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.

The U.S. Centers for Medicare & Medicaid Services (CMS) issued a final version of a proposed rewrite of the national coverage determination (NCD) for mitral valve repair devices that includes a coverage with evidence development (CED) mandate. The final also retains the draft’s provisions for secondary mitral valve regurgitation, which analysts say will double or even triple the market for devices thus approved by the FDA.

When it comes to leveling the playing field for foreign-based biopharma and medical device companies, China has made a lot of promises, but delivering on those promises is what matters. Throughout its annual assessment for Congress of China’s commitment to World Trade Organization principles, the U.S. Trade Representative (USTR) noted the many promises China has made over the years that have yet to be kept.

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.