“For us geeks, this is the trailer. This isn’t the movie,” John Stanford told BioWorld as he reacted to the prices the U.S. Centers for Medicare & Medicaid Services announced today for the drugs in the first round of negotiations under the Inflation Reduction Act. While the prices are generally in line with what was expected, Stanford said they raise more questions than answers. The rationale for those prices, which must be released by March 1, will be part 1 of the movie, said Stanford, the executive director of Incubate, a coalition of investors in the early stage life sciences sector. Part 2 will premiere when the drugs are selected for the next round of negotiations.

FDA greenlights Niktimvo in GVHD from Syndax, Incyte

Syndax Pharmaceuticals Inc. and Incyte Corp. scored U.S. FDA approval – well ahead of the Aug. 29 PDUFA date – of Niktimvo (axatilimab), an anti-CSF-1R antibody for the treatment of chronic graft-vs.-host disease (GVHD) after failure of at least two prior lines of systemic therapy in adult and pediatric patients weighing at least 40 kg (88.2 lbs.). Syndax CEO Michael Metzger said during a conference call with investors that the product, his firm’s first approved asset, will launch in the fourth quarter of this year or early 2025. Pricing will be disclosed later, as Niktimvo goes up against the kinase inhibitor Rezurock (belumosudil) for third-line GVHD from Kadmon Holdings Inc., acquired by Sanofi SA in September 2021.

Siga’s antiviral stumbles in mpox study as Bavarian Nordic ramps up

As mpox has now been found in the EU, the race for an effective vaccine has accelerated. The U.S. NIH just released top-line results from a preliminary analysis of a placebo-controlled study of the antiviral tecovirimat showing it missed the primary endpoint of statistically significant improvement in time to lesion resolution in the Democratic Republic of the Congo. The study of Siga Technologies Inc.’s vaccine was not a registration study conducted under a U.S. FDA NDA. The company’s stock (NASDAQ:SIGA) had lost about a quarter of its market value at midday, as shares were trading 26.4% downward at $8.80 each. Bavarian Nordic A/S said it received a new order from the European Health Emergency Preparedness and Response Authority for the company’s MVA-BN vaccine, approved by the FDA and the EMA as a vaccine for mpox.

Wegovy available in Australia; hefty price likely to deter use

In the wake of shortages for Novo Nordisk A/S’ Ozempic (semaglutide), Australia’s Therapeutic Goods Administration has announced that Wegovy, which has the same active ingredient, is now available in Australia and is advising prescribers to stop prescribing Ozempic off label for weight loss. Fake versions of Novo’s 1-mg Ozempic prefilled pens are sounding alarms in Europe amid an ongoing shortage of the company’s semaglutide products resulting from demand in the weight-management space, BioWorld earlier reported.

Implantable device automatically reverses opioid overdoses

In response to the continuing opioid epidemic, researchers at the Massachusetts Institute of Technology and Brigham and Women’s Hospital developed a small implantable device that monitors heart rate, respiration and other vital signs indicative of an overdose, then automatically releases a dose of naloxone. Designed for people who have already survived an overdose or have other significant risk factors, the implant reverses the effects of an overdose even for very rapid-acting opioids like fentanyl, a study published in Device demonstrated.

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