Continuing the spate of regulatory approvals for pulsed field ablation (PFA) devices around the world, Johnson & Johnson’s Biosense Webster Inc. unit secured CE mark for the Varipulse platform for treatment of symptomatic, drug-refractory recurrent paroxysmal atrial fibrillation.
The COVID-19 pandemic is well known for increasing telehealth utilization, including remote patient monitoring, but there are still issues with payer coverage policies even a year after the formal end of the public health emergency for COVID.
China’s National Medical Products Administration (NMPA) cleared 40 novel innovative drugs in 2023, of which nearly half were cancer therapies, marking a significant increase from the 21 new class 1 drugs approved in 2022.
Ariceum Therapeutics GmbH has received approval from the U.K.'s Medicines and Healthcare products Regulatory Agency (MHRA) to conduct a phase I trial (CITADEL-123) of 123I-ATT-001, its iodine-123 labeled PARP inhibitor, in patients with recurrent glioblastoma. The study is expected to begin in the U.K. in June of 2024.
“The market stinks,” Brian Johnson, a partner and vice chair of Wilmerhale’s corporate practice group, told a U.S. SEC advisory committee Feb. 27, as he painted a gloomy picture of last year’s IPO landscape in the U.S. While the scene was a little brighter than in 2022, a few key indicators could be worrisome, especially the median offering size, which is predictive of the strength of the IPO market, Johnson said
The U.S. National Institutes of Health reported the launch of a network for clinical trials that will examine the utility of cancer screening tools, which will start with a pilot study of multi-cancer detection (MCD) tests.
Arthex Biotech SL has received FDA clearance to initiate the phase I/IIa Arthemir study of ATX-01 for the treatment of myotonic dystrophy type 1 (DM1).
More than a year and a half after the U.S. FTC launched its investigation into how pharmacy benefit manager (PBM) practices and consolidation impact patients’ ability to access and afford their prescription drugs, the six biggest PBMs in the country have yet to fully comply with the agency’s June 2022 order to provide data and documents pertaining to certain business practices.
Drug pricing is playing an outsized role in the dynamics of the November U.S. election, creating turbulence for drug companies and for patients that will extend years after the votes are counted. During a Feb. 27 morning session on drug pricing trends during an election year at the BIO CEO & Investor Conference in New York, key opinion leaders spoke about their concerns, including the need to explain drug-pricing rationale to voters and patients in plain terms.
Allecra Therapeutics GmbH secured U.S. FDA approval for its beta-lactam/beta-lactamase inhibitor combination, Exblifep (cefepime/enmetazobactam), in complicated urinary tract infections, including pyelonephritis, in patients 18 years and older.
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