NATIONAL INSTITUTES OF HEALTH

NIH establishes pandemic preparedness research network, ReVAMPP, to develop vaccines and monoclonal antibodies for high-priority pathogens, focusing on virus families known to infect humans. NIAID commits $100 million annually to fund the program, aiming to fill knowledge gaps and enhance pandemic response capabilities.

The National Heart, Lung, and Blood Institute awarded $355,935 to Blacksburg’s Biotherapeutics, Inc. for asthma research. Biotherapeutics, formed in 2008, integrates nutraceuticals, pharmaceuticals, and informatics for precision medicine. This follows a $288,986 grant in August.

Nirrin Technologies received a $2 million SBIR Direct Phase II Grant from NIH for developing NIR spectroscopy for biomanufacturing. The HPTLS platform, used in the Atlas product, provides rapid chemical analysis, addressing data-collection challenges in the pharmaceutical industry. The grant will fund upstream bioprocessing applications and expand HPTLS-based product lines.

Ozempic and Wegovy (semaglutide) outperformed Saxenda (liraglutide) in weight loss, with 61% of obese and 23% of diabetic patients losing 10%+ body weight after a year. Saxenda achieved similar results in only 29% of obese and 12% of diabetic patients. Semaglutide users were more likely to lose 10%+ weight if treated for obesity, adhered to the drug schedule, had a higher BMI, and were female. Higher doses produced more weight loss.

Join the 1st Annual Clinical Trials and Translational Science Meeting on September 24-27, 2024, organized by NCTTC and NCGM, supported by AMED, and in collaboration with HERC, Oxford Population Health. The event aims to strengthen clinical trial capacities and establish partnerships, with registration available at bit.ly/nihncttcreg.

Eric J. Huang, MD, PhD, a neurodevelopmental and neurodegenerative diseases expert, will head the Department of Pathology & Immunology at Washington University School of Medicine in St. Louis starting Jan. 1.

Lipophilic statins reduce HCC risk; hydrophilic statins, aspirin, and metformin do not. A clinical trial (NCT05028829) is ongoing to confirm benefits of atorvastatin.

Aristotle's early animal dissections evolved into standard drug development practices by the late 1930s, leading to the 1938 Federal Food, Drug, and Cosmetic Act. Despite animal testing's contributions to medicine, 95% of drugs fail post-testing. Thomas Hartung's research at Johns Hopkins Center for Alternatives to Animal Testing advocates for AI and organoid cultures to replace animal tests, with some success. The FDA Modernization Act of 2023 no longer requires animal testing before clinical trials, and collaborations like CAAT's with the FDA aim to advance nonanimal testing methods. However, challenges remain in replacing animal models entirely due to technological limitations and systemic resistance.

Spark Biomedical partners with Battelle and Hazelden Betty Ford to develop an AI algorithm for detecting opioid withdrawal symptoms and cravings, funded by a $318,875 SBIR grant from NIDA. Phase I focuses on data collection and AI algorithm development, while Phase II aims to integrate the algorithm with Spark's FDA-cleared tAN® device, Sparrow® Ascent, for closed-loop neurostimulation treatment.

The FDA approved Johnson & Johnson’s Tremfya for treating adults with moderately to severely active ulcerative colitis, marking the first fully-human, dual-acting monoclonal antibody targeting IL-23 and CD64. Tremfya showed significant clinical and endoscopic improvements, with 50% and 45% of patients achieving clinical remission at 200 mg and 100 mg doses, respectively, compared to 19% in the placebo group. Common adverse events included respiratory tract infections, injection site reactions, and arthralgia.