In what is claimed as the first co-authored research between regulatory scientists at the U.S. FDA and a commercial manufacturer of organ-on-a-chip devices, CN Bio's Physiomimix system is shown to perform better than the current standard in vitro liver toxicity tests. In addition to maintaining its function for longer than 2D hepatocyte cultures or 3D spheroids, Physiomimix was found to reproducibly assess toxicity, metabolism and intracellular accumulation of drugs.
The U.S. Department of Health and Human Services (HHS) has awarded a contract for validation of lab-developed tests (LDTs) for the pandemic to a private company, a move that was apparently an effort to address the resource crunch at the U.S.
The U.S. FDA notice regarding device risk classification proposes to eliminate premarket notification requirements for several device types, a welcome development for industry. However, Amanda Johnston, senior attorney at Gardner Law PLLC, of Stillwater, Minn., told BioWorld that there is a question regarding the provenance of the document, as it fails to identify any FDA staff member. In addition, the notice omits several device types that are solid candidates for down-classification.
Alzheimer’s disease can be divided into multiple subtypes based on gene expression patterns, investigators at the Mount Sinai School of Medicine reported in the Jan. 6, 2021, issue of Science Advances. The work, corresponding author Bin Zhang told BioWorld, is “the first major finding of subtypes in Alzheimer’s disease.”
The Medicare Coverage of Innovative Technology (MCIT) program drew rave reviews when it was unveiled, but the associated proposal to redefine the term “reasonable and necessary” met with skepticism. The final rule includes some discussion of how private payer coverage might be leveraged to broaden the definition, but the Centers for Medicare & Medicaid Services (CMS) nonetheless punted on the question for now, promising to tackle it within a year.
COVID-19 undoubtedly will be the top U.S. health care priority for the 117th Congress and the incoming Biden administration, but that doesn’t mean prescription drug prices are no longer an issue. A raft of new-year price increases, many for already costly drugs, is ensuring drug pricing remains high on the congressional agenda.
As expected, pharmacy benefit managers are challenging a final rule that would end Medicare’s antitrust safe harbor for the rebates drug companies pay to the PBMs for formulary placement.
Steris plc has agreed to buy Cantel Medical Corp. for approximately $3.6 billion, in a cash and stock transaction that unites two key players in the infection prevention space. The combined company offers a number of synergies. Cantel’s medical portfolio is expected to bolster and expand Steris’ endoscopy offerings, with a full-suite of high-level disinfection consumables, capital equipment and services plus single-use accessories.
The U.S. FDA has issued an action plan for regulation of artificial intelligence and machine learning (AI, ML), which includes issuance of a draft guidance for change control for adaptive algorithms. There is no guarantee a final guidance will emerge before 2022, however, leaving developers with another year – perhaps longer – of uncertainty as to how to handle change control for their algorithms.
With so much ire in Congress directed toward U.S. prescription drug prices in 2019, it’s not surprising that prices remained relatively stable that year. That’s not to say there weren’t price hikes. In its second report on unsupported price increases, the Institute for Clinical and Economic Review (ICER) identified nine of the 100 top-selling drugs that had list price increases more than double the rate of medical inflation in 2019 and that accounted for the largest increases in U.S. spending on drugs.
RSS
