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Ensuring Data Integrity and 21 CFR Part 11 Compliance in NGS Workflows
Avance delivers end-to-end NGS workflow compliance with a robust framework for data integrity, pipeline validation, and audit readiness—tailored for regulated environments...
Groundbreaking Personalized Gene Therapy Saves Infant with Rare, Incurable Disease
An NIH-supported team has delivered the first personalized CRISPR-based gene therapy to an infant with CPS1 deficiency, offering new hope for rare disease treatment. The customized approach shows early success and may pave the way for future individualized therapies...
FDA Accelerates AI Integration to Transform Drug Review Processes
The FDA is embracing AI to streamline drug reviews, aiming for full implementation by June 2025. Following a successful pilot, this move could fast-track therapy approvals and reduce administrative tasks for scientists...
Verve Therapeutics Reports Promising Results for PCSK9 Gene Editing in HeFH
Verve Therapeutics’ VERVE-102 shows early success in lowering LDL cholesterol by 55% with a single dose, offering a potential one-time gene editing treatment for familial hypercholesterolemia...
MIT Engineers Develop Gene Circuit for Precise Control of Gene Therapy
MIT engineers have developed a gene circuit that precisely controls gene expression, offering potential breakthroughs in gene therapy for disorders like fragile X syndrome. This advancement helps ensure therapeutic genes are expressed at optimal levels, minimizing risks and paving the way for more effective treatments...
Imiquimod Shows Promise as Immune Enhancer in DNA-Based HIV Vaccine Study
A new preclinical study shows that Imiquimod enhances immune responses to an HIV DNA vaccine, offering promising implications for nucleic acid vaccine design and innate immune modulation strategies...