The Biden administration has released an exceedingly brief budget framework for fiscal year 2022 that includes $6.5 billion for an advanced research program at the NIH, which mimics a similar program at the Department of Defense (DoD). Beyond that, there is a clear indication that the CDC would see an uptick in monies, but the proposal offers no numbers for the FDA budget, making this one of the skinnier budget proposals to come out of the White House in recent memory.
NASA is ready to begin testing the E-Nose COVID-19 screening device prototype developed by subcontractor Variable Inc., of Chattanooga, Tenn. NASA received $3.8 million from the Department of Health and Human Services to enhance E-Nose, which was originally developed to measure air quality inside spacecraft. The updated version is intended to facilitate screening for SARS-CoV-2 by "sniffing out" the signature volatile organic compounds (VOCs) in the breath of infected individuals.
The authors of a recent journal article see problems with the FDA’s approach to premarket review of artificial intelligence (AI) algorithms, including an undue reliance on single-site algorithm development. Regulatory attorney Brad Thompson told BioWorld, however, that hospital administrators want algorithms that maximize accuracy for their populations and are not averse to in-house development of just such an algorithm, thus creating a source of tension between what hospitals want and what the FDA expects.
The FDA has its hands full with the impact of the mutations to the SARS-CoV-2 virus, but test developers can count on an ever-increasing base of data for those viruses thanks to a new contract taken by the CDC. The CDC indicated recently that its sequencing efforts and that of other organizations churned out nearly 14,000 sequences for the week of April 3, but Aegis Sciences Corp., of Nashville, Tenn., announced April 7 that it had undertaken an agreement to perform next-generation sequencing of samples from all 50 states and Puerto Rico, ensuring plenty of access to up-to-date information on those mutations.
In the debate over the interpretation of the U.S. government’s patent march-in rights under the Bayh-Dole Act, those arguing for march-in as a price control cite the billions of tax dollars being invested in scientific research at universities that may lead to marketable inventions.
The shortage of hearts for transplant is a matter of record for both cardiologists and patients, a problem that Transmedics Inc. proposed to solve with its Organ Care System (OCS). Despite several significant issues associated with the pivotal clinical study for the OCS, Transmedics snared a 12-5 vote that the benefits of the system outweigh the risks, an outcome that may bring at least some relief for heart transplant patients by mid-year if analyst expectations are on target.
Device reprocessing has intermittently prompted FDA action in an effort to tamp down on infection-driven adverse events for various types of endoscopes, and the latest spate of events involves endoscopes used in urological applications. While the three associated fatalities all took place outside the U.S., the FDA nonetheless indicated that it is considering the possibility that a device redesign is in order, a move the agency endorsed in connection with infections blamed on duodenoscopes.
Nearly 16,500 groups and individuals put in their two cents on a proposed National Institute of Standards and Technology (NIST) rule clarifying that the U.S. government, under the Bayh-Dole Act, can’t march in on patents derived from federally funded research just because it doesn’t consider the price of the resulting product “reasonable.”
Nevro Corp.'s spinal cord stimulation system cut diabetic neuropathy pain in half or more in 85% of patients in a study published on April 5 in JAMA Neurology. Patients receiving the stimulation treatment delivered by the Senza system experienced an average reduction in pain of 76% at six months in the largest clinical largest trial to date to evaluate the use of spinal cord stimulation (SCS) in painful diabetic neuropathy (PDN).
The Federal Trade Commission (FTC) is seeking to block Illumina Inc.’s $7.1 billion purchase of Grail Inc., claiming the deal will “diminish innovation in the U.S. market” for multicancer early detection (MCED) tests, which could be used to flag dozens of tumor types when they are still treatable. Illumina has vowed to “pursue all legal options” to complete its acquisition of Grail, arguing that it does not compete with Grail and is committed to providing “unfettered access” to its NGS technology.
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