Human Genome Sciences

Human Genome Sciences
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Human Genome Sciences

 •  December 20, 2016

First injectable to be studied for efficacy in pre-exposure prophylaxis Issued: London ViiV Healthcare, the global specialist HIV company majority-owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, today announced the start of a phase III study to evaluate long-acting injectable cabotegravir for the prevention of HIV infection....

Human Genome Sciences

 •  December 13, 2016

Issued: London UK GSK today announced the submission of a regulatory application to the Japanese Ministry of Health, Labour and Welfare (MHLW) for belimumab, in adult patients with active, autoantibody-positive systemic lupus erythematosus (SLE) who have an inadequate response to standard therapy. Belimumab is a human monoclonal antibody that...

Human Genome Sciences

 •  November 25, 2016

Issued: 25 November 2016, London UK GlaxoSmithKline plc (LSE/NYSE: GSK) today announced the regulatory submission of a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) seeking approval for its candidate shingles vaccine, ShingrixTM, for the prevention of herpes zoster (shingles) in people aged 50 years or over. The...

Human Genome Sciences

 •  November 24, 2016

Issued: London GlaxoSmithKline plc (LSE/NYSE: GSK) today announced the start of a phase III development programme investigating daprodustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), as a treatment for anaemia associated with chronic kidney disease (CKD). The phase III programme includes two studies evaluating the...

Human Genome Sciences

 •  November 19, 2016

GSK [LSE/NYSE: GSK] announced today it has received approval from the US Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research expanding the indication for FluLaval® Quadrivalent (Influenza Vaccine) to include use in children 6 months and older. Prior to this, the vaccine was only approved for active immunization...

Human Genome Sciences

 •  November 18, 2016

Issued: London Studies will investigate monthly dosing with injectable cabotegravir and rilpivirine ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, today announced the start of two phase III studies designed to evaluate an investigational long-acting, injectable...

Human Genome Sciences

 •  November 17, 2016

Issued: London GlaxoSmithKline plc (LSE/NYSE: GSK) today announced results from two pivotal phase III studies evaluating subcutaneous sirukumab, a human anti-interleukin (IL)-6 monoclonal antibody in development for the treatment of adults with moderately to severely active rheumatoid arthritis (RA). The first study (SIRROUND-T), in patients who...

Human Genome Sciences

 •  November 17, 2016

Issued: Washington DC, USA and London, UK Results from 7-year Phase III continuation study in US patients GSK today announced results from a 7-year safety and efficacy continuation study for Benlysta® (belimumab) in patients with active, autoantibody-positive systemic lupus erythematosus (SLE). The data being presented at the 2016 American College...

Human Genome Sciences

 •  November 14, 2016

Data in Japan, China and South Korea will form basis of new regulatory submissions for Benlysta GSK today announced positive efficacy and safety data from a pivotal study of patients with systemic lupus erythematosus (SLE) in Northeast Asia (Japan, China and South Korea). In the study, being presented at the 2016 American College of...

Human Genome Sciences

 •  October 27, 2016

- New studies support flexible dosing and co-administration with flu vaccine Issued: London GSK today announced new data for its shingles candidate vaccine ShingrixTM, at the Infectious Disease Week (IDWeek) scientific conference in New Orleans, Louisiana, USA. The data examined co-administration of GSK’s candidate vaccine with the flu vaccine; a...