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OTAT Town Hall on Cell Therapy CMC – The Recording is Available but Here’s an Appetizer

FDA Law

Brevig, Senior Regulatory Device and Biologics Expert — On December 7, 2022, FDA’s Center for Biologics Evaluation and Research (CBER) and the Office of Tissues and Advanced Therapies (OTAT) held a town hall to answer questions related to cell therapy and tissue-engineered products chemistry, manufacturing, and contr­­ols (CMC).

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New insights on genetic damage of some chemotherapies could guide future treatments with less harmful side effects

Medical Xpress

Im hopeful that the genomic information from this and future studies will guide choices of chemotherapies, and their adoption in clinical practice." We are constantly on the lookout for better ways of giving therapy and minimizing the side effects of toxic, systemic treatments. "Im

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Texas invests $50M in psychedelic drug research to treat addiction

Medical Xpress

The goal is to support clinical trials and bring in another $50 million in private investment to help ibogaine win approval from the U.S. Other states like Oregon and Colorado have already launched legal clinics using psilocybin, the compound found in mushrooms, The Times reported. Food and Drug Administration (FDA).

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Rewiring the body clock: Deep brain imaging reveals unexpected complexity in jet lag adjustment

Medical Xpress

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Preemies receive sucrose for pain relief—new research shows it doesn't stop long-term impacts on development

Medical Xpress

Long-term effects of pain in early life We collected data on the number of procedures, clinical exposures and sucrose doses from three NICUs across Canada. But as the findings from our Canadian study show, we urgently need research to improve long-term health outcomes for children born prematurely.

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Long-lasting HIV prevention shot headed toward approval

Medical Xpress

In clinical trials, no participants who received the injection acquired HIV. The long-acting shot may increase PrEP uptake, especially among those preferring injections over daily pills, but challenges remain in reaching underserved populations and ensuring equitable access. Consider supporting Science Xs mission by getting a premium account.