Bioatla Inc. has received FDA clearance of its IND application for BA-3361, a conditionally active biologic (CAB)-Nectin-4 antibody-drug conjugate (ADC) for the treatment of multiple tumor types.
Eisbach Bio GmbH has announced FDA clearance of its IND application for EIS-12656, a first-in-class orally bioavailable and blood-brain barrier-penetrant allosteric inhibitor of ALC1 (CHD1L), a key molecular machine in DNA repair. Enrollment will open in the second quarter in a phase I/II trial in patients with genetically defined advanced solid tumors, including patients progressing under PARP inhibitor treatment.
Vyne Therapeutics Inc. has received IND clearance from the FDA allowing it to initiate a first-in-human phase Ia study of VYN-202, an oral small-molecule BD2-selective BET inhibitor for autoimmune diseases.
With round 1 not yet completed, the U.S. Centers for Medicare & Medicaid Services (CMS) already is prepping for round 2 of the Medicare negotiations mandated by the 2022 Inflation Reduction Act. While the negotiation process will expand to Part B drugs in the future, round 2, like the first cycle, will be limited to single-source Part D drugs that account for some of the highest Medicare expenditures. However, the number of drugs selected for the next cycle could grow from the current 10 to up to 15
Checking off another item on its PDUFA VII to-do list, the U.S. FDA is releasing a draft guidance on using a logic model framework for risk evaluation and mitigation strategies (REMS).
The Australian government is investing AU$1.89 billion (US$1.25 billion) in what it is calling a “once-in-a generation transformation” of health and medical research in Australia with $1.4 billion tagged for new research for the Medical Research Future Fund.
Recent advances in artificial intelligence (AI) have generated a tsunami of popular dystopian musings, but the U.S. Patent and Trademark Office (PTO) has its own concerns about AI’s impact on intellectual property.
Masimo Corp.’s pride and joy, the Stork baby monitor, achieved a new developmental milestone with U.S. FDA clearance for over-the-counter marketing. The agency cleared Stork, which monitors key vital signs including oxygen saturation level, pulse rate and skin temperature, for use on a prescription basis in December. It has been available in the U.S. as a health and wellness device since August 2023.
The U.K. Medicines and Health Care Products Regulatory Agency (MHRA) is among the regulators across the globe that are scrambling to keep pace with artificial intelligence (AI) in medical devices, releasing an April 30, 2024, paper on its own approach. One of the key considerations in this paper is that MHRA expects to up-classify some AI-enabled device software functions in its ongoing regulatory revamp, a prediction that suggests a more stringent premarket path for these products in the years ahead.
The U.K. National Institute for Health and Care Excellence has posted an early value assessment review of digital technologies for the management of chronic obstructive pulmonary disease, giving the conditional nod to only one technology — the Mycopd app by London-based My Mhealth Ltd.