The U.S. FDA approved 17 drugs in July, down from 28 in June, which marked the third-highest month in BioWorld’s records. On average, the FDA approved approximately nearly 19 drugs per month so far in 2024, compared to 16 per month in 2023, 12.5 per month in 2022, and 17 per month in both 2021 and 2020.
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.
“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.
Stereotaxis Inc. Genesisx received the greenlight from the EU authorities for its next generation robotic system, which it says builds on the benefits and performance of the previous Genesis while greatly reducing its barriers to adoption.
Device makers and physicians alike were less than enthused about several features of the draft Medicare inpatient rule for fiscal year 2025, but thanks in part to support from the device industry, the final rule provides a new code that encompasses both left atrial appendage closure and ablation, a change that may reduce spending without dinging sales of these devices.
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.
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