The U.S. National Institutes of Health reported the launch of a network for clinical trials that will examine the utility of cancer screening tools, which will start with a pilot study of multi-cancer detection (MCD) tests.
In recent years, the U.S. Congress has come to rely unduly on continuing budget resolutions to fund government operations, and fiscal year 2024 is no exception. The current continuing resolution (CR) for the FDA budget is set to expire March 1, but there is concern that Congress will resort yet again to a CR to cover the balance of fiscal 2024, a predicament which suggests that the FDA’s appropriations may be flat relative to fiscal year 2023.
Since its founding by the National Institutes of Health (NIH), the scientists of the All of Us Research Program have set the goal to analyze the largest diversity of the genomic population in the country and end the under-representation of its different groups. The project has expanded the vision of several pathologies, discovered thousands of new genetic variants, redefined the risk genes for common diseases, and stratified them, uncovering eight different forms in the case of type 2 diabetes (T2D). Their results create a pathway for a new age of precision medicine.
Investigators at the National Institute of Diabetes and Digestive and Kidney Disorders (NIDDK) have used a gene-constrained analysis to identify nine new Alzheimer’s disease (AD) risk genes that are possibly linked to the higher prevalence of AD in people with African ancestry. One of those genes, GNB5, regulates the stability of certain G protein-signaling proteins, which are activated by G protein-coupled receptors (GPCRs). The authors showed that mice with only one copy of Gnb5 developed more amyloid plaques and tau tangles than those with two copies.
The U.S. FDA may be the most prominent agency in the federal government when it comes to the use of real-world data (RWD), but the National Institutes of Health is keen to immerse itself in this trove of information. The agency has made a request for public comment on how NIH centers can best leverage RWD for biomedical and behavioral research, although some ethical and practical considerations may have to be overcome.
In a potential breakthrough for diagnosis and treatment development of liver disease, the Biomarkers Consortium’s Noninvasive Biomarkers of Metabolic Liver Disease (NIMBLE) project demonstrated that a blood test could diagnose nonalcoholic steatohepatitis (NASH), an increasingly common liver disease in the U.S. The study, published in Nature Medicine, identified four biomarkers that outperform current liquid biopsies for NASH.
The Hubmap consortium has released the atlas of three human organs, a cell-by-cell map based on overlaid images from microscopy and molecular data. Maps of the intestine, the kidney and the placenta, published in three simultaneous articles, have revealed the cellular morphology and architecture of these organs in healthy and diseased conditions.
The annual U.S. budget scrum is well underway in Washington, with drug pricing a persistent theme on Capitol Hill. Lawrence Tabak, acting director of the National Institutes of Health (NIH), said NIH’s view is that federal government exercise of march-in rights “is not the instrument to regulate drug pricing” as it would alienate drug makers and their investors, but Tabak vowed that the appropriate use of march-in rights is the subject of intense focus at the Department of Health and Human Services.
The Biden administration released a blueprint for the U.S. federal government’s fiscal 2024 budget year on March 9, which includes additional funding for pandemic preparedness. However, the White House has signaled its intent to drill down on drug prices with an increase in the scope of the number of drugs subject to Medicare price negotiations along with a 67% increase in the Advanced Research Projects Agency–Health (ARPA-H) to $2.5 billion, a boost that is sure to draw cheers from companies in the life sciences.
Engineers from Washington University in Saint Louis are developing a novel imaging technique for evaluating the use of alpha-particle emitting radiopharmaceutical therapy in tumors and other radiation-sensitive organs of the body. They have tested a low-count quantitative single-photon emission computed tomography (LC-QSPECT) method to provide reliable measurements of the radionuclide uptake in lesions and at-risk organs after its administration.