Heartflow Inc. reported exceptional results in a study published in the Journal of Vascular Surgery that revealed coronary computed tomography angiography with fractional flow reserve care reduced mortality by more than 60% at five years in patients with peripheral arterial disease undergoing major vascular surgery, far surpassing the current standard of care.
The U.S. FDA and industry have been in scramble mode for some time to address the Environmental Protection Agency’s actions on ethylene oxide, but some manufacturers must also deal with other regulators’ perceptions of what constitutes an acceptable method of sterilization.
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Checking off another item on its PDUFA VII to-do list, the U.S. FDA is releasing a draft guidance on using a logic model framework for risk evaluation and mitigation strategies (REMS).
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.
Philadelphia-based Latus Bio Inc., co-founded by serial biotech entrepreneurs P. Peter Ghoroghchian and Beverly Davidson, launched on May 2 with two lead adeno-associated virus (AAV)-based gene therapy candidates and $54 million in a series A financing.
In the wake of Novo Nordisk’s semaglutide nabbing the title of the U.S.’s biggest blockbuster drug, it’s little surprise that Amgen Inc.’s obesity candidate, Maritide (maridebart cafraglutide), hogged the stage during the firm’s first-quarter earnings call after market close May 2, with company executives touting promising phase II data and a differentiated profile, sending shares of Thousand Oaks, Calif.-based Amgen (NASDAQ:AMGN) up nearly 12% to close May 3 at $311.29.
Cytovale Inc. has posted a feverish run of wins lately. The company gained U.S. FDA clearance for its Intellisep rapid test for sepsis in January 2023, raised $84 million in a series C in November and just published results showing the test has negative predictive value of 97.5%.
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. PTO recently announced that it is looking for feedback on the use of AI to produce what litigants might spuriously claim is prior art, a concern that must be addressed if the patent system is to avoid crashing under the weight of an unmanageable volume of AI-generated clutter.
Apple Inc. said the U.S. FDA has approved the Apple Watch's atrial fibrillation (AF) history feature under its rigorous Medical Device Development Tools (MDDT) program that specifies what devices health professionals can rely on.
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