Industry groups call for significant reforms to MDR, IVDR: Industry stakeholders say the European Union’s Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) have created significant hurdles for manufacturers and threaten patient access to treatments. They are calling on European legislators to make significant changes to the regulations, as well as the Clinical Trials Regulation (CTR) to rectify the problems.
H5N1 is firmly entrenched in the United States, experts say: Avian influenza is evolving unpredictably, adapting to mammals and raising concerns about its potential to cause a human pandemic, says computational biologist Martha Nelson, a Scientist at the NIH who has been monitoring H5N1 outbreaks. Confirmation of infections in rodents near farms is particularly concerning, says veterinarian and epidemiologist Meghan Davis. “There is absolutely no chance of containment, and we now have to think about mitigation and monitoring,” said epidemiologist Natasha Bagdasarian.
Universities brace for NIH grant cuts: Columbia University is facing a major funding crisis after the Trump administration canceled $250 million in NIH grants, citing alleged antisemitic harassment. The move, which affects one-third of Columbia’s NIH funding, has halted research projects and prompted the University to negotiate with officials while supporting staff and students. Other universities are on alert as the administration investigates 59 more schools for similar issues.
Antibody studies offer new hope for HIV prevention, cure: The Conference on Retroviruses and Opportunistic Infections highlighted promising advancements in HIV research amid funding cuts. Gilead Sciences presented data showing a single injection of lenacapavir could prevent HIV for a year, surpassing previous pre-exposure prophylaxis methods. Additionally, studies on broadly neutralizing antibodies demonstrated potential in controlling HIV without antiretroviral drugs, with some participants maintaining viral suppression for extended periods.
Stem cell therapy enables paralyzed man to stand again: In a small clinical trial involving people with paralysis, one (1) person was able to stand on his own after receiving injections of neural stem cells derived from induced pluripotent stem cells, demonstrating the potential of reprogrammed cells in facilitating nerve regeneration. Another participant regained some movement; however, two (2) others showed no significant improvement.
As the compliance date for FDA’s new phased-in regulatory approach to laboratory-developed testing oversight nears, advocacy groups are attempting to see hew governmental standards set.
Panel: New body needed to guide US biomedical research: A panel convened by the National Academy of Medicine (NAM) recommends creating a new advisory body to guide United States biomedical research policy, aiming to better coordinate public and private funding to address health challenges like obesity and health inequities. The report highlights the need for a national strategic vision and improved funding collaboration across sectors, without necessarily increasing the NIH budget. It also emphasizes the importance of convergence science and diversifying the research workforce.
Next-generation obesity drugs are on the horizon: The success of semaglutide and tirzepatide have fueled the development of over 100 anti-obesity drug candidates, with an anticipated market value exceeding $100 billion by 2030. These emerging drugs, including bimagrumab to prevent muscle loss and retatrutide targeting multiple hormone receptors for enhanced weight loss, aim to improve efficacy and tolerability and address current treatment limitations.
The US Food and Drug Administration (FDA) announced plans to implement AI tools throughout the Agency to assist in conducting scientific reviews following the successful completion of a pilot program that incorporated generative AI into reviews.
The United States Food and Drug Administration (FDA) announced it will expand its effort to conduct unannounced inspections of foreign manufacturing facilities that produce medical products and foods.