The Supreme Court heard the case of Minerva Surgical Inc. v. Hologic Inc., which takes up the question of assignor estoppel for patents, but the discussions that peppered the April 21 hearing lent little clarity as to how the nine justices will decide the case.

The CDC’s Advisory Committee on Immunization Practices again took up the matter of risk vs. benefit with the COVID-19 vaccine made by Johnson & Johnson, and proved significantly less skeptical at its second meeting. The FDA and CDC swiftly determined that the recommended pause should be lifted and use of the vaccine should resume.

As of 2020, the NIH had identified 507 grant recipients who potentially had undisclosed conflicts of interest, with many of those conflicts involving affiliations with foreign governments that may expect the scientists to share or steal NIH-funded research.

HONG KONG – Celltrion Inc. continues its quest to take its Diatrust COVID-19 Ag Rapid Test overseas, after receiving the FDA’s emergency use authorization (EUA). The Incheon, South Korea-based company also submitted results of clinical trials in which 450 people throughout the U.S. were tested between February and March 2021 to the regulator, with the trial results currently under review.

The FDA reported a new streamlined pathway for diagnostic testing as part of a serial testing program using pooled samples, a pathway that should enable the further reopening of the economy. However, the FDA’s Tim Stenzel said April 21 that this new pathway relied on accumulated data for molecular testing, and that the agency lacks sufficient data to provide a similar mechanism for this use of antigen tests.

A team led by researchers at the Institute of Bioelectronic Medicine at The Feinstein Institutes for Medical Research, the research division of New York’s Northwell Health, developed a long-term implant model for vagus nerve stimulation (VNS) in mice that enables study of bioelectronics in chronic disease. The research was published in Elife, with a full description of the surgical technique and methods for calibrating the stimulation dose to enable other labs to use the methods to advance bioelectronic medicine.

Safeguard Medical LLC further consolidated its position in the first responder market with the acquisition of H&H Medical Corp. Williamsburg, Va.-based H&H produces military-grade trauma response products for field medics and emergency responders. "Our mission at Safeguard Medical is to equip and enable responders at every skill level to preserve life in any environment. The acquisition of H&H adds another trusted brand to our market-leading portfolio and expands our ability to partner with life-saving responders around the world," said Adam Johnson, Safeguard Medical’s CEO.

The negotiations for the next medical device user fee agreement are well underway, but the FDA is pressing the case for a substantial increase in device user fees. While the controversy over the cost of each addition to the FDA staff has not gone away, the agency continues to compare device user fees to drug user fees even though the drug industry is populated by much larger companies, thus nullifying any such comparisons in the view of device makers.

The FDA lost another hearing in the lawsuit filed against the agency by Genus Medical Technologies LLC in a case that yet again resurrects the product classification question. Both courts that heard the lawsuit asserted that the FDA does not enjoy unfettered discretion to classify a device as a drug merely as part of its authority under the Administrative Procedures Act (APA).

Agnovos Healthcare LLC, a company using regenerative medicine to treat localized effects of bone disease, has received the FDA’s nod for an IDE clinical trial to assess its AGN1 local osteo-enhancement procedure (LOEP) small-volume (SV) kit in patients with vertebral compression fractures (VCFs). The investigational device is intended to treat stable but painful VCFs via a minimally invasive procedure. The kit, which comes in the form of two single-use trays, contains a calcium-based, resorbable, triphasic implant material that is designed to align the pace of resorption with bone formation, providing treated vertebrae with immediate and durable protection.