New England Biolabs Inc. (NEB) has launched its research use only product that can be utilized for the detection of the novel coronavirus, SARS-CoV-2 RNA. It is intended to serve as an alternative to RT-qPCR, enabling visual detection of amplification of SARS-CoV-2 nucleic acid in half an hour.

The U.S. Preventive Services Task Force (USPSTF) may recommend a fairly dramatic expansion of the populations that would be eligible for coverage for lung cancer screening, a bit of news that might be expected to cheer makers of CT imaging systems. However, compliance with the existing recommendations is already quite low, suggesting that an expansion of eligibility is likely to exert a negligible effect at best on utilization.

The checkpoint molecule CD47 has high hopes riding on it in oncology as being the innate immune equivalent of PD-1. Multiple companies are developing blockers against CD47 and/or its ligand, SIRPa, for the treatment of various tumors.

A first-of-its-kind clinical trial conducted by digital health startup AppliedVR suggests the computer-based technology is both feasible and effective for treating chronic pain in a patient’s own home.

Two subcommittees of the U.S. House Appropriations Committee have moved their respective appropriations proposals for the FDA and the NIH, restarting a process that has worked smoothly over the past couple of years. Still, Republicans in both committees objected to the use of emergency funding mechanisms in lieu of more routine appropriations.

On Tuesday, July 7, Judge Stacey Jernigan of the U.S. Bankruptcy Court in Dallas ruled that Endologix Inc. could take an initial draw of $10 million from a Chapter 11 loan from its largest lender, Deerfield Partners. A day earlier, Endologix filed a voluntary Chapter 11 case and a consensual plan of reorganization supported by Deerfield.

The question of prices for a COVID-19 vaccine have raged in recent days. Gary Disbrow, acting director of the Biomedical Advanced Research and Development Authority (BARDA), told members of a Senate committee that vaccines developed with the help of taxpayer funding will come with an appropriate reduction in price. However, CDC Director Robert Redfield emphasized that the cold-chain distribution system for those products requires the same kind of at-risk investment that is used for vaccine development.

The U.S. Centers for Medicare and Medicaid Services (CMS) posted the much-anticipated draft do-over of the mitral valve repair device coverage memo, and in the process renamed the policy the mitral valve transcatheter edge-to-edge repair (TEER) national coverage memo.

The push for a vaccine for the COVID-19 pandemic may have no parallel in pharmaceutical history, and FDA commissioner Stephen Hahn vowed in a Senate hearing that the agency will rely on the agency’s traditional standards for scientific evidence in premarket reviews of those vaccines.

Ethicon U.S. LLC has prevailed in a preliminary action seeking a temporary restraining order against Advanced Inventory Management (AIM) Inc., of Mokena, Ill., which is accused of having imported and sold surgical supplies falsely bearing the Ethicon trademark. Ethicon, a subsidiary of Johnson & Johnson of New Brunswick, N.J., further alleges the sutures were bacterially contaminated and defective.