University of Pennsylvania

AI-driven medical devices, including brain-computer interfaces by Elon Musk's Neuralink, are transforming healthcare, prompting increased FDA scrutiny. Dr. Michelle Tarver takes over the FDA's device division amid concerns over industry influence and ethical conflicts, particularly with former director Dr. Jeffrey Shuren's ties to the device industry. The FDA's reliance on industry user fees raises questions about public health protection versus industry profit. AI in healthcare, though promising, faces challenges in oversight and potential biases, with the FDA acknowledging its limitations in regulating the rapidly evolving field.

Authors from various departments and institutions contributed equally to the research.

Candel Therapeutics' Q3 2024 report highlights financial performance, business operations, and strategic initiatives, including advancing clinical trials for CAN-2409 and CAN-3110, receiving FDA designations, and collaborations with the University of Pennsylvania. The company faces financial and operational risks, necessitating additional funding and strategic focus on key clinical programs.

Scaling gene therapy trials for rare diseases involves addressing patient heterogeneity, leveraging specialized surgeons and centers, selecting appropriate trial sites, managing logistical and manufacturing challenges, ensuring consistent patient care, and forming strategic partnerships. Success requires a blend of scientific insight, logistical strategy, and robust partnerships.

UNMC College of Medicine received over $7 million in new funding in September, with grants awarded to various faculty members for studies ranging from cardiovascular disease diagnosis to HIV/SIV reservoirs and COVID-19 eye studies, among others.

Trump's presidency may bring changes to federal health agencies, with potential influence from Robert F. Kennedy Jr. on FDA policies. The drug industry is concerned about Kennedy's role, while biotech leaders are optimistic about reduced scrutiny of mergers and acquisitions under the FTC. Trump's potential policies on drug pricing and U.S. firms' ties to China are also under scrutiny.

New guidelines for AI use in brain cancer diagnosis and treatment ensure reliable clinical trial results and patient protection, addressing variability in radiologist interpretations and promoting objective AI analysis of tumor images.

Gene therapy fidanacogene elaparvovec outperforms prophylaxis factor IX concentrate in reducing bleeding and stabilizing factor IX in hemophilia B patients, suggesting a more durable treatment. Published in the New England Journal of Medicine, the phase 3 study involved 45 patients, showing reduced annualized bleeding rates and mean factor IX activity at 15 months. Despite some resuming prophylaxis, the therapy demonstrated a favorable benefit-risk profile.

Dr. Alan Wein, a 60-year veteran in urology, reflects on his career, including coining the term 'overactive bladder' and creating a classification system for urinary disorders. He discusses the evolution of the field and his current role at the Desai Sethi Urology Institute, offering advice to aspiring urologists.