“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 Aug. 15 for the 10 drugs selected for 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 as it should provide some insight into the price setting, said Stanford, the executive director of Incubate, a coalition of investors in the early stage life sciences sector.
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.
Wall Street promptly started speculating about the product’s odds in the graft-vs.-host disease (GVHD) marketplace shortly after 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 disease after failure of at least two prior lines of systemic therapy in adult and pediatric patients weighing at least 40 kg (88.2 lbs.).
Boehringer Ingelheim GmbH’s and Astrazeneca plc’s implementation of a $35 monthly U.S. price cap on inhalers for asthma and chronic obstructive pulmonary disease is adding to the pressure on Prasco Laboratories and GSK plc to follow suit with the pricing of an authorized generic of GSK’s Flovent (fluticasone propionate) inhaler.
The U.S. Court of Appeals for the Federal Circuit reinstated patent claims covering Allergan USA Inc.'s bowel treatment drug Viberzi (eluxadoline), reversing a lower court that had invalidated the claims for not meeting obviousness-type double patenting or written description requirements. However, the appellate court said the district court “can, and should, address any other grounds of invalidity raised … at trial that are adequately supported by the record.”
China’s National Medical Products Administration cleared Ascentage Pharma Group Corp. Ltd. to begin a registrational phase III trial of its BCL-2 selective inhibitor lisaftoclax (APG-2575) in combination with azacitidine for first-line treatment of newly diagnosed patients with higher-risk myelodysplastic syndrome.
Aiming to offer an advantage over Dupixent (dupilumab, Regeneron Pharmaceuticals Inc.), dermatology-focused Galderma Holding SA won clearance from the U.S. FDA for Nemluvio (nemolizumab) as a prefilled pen providing a subcutaneous injection to treat adults with prurigo nodularis (PN).
With inter partes reviews (IPR) once feared as patent killers, the mere fact that an IPR petition challenging a drug or device patent had been filed with the U.S. Patent and Trademark Office was enough to send a company’s stock tumbling. That initial fear has “kind of ebbed and flowed” over the past 12 years as the patent reviews established by the America Invents Act have come of age, Aziz Burgy, a partner and patent litigator at Axinn, Veltrop & Harkrider LLP, told BioWorld.
In turning the U.S. Department of Health and Human Services’ (HHS) one initial defeat into a victory, a federal district court handed HHS a 7-0 record in getting constitutional challenges to Medicare price negotiations dismissed.
Executives of ARS Pharmaceuticals Inc. are anticipating a quick switch for severe allergy patients following the U.S. FDA approval of Neffy (epinephrine nasal spray 2 mg), marking the first needle-free treatment option.
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