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.
With yet another deadline looming for passage of spending bills for the U.S. federal budget, Congress has drafted an omnibus spending bill that would extend coverage of Medicare telehealth services. The problem with the legislation in the eyes of many stakeholders is that the Verifying Accurate Leading-edge IVCT Development (VALID) Act is not part of the package that must be passed by Dec. 23, an omission that leaves lab-developed tests (LDTs) in a nether world of regulatory ambiguity.
Peking University researchers in collaboration with the NIH have discovered a new biochemical pathway related to a bacterium that eliminates nicotine in the intestine. The findings could lead to new ways to improve nonalcoholic fatty liver disease in smokers.
Peking University researchers in collaboration with the NIH have discovered a new biochemical pathway related to a bacterium that eliminates nicotine in the intestine. The findings could lead to new ways to improve nonalcoholic fatty liver disease in smokers.
Peking University researchers in collaboration with the NIH have discovered a new biochemical pathway related to a bacterium that eliminates nicotine in the intestine. The findings could lead to new ways to improve nonalcoholic fatty liver disease (NAFLD) in smokers. In addition to the lung and the brain, nicotine can accumulate in the intestine, where the bacteria Bacteroides xylanisolvens could reduce its concentration and the severity of NAFLD. In their study, published in Nature Oct. 19, 2022, the researchers described the enzymes involved in this process and a new undiscovered pathway.
