HEALTH

• The FDA has fast-tracked bepirovirsen, a first-of-its-kind drug for hepatitis B, following trial results showing it may allow some patients to stop treatment entirely. • In a study of 1,838 patients receiving weekly shots for six months, approximately 20% of bepirovirsen recipients achieved a "functional cure," meaning the virus remained undetectable for six months after all medication ceased. • This is significant because current hepatitis B treatments typically require lifelong daily medication to manage the virus and prevent liver failure.

• The U.S. FDA has approved ensitrelvir (Xocova), an oral antiviral developed by Shionogi, for the post-exposure prevention of COVID-19. • The medication is authorized for use in individuals aged 12 years and older who have been exposed to the SARS-CoV-2 virus. • This approval is significant as Xocova becomes the first and only oral medication specifically authorized to reduce the risk of infection after a known exposure.

• Missouri State Rep. Dave Griffith is advocating for psychedelic-assisted therapy to treat veterans suffering from depression and post-traumatic stress disorder. • The initiative follows an April executive order signed by Donald Trump titled “Accelerating Medical Treatments for Serious Mental Illness,” which aims to speed up drug approvals and clinical trial participation. • The order directs the Secretary of Health and Human Services to allocate at least $50 million to support state governments developing programs for psychedelic drugs.

• The FDA has approved Shionogi’s Xocova (ensitrelvir) as the first oral therapy designed to prevent Covid-19 after a person has been exposed to the virus. • The approval follows the Scorpio-Pep trial involving 2,387 participants aged 12 and older who were asymptomatic but had been exposed to a symptomatic household member. • The drug works by inhibiting viral replication, offering a critical new preventative tool for those who initiate treatment within 72 hours of their contact's symptom onset.

• WHO Director General Tedros Adhanom Ghebreyesus visited health workers at the Evangelical Medical Centre in Bunia, Congo, on May 31, 2026. • The visit addresses an outbreak of the Bundibugyo virus, which is currently concentrated in Congo's eastern Ituri province. • Congo has reported over 1,000 suspected cases of the virus, a critical situation as there is currently no approved vaccine or treatment available.

• Merck (known as MSD outside the U.S. and Canada) announced the publication of new clinical trial work on May 7, 2026. • The announcement was distributed via Business Wire from Rahway, N.J., targeting both healthcare professionals and consumers. • These updates are critical for tracking new drug approvals, safety alerts, and updated indications for medical treatments.

• The FDA recently approved the oral antiviral drug ensitrelvir (Xocova) for use as post-exposure prophylaxis (PEP). • The medication is designed to be taken within 72 hours after a person has been exposed to someone with COVID-19 to prevent infection. • The Sick Times is calling on the NIH and HHS to conduct further studies on the drug to better understand its efficacy and application.

• The FDA has approved XOCOVA (ensitrelvir), developed by Shionogi Inc., as a new treatment option for COVID-19. • XOCOVA is distinguished as the first and only oral medication specifically approved to help prevent the onset of COVID-19 following exposure to the virus. • This approval expands the available pharmaceutical toolkit for infectious disease management, offering a preventative oral alternative to existing treatments.

• The FDA has approved the oral medication ensitrelvir for use as post-exposure prophylaxis (PEP) to prevent the onset of COVID-19 symptoms. • Approval follows phase 3 clinical trial data conducted between February 10 and July 10, 2022, across 92 sites in Japan, Vietnam, and South Korea, demonstrating efficacy against Omicron variants. • This development is significant as it provides a preventative option for individuals exposed to the virus in high-risk environments, including nursing homes, acute care facilities, and during travel.

• The April 24, 2026, Health Equity & Access roundup highlighted critical systemic inequities, specifically focusing on Black maternal mortality, youth impact of the 988 crisis line, and gaps in food assistance. • Medical panelists advocated for universal biomarker testing in lung cancer and the expanded use of minimal residual disease testing to improve diagnostic workflows and patient outcomes. • Experts identified significant barriers to care, including reimbursement gaps, limited access to advanced CAR T-cell therapies, and social determinants of health that hinder treatment.

• The FDA has approved ensitrelvir, an oral antiviral medication specifically designed to prevent COVID-19 after a person has been exposed to the virus. • Approval follows the phase III SCORPIO-PEP trial, which demonstrated that the drug reduced the risk of developing COVID-19 by more than half for individuals who were household contacts of an infected person. • This marks a significant shift in prevention strategy, though the medication is currently not approved for treating active COVID-19 infections within the U.S.

• Shionogi has received FDA approval for its protease inhibitor, ensitrelvir, specifically for use in the prevention of COVID-19. • This regulatory win follows a previous failure by the company to demonstrate the drug's effectiveness as a primary treatment for U.S. patients. • The approval is significant as it expands the available preventative options against the virus, leveraging a drug already approved in Japan.

• Northern Ireland’s Health Minister has praised a Public Health Agency warning regarding drug use, describing the guidance as "practical." • The statement comes amid legal proceedings where the Minister and his wife, Eleanor Donaldson of Dromore, Co Down, face criminal charges. • The Minister denies all allegations, while his wife is charged with aiding and abetting and has also denied the charges.

• During the week of June 19, 2023, the FDA issued several key approvals, including a $3.2 million gene therapy and the first anti-inflammatory drug designed for cardiovascular disease. • Other approved treatments include a subcutaneous version of Vyvgart for myasthenia gravis and the expansion of Jardiance and Synjardy for pediatric patients with type 2 diabetes. • Conversely, the agency rejected three therapies targeting nonalcoholic steatohepatitis (NASH), retinal cancer, and rare fungal infections.

• The Centers for Disease Control and Prevention (CDC) is seeking public and agency comments on a proposed continuing information collection project. • The project focuses on the "Use of the Cyclosporiasis National Hypothesis Generating Questionnaire (CNHGQ)" during investigations of foodborne disease clusters and outbreaks. • This request is part of a broader effort to maximize government information utility and reduce public burden, as mandated by the Paperwork Reduction Act of 1995.

• Researchers are analyzing the current debate regarding the construction of layperson summaries for clinical trial results within the European Union. • The authors propose a "reader-centered" approach that prioritizes the most critical information for patients, specifically the efficacy and safety of the drug. • This method argues that the investigational medicinal products and overall trial results should be presented first to provide the primary rationale for the reader.

• WHO advisory groups have selected several candidates for clinical trial evaluation during the current outbreak response, including remdesivir, Maftivimab®, and vaccine candidates rVSV and ChAdOx1 Bundibugyo. • New research highlights durable results from PCSK9 base-editing (VERVE-102) and examines the impact of GLP-1 agonists like semaglutide on health outcomes. • Experts clarified that Deet remains effective for real-world use, noting that certain conditioning effects were limited to laboratory settings and may not reflect typical application patterns.

• Following the resignation of Commissioner Marty Makary, the FDA is seeking a new leader to oversee the agency's commitment to accelerating treatment access for rare disease patients. • The urgency is highlighted by UX111 gene therapy, which clinical trials show can reduce toxin buildup for over eight years and slow cognitive decline if administered early. • This transition is critical because children unable to access UX111 through clinical trials continue to suffer irreversible losses while awaiting formal FDA approval.