While inflation in the U.S. is hovering below 3%, increases in some FDA user fees for fiscal 2026 are tripling that rate. PDUFA fees for branded prescription drugs and biological products will see a 9% hike come Oct. 1, and the increase in MDUFA fees will more than double the inflation rate with a 7% hike across the board.
Regeneron Pharmaceuticals Inc. disclosed within a positive second-quarter earnings report that it had received a complete response letter (CRL) two days earlier from the U.S. FDA for its bispecific antibody, odronextamab, for relapsed/refractory follicular lymphoma following two or more lines of systemic therapy.
With the U.S. FDA’s approval of Lenz Therapeutics Inc.’s Vizz (aceclidine ophthalmic solution), there is a third eye drop on the market for treating presbyopia. Vizz, however, is the first aceclidine-based eye drop for adults.
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.
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.
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.
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.
Becoming the first approved treatment for chronic hand eczema in the U.S., Leo Pharma A/S’s Anzupgo (delgocitinib) received FDA clearance for an indication that affects 10% of adults worldwide. The cream, dosed at 20 mg/g and applied topically, will treat moderate to severe cases in those not responsive to, or unable to take, topical corticosteroids.
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.
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