LONDON: GSK plc (LSE/NYSE: GSK) and Spero Therapeutics, Inc. (Nasdaq: SPRO) today announced they have entered into an exclusive licence agreement for tebipenem pivoxil hydrobromide (tebipenem HBr), a late-stage antibiotic being developed by Spero, as the first oral carbapenem antibiotic to potentially treat complicated urinary tract infections (cUTI), including pyelonephritis, caused by certain bacteria. Luke…
Tag: GSK
GSK announces positive pivotal phase III data for its respiratory syncytial virus (RSV) vaccine candidate
LONDON: GSK plc (LSE/NYSE: GSK) announced positive headline results from a pre-specified efficacy interim analysis of the AReSVi 006 phase III trial. The interim analysis was reviewed by an Independent Data Monitoring Committee, and the primary endpoint was exceeded with no unexpected safety concerns observed. AReSVi 006 is a phase III trial investigating GSK’s respiratory…
GSK announces US FDA approval of Priorix
LONDON: GSK plc announced that the US Food and Drug Administration (FDA) has approved Priorix (Measles, Mumps and Rubella Vaccine, Live) for active immunisation for the prevention of measles, mumps and rubella (MMR) in individuals 12 months of age and older. Priorix is currently licenced in more than 100 countries worldwide, including all European countries,…
GSK Cervarix two-dose schedule approved by NMPA
LONDON: GSK plc (LSE/NYSE: GSK) announced today that a two-dose schedule for its HPV vaccine Cervarix [Human Papillomavirus bivalent (types 16, 18) Vaccine, Recombinant)] has been approved by China’s NMPA for girls aged 9 to 14. With this approval, Cervarix is the first imported two-dose HPV vaccine for this age group in mainland China. The…
GlaxoSmithKline to acquire California based Sierra Oncology
LONDON, UK: GlaxoSmithKline plc (LSE: GSK) and Sierra Oncology Inc (Nasdaq: SRRA) have entered into an agreement under which GSK will acquire Sierra Oncology, a California-based, late-stage biopharmaceutical company focused on targeted therapies for the treatment of rare forms of cancer, for $55 per share of common stock in cash representing an approximate total equity…
EMA accepts GSK’s marketing authorisation application for daprodustat
LONDON: GlaxoSmithKline plc (NYSE: GSK) announced that the European Medicines Agency (EMA) validated the marketing authorisation application (MAA) for daprodustat, an investigational oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), for the treatment of patients with anaemia of chronic kidney disease (CKD). Daprodustat was developed based upon the unique Nobel Prize-winning science that demonstrated how cells…