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.
A China-based manufacturer of active pharmaceutical ingredients (API) suspended producing API for the U.S. market following an FDA inspection that found “significant deviations” from good manufacturing practices at the facility.
SK Bioscience Co. Ltd. of Seongnam-si, South Korea, gained the World Health Organization’s (WHO) prequalification certification for typhoid conjugate vaccine, Skytyphoid (NBP-618), on Feb. 23. Skytyphoid conjugates a polysaccharide of typhoid bacteria, which serves as an antigen, to a diphtheria toxin protein called diphtheria toxoid that acts as a carrier.
Korean neurodegenerative disease-focused Aribio Co. Ltd. gained the U.K.’s regulatory clearance to start the phase III Polaris-AD trial on AR-1001 (mirodenafil), an investigative therapy for early Alzheimer’s disease (AD). The U.K.’s Medicines and Healthcare products Regulatory Agency gave notice of acceptance to Seoul, South Korea- and San Diego-based Aribio for the clinical study on Feb. 21 after “confirming a favorable ethical opinion,” Aribio said. AR-1001 is an oral phosphodiesterase-5 inhibitor under development to treat early AD.
In the end, Minerva Neurosciences Inc. NDA submission wasn’t able to overcome the U.S. FDA’s concerns regarding data for dual 5-HT2A/sigma 2 antagonist roluperidone. The agency issued a complete response letter (CRL) for the application, which had been seeking approval as the first treatment specifically targeting negative symptoms of schizophrenia.
The U.S. FDA’s approach to predetermined change control plans (PCCP) for medical devices has been widely viewed through the lens of artificial intelligence software, but the potential scope of PCCP is much broader than merely evolutionary software and iterative device designs.
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