WORLD HEALTH ORGANIZATION

Eflornithine + lomustine combo showed clinically meaningful OS & PFS improvements in grade 3 IDH mutant astrocytoma patients, per Orbus Therapeutics' Phase 3 STELLAR study.

Everest Medicines presented eravacycline data at IDWeek 2024, showing broad antimicrobial activity against Carbapenem-resistant Acinetobacter baumannii and consistent efficacy against Gram-positive and Gram-negative bacteria. Eravacycline, a fluorocycline, is approved for complicated intra-abdominal infections and has shown high treatment effectiveness.

Israel’s 2021 HCV elimination program identified 865,382 at-risk persons, screened 64.3% (555,083), detected HCV in 24,361 (4.4%), and treated 80% (10,711) with 96.5% SVR. Costs were ₪14,426 ($3,606) per treated person. Targeted screening, awareness campaigns, and a patient registry were key components.

Global Biosimilars Week 2024 webinar, themed 'Advancing Access to Biosimilars,' highlights progress and challenges in biosimilar approval and adoption, focusing on streamlining regulatory requirements. Key takeaways include global trends in regulatory streamlining, strategies for improving access, and biosimilars' role in healthcare sustainability.

Tune Therapeutics' TUNE-401, an epigenetic silencer for chronic hepatitis B, received approval from New Zealand's MEDSAFE for a Phase 1b clinical trial. TUNE-401 targets HBV's cccDNA and intDNA, aiming for a functional cure by mimicking natural epigenetic repression. Pre-clinical data showed robust HBV suppression in vitro and in vivo, with durable effects beyond 550 days.

Biosimilars can improve biologic treatment access and health care sustainability in Latin America, but misconceptions, regulatory gaps, and weak pharmacovigilance hinder adoption. A multidisciplinary panel developed guidelines for biosimilar interchangeability, recommending biosimilars approved by the EMA or WHO as interchangeable, enhanced knowledge among health care professionals and patients, dedicated biosimilar regulations, strict enforcement, public access to evaluation data, robust pharmacovigilance systems, and collaboration among stakeholders.

Insud Pharma receives $2.7 million from the Bill & Melinda Gates Foundation for a Phase II trial to determine the optimal dose of sublingual oxytocin to prevent postpartum hemorrhage, aiming to save lives of over 70,000 pregnant women annually. The thermostable oxytocin tablets do not require refrigeration, making them accessible in low-resource settings. The trial, expected to start in Q1 2025, will involve 180 participants.

The personalized medicine biomarkers market is projected to grow from USD 21.95 billion in 2024 to USD 79.26 billion by 2034, at a CAGR of 13.7%. North America dominated with 52.0% of the revenue share in 2024. Oncology led with a 36.0% share, while diabetes is the fastest-growing segment, expected to grow at a CAGR of 17.4%. Technological advancements and increasing prevalence of chronic diseases drive market growth.

Researchers identified vulnerabilities in drug-resistant *M. tuberculosis* using CRISPRi, transcriptomics, and metabolomics, revealing pathways like respiration and ribosome biogenesis as targets. This approach aids in developing novel treatments for drug-resistant TB and could be applied to other resistant pathogens.

The WHO approved the Lc16m8 mpox vaccine for emergency use, the first for children aged one and older, aiming to increase timely access in outbreak areas.