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.
Med-tech companies raised $8.13 billion in the second quarter of 2025, a modest dip from the $8.32 billion recorded in Q1. While the quarterly total marks a continued improvement over 2023’s lower figures, it still lags behind pre-pandemic peaks and the $22.87 billion raised in 2Q20. Compared to 2Q24’s $7.49 billion, this year’s figure reflects a slight year-over-year gain.
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.
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.
Total venture capital funding in U.K. biotech was £1.23 billion (US$1.64 billion) in the first half of 2025, almost matching the 2023 total of $1.66 billion and looking to be in position to equal the 2024 12-month total of $2.8 billion.
With reduced sales and operating expectations for the rest of the year, Novo Nordisk A/S is on the receiving end of a huge stock drop. For a big pharma, where the stock drops are usually more modest, the shares (NASDAQ:NVO) fell off a cliff on July 29, closing 21.8% downward to $53.93 each, the lowest price per share in the past 12 months. Lower U.S. sales of semaglutide blockbusters Wegovy and Ozempic for treating obesity and diabetes are at the heart of the plunge. In May, the Danish company had expected 13% to 21% sales growth but now is looking at only 8% to 14%.
PTC Therapeutics Inc. will be launching its oral phenylketonuria therapy, Sephience (sepiapterin) in both the U.S. and Europe this summer, following the U.S. FDA approval just ahead of its July 29 PDUFA date. Sephience previously gained marketing authorization by the European Commission, roughly three months after a thumbs up from the EMA’s Committee for Medicinal Products for Human Use.
An advisory committee for the U.S. Centers for Medicare & Medicaid Services endorsed a series of patient- and clinician-reported outcomes that might not be reflected in the evidentiary bases for currently available technologies. This development suggests some manufacturers will have to conduct new studies of their devices in order to sustain Medicare coverage.
The U.S. FDA posted an update on the early alert for the Novum IQ infusion pump by Baxter International Inc., which includes a suggestion that the administration set be moved half an inch farther down the line before doubling the bolus infusion rate.
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