Afrigen Biologics, the South African facility that developed an mRNA vaccine from scratch during COVID-19, has become the first African facility to be certified to manufacture investigational biological products for Phase I and II clinical trials. The facility celebrated receiving its Good Manufacturing Practice (GMP) certification for its mRNA facility in Cape Town from the […] Continue reading ->
WHO emergency funds are running low, and global health leaders are concerned about a systemic paralysis in pandemic preparedness. In high-level discussions in Geneva, experts explored the geopolitical rifts, pitting the Global South’s demand to treat pandemic tools as legally binding “public goods” against a European push for market-driven surge financing. As a severe Ebola […] Continue reading ->
The World Health Organization has ‘pre-qualified’ Coartem® Baby, the first-ever malaria treatment for young infants of 4.5 kilograms or less. The combination treatment, now being rolled out in Ghana, aims to fill a longstanding gap in treatments available for children under the age of 5, who constitute three quarters of the estimated 610,000 malaria deaths […] Continue reading ->
A dispute over technology transfer rights pushed the World Health Organization (WHO) to delay its Global Action Plan on Antimicrobial Resistance (AMR) for further informal talks. Instead, the Executive Board approved a compromise drafted by Nepal and Ethiopia on Wednesday to reopen negotiations on intellectual property, specifically regarding “voluntary and mutually agreed technology transfers.” This […] Continue reading ->
Following eleven hours of intense negotiations overnight, the European Union (EU) clinched a landmark agreement on the most significant pharma reform of its medicines market in over 20 years on Thursday.  Reached in the final moments of the Danish EU Presidency’s mandate, the deal aims to strike a critical balance stimulating pharma innovation, particularly for […] Continue reading ->
The 97% cure rate for the novel compound, ganaplacide/lumefantrine in a recent Phase 3 trial offers hope for continued progress rolling back malaria even as resistance to artemisinin combination therapies (ACT) escalates.  A next-generation antimalarial drug GanLum (ganaplacide/lumefantrine, KLU156) slightly outperformed a standard of care Artemisinin Combination Therapy (ACT) in a recent Phase 3 trial […] Continue reading ->
WHO’s 2025 Essential Medicines Lists (EML), published Friday, has included the active ingredients in popular weight loss drugs like Ozempic and Wegovy –  semaglutide or other comparable  GLP-1 receptor agonists – in a recommendation that recognizes the growing importance of the drugs in clinical treatment of diabetes worldwide.  These drugs, as well as new PD-1/PD-L1 […] Continue reading ->
The World Health Organization (WHO) has designated government regulatory authorities in Canada, Japan, and the United Kingdom as WHO-Listed Authorities (WLAs), a status granted to national authorities that meet the highest international regulatory standards for medical products. The recognition widens the pool of WHO-recognized authorities significantly beyond the previously recognized authorities in Europe, the United […] Continue reading ->