WORLD HEALTH ORGANIZATION

The mpox outbreak has prompted a global research effort, leveraging lessons from Covid-19 to accelerate vaccine and treatment development. Challenges include vaccine availability and treatment access, particularly in Africa. Adaptive trial designs and streamlined regulatory processes from Covid-19 are aiding mpox research, but financing and infrastructure remain barriers, especially in affected regions.

The FDA authorized Apple's hearing aid software for second-gen AirPods Pro, making it the first OTC hearing aid software. A clinical study showed self-fitting achieved similar benefits as professional fitting. New features include Hearing Protection mode and a Hearing Test for personalized audio profiles. This could reduce stigma and costs for hearing loss protection, impacting 1.5 billion people globally.

Gilead's twice-yearly lenacapavir for HIV prevention showed 96% efficacy reduction in HIV infections, surpassing daily Truvada in Phase 3 trials. The company aims to ensure broad, sustainable access in high-incidence, resource-limited countries, pursuing a robust voluntary licensing program. Regulatory filings for lenacapavir for PrEP are planned by end of 2024, with a focus on high-incidence, low-resource countries. Pricing for lenacapavir for PrEP is yet to be determined, with a commitment to access pricing in high-incidence, resource-limited countries.

Lenacapavir, an HIV treatment, reduced infection risk by 96% in a Phase 3 trial, proving 89% more effective than Truvada. The trial's success led to early unblinding, allowing all participants access to lenacapavir. Gilead plans to use trial data for drug approval in multiple countries by year-end, prioritizing high-incidence, low-resource regions.

Liraglutide (Saxenda) is safe and effective for children aged 6-12 in reducing BMI, per SCALE Kids trial results presented at EASD. Published in NEJM, the study shows a 7.4% BMI reduction compared to placebo, with improvements in blood pressure and blood sugar control. Liraglutide, a GLP-1 receptor agonist, is the first to be studied for pediatric obesity treatment.

Heersink School of Medicine awarded nine staff members the 2024 Dean’s Excellence Awards for Staff, recognizing their exceptional contributions to education, clinical care, and research.

Europe approves sotatercept (Winrevair; Merck) as a combination treatment for pulmonary arterial hypertension (PAH) in World Health Organization Functional Class II to III patients, following FDA approval. Based on the Phase 3 STELLAR trial, sotatercept improved exercise capacity, reduced risk of death or clinical worsening, and improved functional class. The drug, a first activin signaling inhibitor, is administered subcutaneously every 3 weeks.

Sylvester Comprehensive Cancer Center, part of the University of Miami Miller School of Medicine, implements five initiatives to improve health equity in gynecological care, including cervical cancer prevention, global health education, mapping cancer genes, clinical trial access, and using big data to target disease burden.