Cyclospora Outbreak Linked to Iceberg Lettuce in 9 States | Cyclosporiasis

• Merck has received FDA approval for Lipfendra, the first oral pill in the PCSK9 inhibitor class of cholesterol-lowering medications. • Unlike traditional PCSK9 inhibitors that require injections, Lipfendra is a macrocyclic peptide specifically designed for oral administration.

• The Food and Drug Administration (FDA) announced a new outbreak of cyclosporiasis that has sickened at least 72 people. • The agency posted the update to its official website late Wednesday, though it has not yet identified the specific location of the outbreak.

• An FDA advisory panel narrowly voted to recommend allowing compounding pharmacies to produce BPC-157 and KPV, two popular but unproven peptides. • The decision follows advocacy from Robert F. Kennedy Jr., who pushed for increased access to these substances despite their lack of formal FDA approval.

• An FDA advisory panel began a two-day meeting on Thursday to review more than six types of peptides currently used in wellness trends. • These substances are under scrutiny because there is little scientific evidence to prove they are safe or effective for human use.

• An FDA advisory panel is meeting this week to determine if compounding pharmacies should be permitted to offer seven synthetic peptides. • The panel must weigh whether regulated compounding pharmacies provide a safer alternative to the "gray-market" versions currently used by enthusiasts.

• Recent outbreaks of measles in the US, Cyclosporiasis, and Ebola in Africa are spreading at unprecedented levels, exposing critical vulnerabilities in global public health infrastructure. • The resurgence of measles in the US has reached record levels, primarily driven by vaccine hesitancy and declining vaccination rates that have eroded herd immunity.

• An FDA advisory committee is set to review evidence regarding peptides to determine if they should be approved for legal compounding. • Experts have expressed concern over a lack of sufficient evidence to support the safety and efficacy of compounding these substances.

• Health officials have launched an investigation into a second cyclosporiasis outbreak as cases of the diarrhea-causing illness continue to rise. • Authorities are currently working to identify the specific food source, though historical outbreaks have been linked to imported produce like raspberries, cilantro, and basil from Latin America.

• A multistate outbreak of cyclosporiasis, a parasite causing severe diarrhea, has spread across 41 U.S. states. • Health officials have linked the surge in cases to contaminated shredded lettuce, with specific mentions of products used at Taco Bell.

• Morning Rounds reports on several critical health updates, including the legal and administrative status of service members who refused the Covid-19 vaccine. • The briefing highlights a current Ebola outbreak, which is described as the fastest-growing in history, signaling an urgent public health crisis.

• The FDA is currently reviewing the regulatory status and future of peptides, while companies like RevMed and GSK have received new approvals. • Repligen has expanded its cell therapy capabilities through a $1.5 billion acquisition deal for BioLife.