President Donald Trump sent letters July 31 to the CEOs of 17 major drug manufacturers doing business in the U.S., giving them 60 days to comply with his May 12 executive order (EO) on most-favored-nation (MFN) pricing. The EO appealed to drug companies to undertake MFN pricing voluntarily to end the freeloading in which other developed countries pay, on average, three times less than Americans are charged for the same medicines.
The U.S. FDA has cleared Actio Biosciences Inc.’s IND application and granted fast track designation to ABS-1230, an expected first-in-class, orally administered small-molecule KCNT1 inhibitor, for the treatment of KCNT1-related epilepsy.
The U.S. Federal Trade Commission announced a $14.6 million grant it received for an upgrade of its IT infrastructure. The same grant mechanism is leveraged by the Department of Justice, which is a clear sign that U.S. enforcement will be more vigorously enabled by sophisticated analytics going forward.
The news that Vinay Prasad has stepped down as CBER director at the U.S. FDA had some biotech stocks literally jumping in joy as the market opened July 30. Meanwhile, Prasad’s decisions regarding vaccine development, as well as actions by Makary and HHS Secretary Robert Kennedy, are coming under fire.
Radiopharm Theranostics Ltd. announced that the U.S. FDA has cleared the IND application for betabart (RV-01), its Lu177-B7H3 monoclonal antibody designed with strong affinity for the 4Ig isoform of B7-H3 that is highly expressed in tumors and not in healthy tissues.
Following a priority review, Apellis Pharmaceuticals Inc. received U.S. FDA approval of a supplemental NDA making pegcetacoplan the second marketed treatment for complement 3 glomerulopathy and the first for primary immune complex membranoproliferative glomerulonephritis.
The ink is barely dry on the draft Medicare physician fee schedule for 2026, but three cardiology societies blasted the draft for cutting rates for left atrial appendage closure procedures – a move they said needlessly endangers patients.
Boston Scientific Corp. received CE mark certification under the Medical Device Regulation for its Intracept intraosseous nerve ablation system, bringing another treatment option to patients with chronic pain.
Understanding neurological disease requires several things, including a clear view of the connectome, and the U.S. National Institutes of Health may have a solution in the form of a new MRI system that allows the user to examine neural connections at the mesoscopic and microscopic scales.
Sarepta Therapeutics Inc.’s adventure with the Duchenne muscular dystrophy (DMD) AAV-based gene therapy Elevidys (delandistrogene moxeparvovec) continued as the firm said it would restart shipments of the compound for ambulatory patients “imminently,” with the U.S. FDA’s blessing.
RSS
