The US Food and Drug Administration (FDA) has granted Priority Review to GSK’s respiratory syncytial virus (RSV) older adult vaccine candidate with a decision expected in May 2023: which could make it the first vaccine approved against the virus.
The US Food and Drug Administration (FDA) has approved GSK’s Priorix (Measles, Mumps and Rubella Vaccine, Live) for individuals 12 months of age and older.
GlaxoSmithKline plc (GSK) says the US Food and Drug Administration (FDA) has approved its anti-IL-5 biologic Nucala (mepolizumab) in a 40 mg pre-filled syringe for children aged 6 to 11 years old with severe eosinophilic asthma (SEA).
A single booster dose of Sanofi and GSK’s recombinant adjuvanted COVID-19 vaccine candidate delivered ‘consistently strong immune responses’, according to data released by the companies.
The Oxford-GSK Institute of Molecular and Computational Medicine has been created via a five-year collaboration between GlaxoSmithKline and the University of Oxford.
The World Health Organization is recommending widespread use of the RTS,S/AS01 (RTS,S) vaccine among children in sub-Saharan Africa and other regions with moderate to high malaria transmission.
GSK will help manufacture up to 60 million doses of Novavax’s COVID-19 vaccine from its facility at Barnard Castle in the UK, with doses to be distributed in the country.
Sanofi and GSK have initiated a new Phase 2 study for their COVID-19 vaccine candidate; with a Phase 3 study set to follow in Q2 and potential rollout of the vaccine in Q4.
Sanofi’s vaccine manufacturing plant in Marcy l’Etoile, France, will formulate and fill vials of Janssen’s COVID-19 vaccine: producing around 12 million doses a month to help address global supply demands.
In 2020, GSK and Vir Biotechnology partnered to research and develop therapies for coronaviruses. This agreement has now been extended to include new therapies for influenza and other respiratory viruses, with GSK investing $345m in the extended partnership.
GlaxoSmithKline has started dosing patients in a Phase 3 clinical program investigating the safety and efficacy of its Respiratory Syncytial Virus (RSV) candidate vaccine for maternal immunisation.
GSK taps Lyell’s technology to delay ‘exhaustion’ of T cells and will explore creating a new platform to develop cell and gene therapies for rare cancers.
US FDA approves AstraZeneca’s at-home autoinjector for administration of an add-on treatment for severe asthma, matching the indication of GSK’s rival product, Nucala.
GSK has announced a shakeup of its UK network, shelving plans for Ulverston biopharma plant, mooting the sale of its cephalosporin antibiotics business and pledging to invest in HIV and respiratory drug capacity.
