ViiV Healthcare submits New Drug Application to US FDA for single-tablet, two-drug regimen of dolutegravir and lamivudine for treatment of HIV
Priority review voucher used with NDA submission with anticipated target action date of six months
We are updating our policy on working with healthcare professionals (HCPs). This policy update is being made to ensure we continue to operate responsibly and improve how we help prescribers to understand new data and clinical experience with our innovative products, so they can deliver better outcomes for patients.
GSK and the Duke Clinical Research Institute (DCRI) today announced publication of positive results from the Harmony Outcomes study which assessed the cardiovascular (CV) safety and efficacy of albiglutide, a GLP-1 receptor agonist, in patients with type 2 diabetes and cardiovascular disease. Results were presented at the European Association for the Study of Diabetes congress 2018 with simultaneous publication in The Lancet.[i]
GSK candidate vaccine helps prevent active pulmonary tuberculosis in HIV negative adults in phase II study
Publication of primary results in the New England Journal of Medicine shows positive impact of innovative vaccine technology in clinical trial conducted in tuberculosis endemic regions.
GlaxoSmithKline plc (LSE/NYSE: GSK) and Innoviva, Inc. (NASDAQ: INVA) announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion today supporting the use of Trelegy Ellipta (fluticasone furoate/umeclidinium/ vilanterol ‘FF/UMEC/VI’) in a broader group of patients with moderate to severe chronic obstructive pulmonary disease (COPD) and that labelling, if approved, will be updated to further reflect its effect on exacerbations of COPD.
ViiV Healthcare submits regulatory application to European Medicines Agency for single-tablet, two-drug regimen of dolutegravir and lamivudine for treatment of HIV
ViiV Healthcare today announced submission of a marketing authorisation application (MAA) to the European Medicines Agency (EMA) for a single-tablet, two-drug regimen of dolutegravir (DTG) and lamivudine (3TC) for the treatment of HIV-1 infection.
GSK announces results of indirect treatment comparisons of Nucala to benralizumab and reslizumab for severe eosinophilic asthma
Nucala demonstrated greater reduction in exacerbations and improved asthma control.
GlaxoSmithKline plc (GSK) will profile the growing evidence base that supports its broad respiratory medicines portfolio at the European Respiratory Society (ERS) congress in Paris, France, 15-19 September 2018.