Infectious Disease
FDA accepts Merck’s pneumococcal vaccine BLA for priority review
The US Food and Drug Administration (FDA) has accepted the new biologics licence application (BLA) for MSD’s investigational 21-valent pneumococcal…
Health Canada authorises Novavax’s updated Covid-19 vaccine
Health Canada has granted expanded authorisation for Novavax’s updated Covid-19 vaccine, Nuvaxovid XBB.1.5 (recombinant protein, adjuvanted) [NVX-CoV2601]. The vaccine is…
Biocon integrates Viatris biosimilars in 31 European countries
Biocon subsidiary Biocon Biologics has successfully integrated Viatris' biosimilars business in 31 countries in Europe. In November 2022, Biocon Biologics…
Japan grants approval for CSL and Arcturus’ Covid-19 vaccine
Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved CSL and Arcturus Therapeutics’ self-amplifying mRNA (sa-mRNA) Covid-19 vaccine, ARCT-154. The…
Emergent wins $75m BARDA contact for anthrax vaccine
Emergent BioSolutions has secured a $75m contract for the acquisition of the FDA-approved anthrax vaccine, Cyfendus. The contract was awarded…
Boehringer to leverage IBM’s technologies for antibody discovery
Boehringer Ingelheim has entered an agreement with IBM to leverage the latter’s foundation model technologies for novel antibody discovery and…
Japan approves Daiichi Sankyo’s Covid-19 booster vaccine
Japan’s Ministry of Health, Labour and Welfare (MHLW) has granted approval for Daiichi Sankyo’s Omicron XBB.1.5-adapted monovalent mRNA [messenger ribonucleic acid] vaccine,…
Everest Medicines gains NMPA approval in China for IgAN therapy
Everest Medicines has received approval from China's National Medical Products Administration for its therapy, Nefecon, to treat primary immunoglobulin A…
China’s NMPA approves ArkBio’s RSV neutralising antibody drug
China’s National Medical Products Administration (NMPA) has approved Shanghai Ark Biopharmaceutical’s (ArkBio) investigational new drug application for its respiratory syncytial…
SK bioscience and Hilleman to develop Ebola-Zaire virus vaccine
SK bioscience has signed an agreement with vaccines and biologics research and development organisation Hilleman Laboratories Singapore for the co-development of a…
