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.
While U.S. government cost-cutting seems to be the Trump administration’s priority that consumes all others, some Republican senators are pushing back – at least when it comes to the NIH. Fourteen senators wrote to Russell Vought, head of the White House Office of Management and Budget, to voice their concerns about the administration’s slow disbursement rate of the NIH’s fiscal 2025 funds.
Pharmaceutical exports from the EU to the U.S. are facing a leap in tariffs from zero duty to 15%, following the trade deal between EU Commission President Ursula von der Leyen and U.S. President Donald Trump sealed in Scotland July 27.
With more-than-satisfying phase III data in hand, Minneapolis-based Celcuity Inc. is eyeing an NDA submission in the fourth quarter of this year for gedatolisib (geda) in breast cancer. Shares of the company (NASDAQ:CELC) closed July 28 at $36.79, up $23.02, or 167%, after Wall Street learned of stellar top-line results from the PIK3CA wild-type cohort of the phase III Viktoria-1 trial.
Janssen Pharmaceutical’s loss in a False Claims Act (FCA) case for the company’s HIV treatments resulted in judgments of roughly $1.6 billion – an outcome the company appealed to the Court of Appeals for the Third Circuit.
Cryofocus Medtech (Shanghai) Co. Ltd. received U.S. FDA breakthrough device designation on July 24 for its cryoablation system for asthma. The Chinese med-tech’s stock (HKEX:6922) rose near 20% over two consecutive days on the Hong Kong Stock Exchange with the news, increasing from HK$5.00 ($.64) July 23 to HK$5.98 nearing the close of trading on July 25.
The first filing in the name of Grand Rapids, Mich.-headquartered Corium Innovations Inc. confirms the company formerly known as Corium Pharma Solutions Inc. is developing treatments for multiple sclerosis and ulcerative colitis that employ its proprietary Corplex transdermal patch technology.
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