NATIONAL INSTITUTES OF HEALTH

FDA accepted Merck’s BLA for clesrovimab, an RSV antibody for infants, with a PDUFA date of June 10, 2025. Clesrovimab, a single-dose monoclonal antibody, offers immediate but short-term protection. It reduced RSV-associated hospitalizations by 84.2% in the CLEVER trial. RSV causes seasonal infections, hospitalizing 58,000-80,000 U.S. children under five annually. Abrysvo, an RSV vaccine, was approved in 2024 for adults and can protect infants from birth to six months.

Cedars-Sinai researchers identified brain cells for social situations, created AI models to predict postpartum depression risk, improved diversity in clinical trials, and developed a brain 'traffic map' for communication pathways.

Fostamatinib did not significantly decrease oxygen-free days or improve outcomes for hospitalized COVID-19 patients in a Vanderbilt-led international trial. Results suggest fostamatinib does not improve recovery from COVID-19 infection, possibly due to differences in patient characteristics between trials.

Prostate cancer reprograms androgen receptors to accelerate cell growth, releasing normal growth brakes. Researchers identified genes that suppress cancer cell growth, suggesting potential for new diagnostic tests and therapies to reactivate normal regulatory programs.

An Alabama woman, Towana Looney, received a gene-edited pig kidney transplant at NYU Langone Health, marking a significant breakthrough in xenotransplantation. Looney, who had been on dialysis for years due to kidney failure, is now the healthiest she's been in eight years. The procedure involved 10 gene edits to the pig kidney, aiming to reduce rejection and improve compatibility. This is the third time a gene-edited pig kidney has been transplanted into a living human, and Looney is the first to receive a kidney with 10 gene edits.

NeuroFieldz Inc. developed NeuroVEP, a portable wireless sensor system using visual evoked potentials (VEP) and Electric Field Encephalography (EFEG) with a virtual reality headset for vision and brain health diagnostics. NeuroVEP aims to address limitations of current cart-based systems, offering portability, reduced setup time, and AI-powered data analysis, with a potential market of $2.4 billion. The system also targets field-based concussion tests, attention disorder diagnosis, military visual testing, and neuromarketing. NeuroFieldz has received NSF and NIH SBIR grants totaling $2.75 million and seeks $8 million for FDA approval and product launch.

UC San Diego researchers found that Staphylococcus aureus induces overabundance of interleukin-10 (IL-10) in B cells, inactivating antibodies, and in helper T cells, shutting down their ability to fight the pathogen. Blocking IL-10 or boosting IL-17A during vaccination could make failed S. aureus vaccines effective.

Adjusting for principal components in genome-wide association studies can induce collider bias, especially in admixed populations where PCs may capture local genomic features instead of global ancestry. LD pruning is more effective than excluding high LD regions, but optimal parameters vary. Model-based ancestry inference may offer a better alternative in some cases. Careful pre-processing and checking of PCs are crucial to avoid spurious associations.

NIH study finds tecovirimat safe but ineffective in improving mpox resolution or pain among adults with mild to moderate clade II mpox. Study halted enrollment due to lack of efficacy.