NATIONAL INSTITUTES OF HEALTH

A study found that measuring circulating tumor cells (CTCs) at the onset of metastatic prostate cancer can predict treatment response and survival, guiding treatment decisions and clinical trial eligibility.

Dr. Adrien Eshraghi and Dr. Ronna Hertzano highlight gene therapy, implantable hearing aids, stem cell therapies, and drug therapies as leading research areas in hearing loss at the AAO-HNSF meeting. Otoferlin gene therapy shows promise for congenital deafness, while cochlear implants remain crucial for early intervention. Pharmaceutical research is gaining traction due to a growing market for hearing loss treatments.

FDA clears Healgen Rapid Check COVID-19/Flu A&B Antigen Test for OTC use, the first non-EUA authorized flu detection test. It uses nasal swabs for individuals 14+ or children 2+ with adult assistance, providing results in 15 minutes. Test showed >90% sensitivity and >99% specificity.

Monica Bertagnolli, director of the National Institutes of Health, shared her journey and the importance of community-focused biomedical research at a virtual event. She highlighted the new initiative, CARE for Health, aiming to integrate research into primary care settings and address community-specific health needs. Bertagnolli emphasized the need to build trust within communities and earn participation in research, drawing from her personal experience with breast cancer. The event, co-founded by community leaders, aims to foster collaboration between faith communities and NIH for sustained health initiatives.

In a randomized clinical trial with 797 adults, no significant differences were found between once-daily vs more frequent screening and pressure-supported vs T-piece SBTs for time to successful extubation. However, a significant interaction was identified: more frequent screening with pressure-supported SBTs increased the time to successful extubation, while once-daily screening with pressure-supported SBTs did not reduce this time compared to T-piece SBTs.

Article details methods for nanoruler design, cell culture, brain slice preparation, participant diagnosis, CSF sample collection, immunostaining, protein purification, PAGE, dot blot, 1,6-Hexanediol treatments, X10 and ZOOM expansion procedures, mCLING structure simulation, microscope systems, image acquisition, image processing, image analysis and statistics, optimization, 3D model reconstruction, and reporting summary.

Matthew Birnbaum, with over a decade in life sciences, joins Kolon TissueGene as Product Launch Specialist to drive the launch of TG-C, a cell and gene therapy for osteoarthritis. TG-C aims to provide pain relief and improve function, potentially delaying the need for surgery.

The FDA has granted marketing authorization to the Healgen Rapid Check COVID-19/Flu A&B Antigen Test, the first OTC test using a traditional premarket review pathway. The test, authorized for individuals aged 14+ or 2+ with adult-collected samples, detects SARS-CoV-2 and influenza A and B within 5 days of symptom onset, delivering results in 15 minutes. It correctly identified 99% of negative and 92% of positive SARS-CoV-2 samples, and 99.9% of negative flu A and B samples, 92.5% of positive flu A samples, and 90.5% of positive flu B samples.

Bret Rutherford, a former psychiatry researcher at New York State Psychiatric Institute and Columbia University, committed research misconduct by falsely reporting that all subjects met inclusion/exclusion criteria for late-life depression studies, according to the U.S. Office of Research Integrity. Rutherford's false reporting affected the methods and results of five published papers, three of which were retracted and two corrected. He agreed to a three-year ban on U.S. government funding followed by supervised research.

FDA grants Fast Track designation to Wockhardt's once-a-day antibiotic WCK 6777 for cUTI and cIAI. WCK 6777, active against meropenem-resistant Gram negative pathogens, completed a Phase I study with a promising safety profile.