. (SRPT) Q3 2024 Earnings Call Transcript Sarepta, Biogen drugs with accelerated approval under fire in FDA report Sarepta preliminary Q4 revenue beats, but full year just ...

Nov 7, 2024 · Sarepta Therapeutics is giving up on an experimental drug for Duchenne muscular dystrophy as sales rocket for its approved gene therapy for the disease. The decision to discontinue SRP-5051 was based on several factors, company executives told analysts on a conference call Wednesday.

Dec 4, 2024 · Sarepta pulled off the massive Arrowhead tie-up amid an increasingly competitive neuromuscular space. The BMO group pointed to Novartis’ $1.1 billion acquisition of Kate Therapeutics in the same week and Sanofi’s May licensing agreement with Fulcrum Therapeutics that could be worth over $1 billion.