FDA’s regulatory outlook - POLITICO

• Prediction markets such as Kalshi and Polymarket are now allowing users to wager money on the outcomes of drug approvals. • Kalshi is further expanding these offerings by planning to enable betting on the specific results of clinical trials.

• MedPage Today has compiled a series of health updates, including the release of Dr. Anthony Fauci's diaries and a recall of cold brew coffee. • Food safety experts are warning that federal budget cuts have hindered the ability to detect and stop the spread of potentially deadlier foodborne illness outbreaks.

• An FDA advisory committee is meeting this week to review applications for novel peptide therapies that were previously rejected by former agency officials. • Affiliates of the American Academy of Peptide Medicine allege the FDA ignored critical safety and efficacy data, while industry and consumer advocates warn that approval would bypass traditional drug regulations.

• Morning Rounds reports on a variety of health updates, including the release of Dr. Anthony Fauci's diaries from the COVID-19 pandemic era. • The report highlights critical concerns regarding a potential global resurgence of HIV and new data tracking substance use trends across the United States.

• A new study published in the Journal of Clinical Investigation reveals that losing specific healthy body fat can increase the risk of diabetes and fatty liver disease. • Researchers focused on familial partial lipodystrophy type 2 (FPLD2), a rare condition caused by a mutation in the lamin A/C gene that leads to fat loss in certain body areas.

• The FDA has raised concerns regarding the efficacy of Capricor Therapeutics' treatment for Duchenne muscular dystrophy ahead of an upcoming advisory committee hearing. • The agency's skepticism contradicts claims made by Capricor regarding the clinical benefits of the rare disease drug.

• FDA advisers voted to ease restrictions on popular peptides, potentially allowing specialized pharmacies to produce these compounds within the United States. • The decision comes despite agency concerns that these peptides lack the large, well-controlled human clinical trials required to establish safety and effectiveness for formal drug approval.

• Members of an FDA committee expressed concerns regarding the agency's decision to allow pharmacies to dispense certain medications without requiring traditional clinical trials. • Committee member Todd Durham, senior vice president at the Foundation Fighting Blindness, voted against adding specific peptides to the approved list.

• Researchers have identified a new compound that may enhance muscle regeneration in older adults, potentially offering a way to repair aging muscles. • In a separate study, scientists are investigating the role of GDF15 levels in determining why some women develop Hyperemesis Gravidarum (HG) while others do not.

• MannKind announced that the FDA has approved Furoscix ReadyFlow, an autoinjector form of the diuretic furosemide designed to provide IV-equivalent therapy for adults with chronic kidney disease or heart failure. • Merck agreed to permit the production of generics for alimatravir, an investigational once-monthly HIV pre-exposure prophylaxis pill, specifically for low-income nations that approve the drug.

• The United States is experiencing its highest number of measles cases in decades, driven largely by a decline in vaccination rates. • Because the vaccine was historically so effective, there has been little medical or financial incentive to develop pharmaceutical treatments for the virus.

• The Food and Drug Administration (FDA) delayed the enforcement of a critical policy intended to improve the tracking and removal of contaminated foods prior to a cyclosporiasis outbreak. • This policy failure specifically impacted the ability to monitor and recall dangerous produce, including iceberg lettuce, which is often linked to such outbreaks.