Merck strikes voluntary licensing deals in poor countries for an experimental HIV prevention pill

• On 28 April 2026, the Medicines and Healthcare products Regulatory Agency (MHRA) and the Health Research Authority introduced the most significant package of clinical trial reforms in over 20 years. • The legislative changes aim to accelerate the setup of low-risk trials and streamline the process for making modifications to existing studies.

• A diarrhea bug outbreak has expanded to four additional states, while Dr. Anthony Fauci is scheduled to testify before Congress. • In legislative developments, momentum is growing for the creation of a dedicated office of men's health within the Department of Health and Human Services (HHS).

• A Washington Post investigation published July 24, 2026, reveals significant regulatory gaps in how U.S. states oversee medspas and the sale of peptide injections. • The report found that wellness clinics selling amino acid chains for weight loss and longevity often face less oversight and fewer inspections than local restaurants or hair salons.

• An FDA advisory committee voted to expand access to four peptides, including KPV, despite the agency's warnings regarding a lack of clinical evidence for their efficacy. • The FDA specifically noted that there is no human clinical data to support using KPV for wound healing or inflammatory conditions like psoriasis, eczema, and ulcerative colitis.

• New York City health officials are currently investigating an outbreak of Legionnaires’ disease that has resulted in multiple deaths and dozens of illnesses. • Medical professionals are issuing guidance to the public on specific preventative measures to reduce the risk of exposure to the bacteria.

• Ipsen announced that its drug Bylvay failed to meet the primary objective in a late-stage clinical trial for biliary atresia, a rare liver disease in infants. • The study failed to demonstrate that Bylvay improved native liver survival rates when compared to a placebo.

• A multistate outbreak of Cyclospora has been linked to the consumption of iceberg lettuce across nine U.S. states. • Health officials are tracking cyclosporiasis cases and urging affected individuals to report symptoms to their local health departments.

• 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.