Oncology

Malaysia calls for phase 4 Dengvaxia study before considering full approval Already struggling to meet initial expectations, Sanofi Pasteur's dengue vaccine Dengvaxia will have to undergo phase 4 testing in Malaysia before the endemic country agrees to sign off on a full approval. Malaysia’s National Pharmaceutical Regulatory Agency’s Drug Control Authority, which conditionally approved the vaccine, said in a notice that if the study fails to verify the clinical benefit, DCA may withdraw Dengvaxia's registration. The French vaccine maker will conduct the two-year trial jointly with the country’s Ministry of Health, aiming to further assess the vaccine’s effectiveness a...