A new three-dose vial presentation of the maternal RSV vaccine received prequalification from the World Health Organization (WHO) on Wednesday, unlocking large-scale distribution across lower-income countries. The decision enables global health alliances to introduce affordable immunisation during pregnancy, protecting newborns from severe respiratory disease. Respiratory syncytial virus (RSV) remains the second leading cause of infant […] Continue reading ->
The United States has unlocked frozen Gavi funding, resolving a bitter political impasse in Washington while doubling down against the WHO. But can the alliance eliminate thimerosal, a mercury-containing preservative, from its stockpiles without leaving millions of vulnerable children unprotected? The United States will immediately release $600 million for fiscal years 2025–2026 in frozen Gavi […] Continue reading ->
HPV vaccines have transformed cervical cancer prevention, but the next generation of vaccines must better reflect regional disease patterns, including the HPV35 genotype prevalent in Africa.   The recent WHO Global Status Report on Cancer paints a sobering picture. Among the many challenges, human papillomavirus, or HPV, is one of the world’s most serious infectious causes of […] Continue reading ->
A stark debate over who owns the data in the future of AI and digital health emerged at the World Health Organization (WHO) Executive Board on Wednesday. Low and middle-income countries warned that the rapid deployment of new technologies risks accelerating data extraction and increasing inequality, cautioning that – without strict AI governance, sustainable financing […] Continue reading ->
The European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) have jointly established new AI principles in drug development to reduce regulatory divergence between the major markets of the European Union and the United States. Industry associations have applauded the landmark accord, as it strengthens harmonisation across the regions – but emphasise […] 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 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 ->
The World Health Organization’s (WHO) vast European region – 53 countries, including the entire European Union, Russia and even Israel – is often excluded from cheaper medicine deals because of member states’ high- and middle-income status. But one of the flagship programmes of WHO regional director Dr Hans Kluge is the Novel Medicines Platform (NMP), […] Continue reading ->
WHO has expanded its list of trusted national regulatory authorities from three to 36 agencies – including the United States Food and Drug Adminstration (FDA), the European Medicines Agency (EMA) as well as the European Medicines Regulatory Network (EMRN), composed of the European Commission, and thirty national regulatory agencies. The WHO Listed Authorities (WLAs) are […] Continue reading ->