In an about-face, Sarepta Therapeutics Inc. said it would “voluntarily and temporarily” pause all shipments of Duchenne muscular dystrophy gene therapy Elevidys (delandistrogene moxeparvovec) in the U.S. The move comes only a few days after the firm publicly declined a U.S. FDA request to halt shipping of the therapy in the wake of a third patient death, this one linked to a gene therapy using the same adeno-associated virus (AAV) vector as Elevidys.
There are a raft of problems the U.S. FDA wants resolved before Replimune Group Inc.’s BLA for RP-1 (vusolimogene oderparepvec) with nivolumab to treat advanced melanoma goes any further, all of which the company said are a surprise.
The U.S. FDA expanded the approval for use of Boston Scientific Corp.’s Watchman Flx and Watchman Flx Pro left atrial appendage closure (LAAC) devices to include post-ablation patients, bringing good news to the company as it preps for its second quarter earnings report on July 23.
Australia’s Therapeutic Goods Administration proposed to adopt a 2021 EU guideline on quality documentation for drugs used with medical devices including co-packaged products, a demonstration of the impact of EU regulations on Australia’s own regulatory approach.
Palmetto GBA of Columbia, S.C., issued a draft local coverage determination that provides coverage for biomarker testing to stratify a patient’s risk associated with ductal carcinoma in situ.
Despite Health and Human Services Secretary Robert Kennedy’s oft-repeated vow to rid the FDA of industry influence, FDA Commissioner Marty Makary announced George Tidmarsh, an industry veteran, will be the next director of the agency’s Center for Drug Evaluation and Research (CDER).
Sarepta Therapeutics Inc. is declining a U.S. FDA request to voluntarily halt shipping its gene therapy, Elevidys (delandistrogene moxeparvovec), in the U.S. On July 18, Sarepta said had it received “an informal request” from the FDA to stop the shipments following a third patient’s death, tied to the gene therapy SRP-9004, which uses the same vector as Elevidys.
The U.S. False Claims Act (FCA) is not the only statute governing the submission of false claims to federal agencies thanks to the more than 30 states with their own versions of the FCA. However, the federal government is providing states with more incentives to amplify their FCA-related activities, a development that raises the stakes for companies in the life sciences.
The Australian government has awarded nearly AU$100 million (US$64.65 million) in grant funding to three biopharma/med-tech incubators to support emerging Australian biopharma and med-tech startups.
The U.S. FDA approved 22 drugs in June, tying with March for the highest number of approvals and a jump from 15 approvals in May. The FDA approved 107 drugs in the first half (H1) of 2025, making it the third-highest total for this period in BioWorld’s records, trailing 118 approvals in 2024 and 108 in 2020.
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