Evaluating Immunosuppressive Effects of In Utero Exposure to Drug and Biologic Products JULY 11 - 12, 2024

https://www.fda.gov/drugs/news-events-human-drugs/evaluating-immunosuppressive-effects-utero-exposure-drug-and-biologic-products-07112024?utm_medium=email&utm_source=govdelivery On July 11 and 12, 2024, the U.S. Food and Drug Administration’s (FDA’s) Center for Drug Evaluation and Research (CDER) Office of New Drugs (OND) Division of Pediatrics and Maternal Health (DPMH) and the University of Maryland’s Center of Excellence and Regulatory Science (M-CERSI) will hold a co-sponsored workshop entitled Evaluating Immunosuppressive Effects of In Utero Exposure to Drug and Biologic Products. The purpose of the workshop is to discuss transplacental transfer of drug and biological products with immunosuppressive properties and the potential clinical impact on the developing fetus and newborn infant, understand the gaps in knowledge, and consider innovative approaches to improve collection of relevant data. Workshop Objectives: Discuss the available data on the placental transfer of drug and biological products with immunosuppressive effects Discuss the potential clinical impact on infants exposed in utero Identify gaps in knowledge Explore innovative and practical approaches for collection of relevant data Allow an open dialogue amongst regulators, academia, industry, and patient organizations regarding the potential safety concerns and approaches to data collection Dates/Times of the Workshop: Day 1: Thursday, July 11 9:00 AM - 5:00 PM ET Day 2: Friday, July 12 9:00 AM - 1:00 PM ET Meeting Information: This workshop will be held both on-site at FDA’s White Oak Campus (Silver Spring, MD) and virtually. Registration is required for both online and on-site attendance. https://lu.ma/5vdmbibm?utm_medium=email&utm_source=govdelivery For additional details, contact the FDA Office of New Drugs public meeting support team at ONDPublicMTGSupport@fda.hhs.gov.

Improving the lives of all people through cancer research

https://www.cancer.gov/

Leading Change in Cancer Clinical Research, Because Our Patients Can’t Wait

https://www.cancer.gov/news-events/cancer-currents-blog/2024/clinical-trials-cancer-inviting-innovation?cid=eb_govdel Reshaping the cancer clinical trials infrastructure to overcome key bottlenecks will involve embracing technology and collaboration, and inviting innovation, explain NCI Director Dr. W. Kimryn Rathmell and NCI Special Advisor Dr. Shaalan Beg.v

Winners from the NIH Teen Mental Health Essay Contest Announced

https://nimhd.nih.gov/programs/edu-training/mental-health-essay-contest/?utm_medium=email&utm_source=govdelivery Read the 24 winning essays from the Speaking Up About Mental Health contest, sponsored by the National Institutes of Health. More than 370 essays were submitted by youth (16 to 18 years old) across 33 states. 18 Finalists shared $15,000 in prizes for gold, silver, and bronze awards. There were 6 honorable mention awards. The National Institute on Minority Health and Health Disparities (NIMHD), the National Institute of Mental Health (NIMH), and the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) co-funded the contest to start conversations about mental health to reduce stigma and foster resiliency among youth. The winning essays addressed topics like stigma, trauma, resilience, equity, and authenticity, and some included specific ideas on how to improve well-being among adolescents.

Does sleep really clean the brain? Maybe not, new paper argues A mouse study challenges popular “glymphatic” theory, but its methodology is drawing criticism 24 MAY 20244:40 PM ETBYSARA REARDON

https://www.science.org/content/article/does-sleep-really-clean-brain-maybe-not-new-paper-argues?utm_source=Live+Audience&utm_campaign=29096efd03-nature-briefing-daily-20240529&utm_medium=email&utm_term=0_b27a691814-29096efd03-50432164 Does sleep cleanse the brain? A study seems to cast doubt on the theory that we need sleep to clean waste products from the brain. In mice, sleep apparently slows down, rather than speeds up, their brain’s ability to remove a dye. Some researchers see this as a blow to the sleep clearance theory. Critics say that the study’s method for measuring dye removal could have damaged the brain’s waste-clearance system, and is too different from previous studies to credibly challenge them. The brain could even have different ways to clear small compounds such as a dye and large ones such as the beta-amyloid protein linked to Alzheimer’s disease, says brain circulation specialist Erik Bakker.

NEWS 28 May 2024 Autistic people three times more likely to develop Parkinson’s-like symptoms Largest study of its kind also finds increased risk in older adults with a range of intellectual disabilities. By Miryam Naddaf

https://www.nature.com/articles/d41586-024-01572-w?utm_source=Live+Audience&utm_campaign=29096efd03-nature-briefing-daily-20240529&utm_medium=email&utm_term=0_b27a691814-29096efd03-50432164 People with autism, intellectual disabilities or both are three times more likely than the general population to develop Parkinson's-like symptoms as they age — such as tremors and sudden freezing while walking. The study, the largest of its kind, followed almost a quarter of a million people in the United States aged 45 and older. It’s not clear whether this parkinsonism is linked to autism by an as-yet unidentified facet of brain health or development, or whether it could be affected by antipsychotic drugs given to some children with autism.

NEWS 28 May 2024 Correction 30 May 2024 The immune system can sabotage gene therapies — can scientists rein it in? People treated with gene therapy cannot receive a second dose for fear of a dangerous immune response. Researchers hope to find a way around this. By Heidi LedfordNEWS 28 May 2024 Correction 30 May 2024 The immune system can sabotage gene therapies — can scientists rein it in? People treated with gene therapy cannot receive a second dose for fear of a dangerous immune response. Researchers hope to find a way around this. By Heidi Ledford

https://www.nature.com/articles/d41586-024-01483-w?utm_source=Live+Audience&utm_campaign=29096efd03-nature-briefing-daily-20240529&utm_medium=email&utm_term=0_b27a691814-29096efd03-50432164 How to stop immune system sabotage Researchers are trying to prevent the immune system from attacking the relatively harmless viruses that are used in gene therapy to shuttle restorative genes into cells. Gene therapy can treat conditions including blood disorders, and degenerative eye and muscle diseases. But many people can’t receive more than one dose because they have antibodies against the gene-therapy viruses. Animal studies suggest that it’s possible to dampen the body’s ability to disable the viruses. There are also attempts to use other viruses that can better evade the immune system, or deliver genes inside protective fatty particles.