FDA Approves Three (3) Food Colors from Natural Sources

The U.S. Food and Drug Administration (FDA) announced it granted three (3) new color additive petitions that will expand the palette of available colors from natural sources for manufacturers to safely use in food.

Blood of a man who has had 200 snake bites helps make a potent antivenom:  Treatment combines existing drug with antibodies from hyper-immune reptile collector, raising both hopes and ethical concerns.

One man’s immunity paves the way for a universal snake antivenom: Scientists have used antibodies from the blood of Tim Friede, a man who deliberately exposed himself to venomous snakebites, to develop a potential universal antivenom effective against multiple deadly species, according to a study in Cell. Over nearly two (2) decades, Friede built immunity by injecting himself with 650 doses of venom and enduring roughly 200 bites from 16 deadly snake species, experiencing severe reactions like anaphylaxis, hives and blackouts along the way.

Experts caution to maintain inspection readiness despite recent upheaval at FDA

Pharmaceutical and medical device manufacturers should not assume that recent staff cuts at the US Food and Drug Administration (FDA) mean the Agency will inspect less often and take fewer enforcement actions, according to a panel of experts who spoke at a Food and Drug Law Institute (FDLI) webinar on 01 MAY 2025.

MedCon:  FDA officials review Quality Management System Regulation (QMSR) as deadline approaches

The upcoming change to Quality Management System Regulation (QMSR) is similar to requirements of the Quality System (QS) Regulation under 21 CFR 820; however, not so similar that companies should think they have no work to do during the transition, US Food and Drug Administration (FDA) officials said at the 2025 MedCon conference in April 2025, sponsored by the AFDO/RAPS Healthcare Products Collaborative.

How fast is your brain aging?  Proteins in blood offer clues:  Biomarkers could monitor ageing in the brain, revealing ways to treat dementia and other age-related brain disorders.

Blood proteins may predict speed of brain aging: Researchers have identified 13 blood proteins that predict brain aging speed, with eight (8) linked to faster aging and five to slower aging, according to a study in Nature Aging. The study used a machine-learning model to analyze brain scans and blood samples from more than 10,000 people, finding that the brain ages of participants differed from their chronological ages by about three years on average.

Regulatory T-cell therapy calms autoimmune response from gluten-sensitive T cells in mice (good news for those with Celiac Disease)

Study with mice shows potential of engineered T-cells to treat Celiac Disease: A cell therapy for Celiac Disease that involves engineering regulatory T-cells to activate in the presence of gluten reduced the immune response associated with the disorder, according to a study in Science Translational Medicine. The study demonstrated the potential of this therapy in human cell cultures and mouse models, and could lead to the first treatment for Celiac Disease beyond a gluten-free diet.

HIV  –  how close are we to a vaccine or a cure:  Stem-cell transplants have freed seven people of the virus, but researchers say most long-term interventions remain a distant prospect.

Challenges and advances in HIV treatments: It was recently announced that a seventh (7th) person had been “cured” of HIV using a stem-cell transplant, a method that is effective in patients with both HIV and cancer that require bone marrow transplants; however, unsuitable for widespread use due to potential complications. Current HIV research is concentrated on long-acting injectable treatments, vaccines and gene therapies aimed at controlling latent reservoirs of infected cells or targeting the CCR5 receptor that HIV uses to enter cells, with some approaches in early clinical trials.