The recent emphasis on eliminating animal studies for preclinical studies of U.S. FDA-regulated products amplifies a long-standing concern, but the U.S. Government Accountability Office raised the question of whether organ-on-a-chip methods are ready to fill the gap.
Fujirebio Diagnostics Inc.’s Alzheimer’s disease assay received the U.S. FDA’s first clearance for a blood test for the debilitating neurodegenerative disease. Fujirebio’s Lumipulse G pTau217/ß-Amyloid 1-42 plasma ratio is indicated for the early detection of amyloid plaques associated with Alzheimer’s disease in symptomatic individuals aged 55 years and older.
Innovative Health LLC, of Scottsdale, Ariz., obtained a jury verdict of $147 million against Johnson & Johnson’s Biosense Webster unit for practices that thwarted the use of less costly reprocessed medical devices.
The U.S. Department of Justice said the CEO of Spinefrontier Inc., Kingsley Chin, entered a guilty plea in connection with allegations that he made false statements about payments made to surgeons for consulting work the physicians did not perform.
Using a customized gene editing therapy, researchers at the Children’s Hospital of Philadelphia have reported success in treating an infant with a severe metabolic disorder. Kiran Musunuru, Barry J. Gertz Professor for Translational Research in the University of Pennsylvania’s Perelman School of Medicine, presented the case at the American Society of Gene and Cell Therapy’s 2025 annual meeting. The case study was simultaneously published in The New England Journal of Medicine.
The U.S. FDA approved 20 drugs for market in April, slightly down from 22 in March, 16 in February and 12 in January. This brings the total number of FDA approvals for the first four months of 2025 to 70, a decrease from 77 in the same period last year but higher than the 50 drugs approved during the first four months of 2023 and 48 in 2022. Despite the decrease from last year, the 2025 total remains the second-highest in BioWorld’s records for this time frame.
Five years after the COVID-19 pandemic gripped the world, the U.S. FDA is moving away from annual routine boosters for all children and adults. Instead of that one-size-fits-all regulatory framework by which it has granted broad COVID-19 vaccine marketing authorization for all Americans older than 6 months, the agency said it’s adopting a policy akin to that followed in Europe, which now restricts the vaccines to older adults and those at high risk for severe disease.
The U.S. Department of Health and Human Services (HHS) put biopharma companies on notice May 20: It’s time to commit to reducing prescription drug prices to reflect most-favored-nation (MFN) pricing in accordance with President Donald Trump’s May 12 executive order. HHS said it expects manufacturers to commit to aligning their U.S. prices for all brand products across all markets that don’t currently have generic or biosimilar competition with the lowest price of a set of economic peer countries.
Suzhou Sanegene Bio Inc. has gained clinical trial approval in China for SGB-3383 for the treatment of complement-mediated kidney diseases, including IgA nephropathy, C3 glomerulopathy, immune complex-mediated membranoproliferative glomerulonephritis and atypical hemolytic uremic syndrome.
Repair Biotechnologies Inc.’s REP-0003 has been awarded orphan drug designation by the FDA for the treatment of homozygous familial hypercholesterolemia (HoFH).
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