HHS releases government-wide policy to prohibit gain-of-function research - The Cancer Letter

• A Cyclosporiasis outbreak has been reported across 17 states, with 145 confirmed cases of the gastrointestinal disease caused by the Cyclospora parasite. • The CDC has issued an alert to health care workers to ensure rapid diagnosis and proper response, as the infection spreads via contaminated food or water.

• An FDA advisory panel voted on Thursday to support trial results for Replimune's drug, RP1, which targets a specific type of skin cancer. • The FDA had previously declined to approve RP1 twice, most recently in April, due to a lack of a control group and insufficient evidence of effectiveness.

• The U.S. is seeing a surge in vaccine policy activity, with over 400 state vaccine bills introduced and nine new laws enacted. • New federal charters have been established through July 2028, focusing on healthy lifestyle initiatives, dietary supplements, and FDA-approved off-label drug use.

• An FDA advisory panel voted 10-3 on Thursday in favor of Replimune Group's experimental melanoma treatment, RP1. • The committee concluded that efficacy results from the company's IGNYTE clinical trial were both evaluable and clinically meaningful.

• A new AI tool called MEDWACS has been developed to identify undiagnosed individuals with type 2 diabetes using over 30 years of U.S. health data. • The findings, published in the Journal of Clinical Epidemiology, highlight the tool's ability to detect the disease before patients seek medical testing.

• The nominee for the director of the Centers for Disease Control and Prevention (CDC) has advanced to a full Senate vote. • The federal government indicated that Medicaid work requirements will not be delayed, maintaining current policy timelines.

• The FDA’s Pharmacy Compounding Advisory Committee has approved the peptides epitalon and semax for compounding. • Medical experts warn that this decision may mislead the public into believing the FDA has thoroughly evaluated the safety and efficacy of these compounds.

• The FTC and multiple states are suing telehealth company Hims & Hers for allegedly sharing sensitive patient health data with third-party advertisers. • Novo Nordisk is facing a shareholder lawsuit claiming the company misled investors regarding clinical trial results for its investigational weight-loss drug, CagriSema.

• An FDA advisory committee has voted in favor of RP1, an experimental melanoma drug developed by Replimune, despite the therapy being rejected in April. • The decision comes during a review meeting where experts evaluated the drug's efficacy and safety for treating melanoma patients.

• An infectious disease specialist is debunking common misconceptions about measles as U.S. cases reach a 35-year high. • The doctor draws on professional experience treating patients during the 2014-2015 Disneyland outbreak, which spread across six U.S. states and into Canada.

• The COVID-19 pandemic underscored an urgent requirement for rapid, accurate, and accessible diagnostic tools to improve clinical decision-making and public health surveillance. • Point-of-care testing (POCT) has become a vital component of decentralized healthcare, allowing for diagnostic procedures to be performed outside of traditional laboratory environments.