More telling than the U.S. FDA’s Oncologic Drugs Advisory Committee’s 4-5 vote May 21 on the overall benefit-risk of Urogen Pharma Inc.’s UGN-102 (mitomycin) is that the panel’s urology specialists and the patient representative all voted yes, saying the drug would be an important alternative to what is often a continuing cycle of surgery for patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer.
Innovative Health LLC, of Scottsdale, Ariz., obtained a jury verdict of $147 million against Johnson & Johnson’s Biosense Webster unit for practices that thwarted the use of less costly reprocessed medical devices.
The credibility gap in psychedelic drug development continues to narrow with positive top-line data from a Beckley Psytech Ltd. phase IIa study in depression. The results keep the treatment into a tight race with GH Research plc, which also has an inhalable drug in development.
With a PDUFA date less than four weeks away, Urogen Pharma Inc. has been having a rough ride on the Street since the U.S. FDA released a joint briefing document for the May 21 Oncologic Drugs Advisory Committee meeting on UGN-102 (mitomycin).
Senseonics Holdings Inc. and Sequel Med Tech LLC revealed plans to develop an automated insulin delivery system using the Eversense one-year, implantable continuous glucose monitoring system to increase flexibility for people with type 1 diabetes.
First quarter 2025 results presentations were the first chance analysts have had to quiz pharma companies in public about their exposure to the threat of U.S. import tariffs and what action they are taking to mitigate the risks.
With strong one-year results from the PULSAR trial, Kardium Inc. could soon be jockeying for third place in the race for pulsed field ablation market share. Boston Scientific Corp. clearly won the roses, with Medtronic plc solidly positioned to place, but the show spot – previously called as a battle between Johnson & Johnson and Abbott Laboratories – could go to this Canadian dark horse.
First quarter 2025 results presentations were the first chance analysts have had to quiz pharma companies in public about their exposure to the threat of U.S. import tariffs and what action they are taking to mitigate the risks. BioWorld reporters have listened in to the analyst meetings and filleted out responses to the tariff question by CEOs and senior executives, to get an overview of how the sector as a whole is responding. One thing is very clear: While pharmaceuticals are for now exempt from tariffs, the industry has been bracing for their imposition whilst at the same time lobbying strongly against them, on the grounds that drug shortages could result.
Clinical results offered at the recent meeting of the American Urological Association in Las Vegas signal that better treatments may lie ahead for non-muscle invasive bladder cancer.
The U.S. FDA approval of Johnson & Johnson’s Imaavy (nipocalimab-aahu) for myasthenia gravis brings the monoclonal antibody into a treatment space that teems with competition, both approved and in-development candidates. The human Fc receptor inhibitor was approved to treat generalized myasthenia gravis in patients who are 12 years and older. Patients must be anti-acetylcholine receptor [AChR] or anti-muscle-specific kinase [MuSK] antibody positive. Anti-AChR and anti-MuSK antibody-positive individuals make up more than 90% of all antibody-positive gMG patients.
