GlaxoSmithKline plc

GSK announces positive headline results from the pivotal DREAMM-2 study

GlaxoSmithKline plc (LON/NYSE: GSK) today announced positive headline results from the pivotal DREAMM-2 open-label, randomised study of two doses of belantamab mafodotin (GSK2857916). The 196 patients in the trial had relapsed multiple myeloma, were refractory to an immunomodulatory drug, a proteasome inhibitor, and to treatment with an anti-CD38 antibody. The two-arm study met its primary objective and demonstrated a clinically …

GlaxoSmithKline plc

GlaxoSmithKline PLC ViiV results positive for every 2 month injection

GlaxoSmithKline PLC (LON: GSK) ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, today announced positive headline results from its global phase III ATLAS-2M study of the investigational, long-acting, injectable, 2-drug regimen (2DR) of ViiV Healthcare’s cabotegravir and Janssen’s rilpivirine for the treatment of HIV. The study was designed to …

GSK completes transaction with Pfizer to form new world-leading Consumer Healthcare Joint Venture

GlaxoSmithKline plc (LON:GSK) today announced that it has completed its transaction with Pfizer to combine their consumer healthcare businesses into a world-leading Joint Venture. GSK has a controlling equity interest of 68% and Pfizer has an equity interest of 32% in the Joint Venture. The Joint Venture brings together two highly complementary portfolios of trusted consumer health brands, including GSK’s …

GlaxoSmithKline plc

GlaxoSmithKline PLC ViiV submits cabotegravir to EMA for HIV injection

ViiV Healthcare submits regulatory application to European Medicines Agency for investigational cabotegravir to be used in combination with rilpivirine as the first monthly, injectable treatment for HIV The marketing application is based on phase III ATLAS and FLAIR pivotal trials in which the once-monthly, injectable treatment regimen showed similar efficacy and safety to daily, 3-drug oral treatment. ViiV Healthcare, the …

GlaxoSmithKline plc

GlaxoSmithKline PLC positive headline results in Phase 3 PRIMA study

GlaxoSmithKline plc (LON/NYSE: GSK) has today announced positive results from PRIMA (ENGOT-OV26/GOG-3012), the Phase 3 randomized, double-blind, placebo-controlled, study of ZEJULA (niraparib) as a maintenance therapy in patients with first-line ovarian cancer following platinum-based chemotherapy. The study met its primary endpoint of a statistically significant improvement in progression free survival for women regardless of their biomarker status. The safety and …

GlaxoSmithKline PLC ViiV switch study shows 2DR as effective as 3DR

ViiV Healthcare, the global specialist HIV company majority-owned by GlaxoSmithKline plc (LON: GSK), with Pfizer Inc. (NYSE: PFE) and Shionogi Limited as shareholders, today announced positive Week 48 results from its phase III TANGO study. The TANGO study was conducted to assess whether adults living with HIV-1 who had maintained viral suppression for at least six months on a tenofovir …

GlaxoSmithKline plc

GlaxoSmithKline PLC Gains FDA approval for Nucala self-administration

GlaxoSmithKline plc (LON: GSK) has today announced that the US Food and Drug Administration has approved two new methods for administering Nucala (mepolizumab), an autoinjector and a pre-filled safety syringe, for patients or caregivers to administer once every four weeks, after a healthcare professional decides it is appropriate. This is the first anti-IL5 biologic to be licensed in the US …

GlaxoSmithKline plc

GlaxoSmithKline Plc CHMP positive on GSK’s Nucala self-administration

GlaxoSmithKline Plc (LON/NYSE: GSK) today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending two new methods for administering Nucala (mepolizumab) to patients with severe eosinophilic asthma: a pre-filled pen and a pre-filled safety syringe, to be taken once every four weeks. If approved, the two new Nucala …

GlaxoSmithKline plc

GlaxoSmithKline PLC Delivers sales of £7.7 billion +6% AER, +5% CER

GlaxoSmithKline PLC (LON:GSK) today announced 1st quarter results 2019 Financial highlights · Pharmaceuticals sales £4.2 billion, +4% AER, +2% CER; Vaccines £1.5 billion, +23% AER, +20% CER; Consumer Healthcare £2.0 billion, flat AER, +1% CER. · Total Group operating margin 18.6%. Adjusted Group operating margin 28.2%, +1.6 percentage points AER, +1.0 percentage point CER (Pharmaceuticals 29.8%; Vaccines 40.3%; Consumer Healthcare …

GlaxoSmithKline ViiV Healthcare New Drug Application to US FDA

ViiV Healthcare, the global specialist HIV company majority owned by GlaxoSmithKline PLC (LON:GSK), with Pfizer Inc. and Shionogi Limited as shareholders, today submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) seeking approval for the investigational, monthly, injectable, two-drug regimen of ViiV Healthcare’s cabotegravir and Janssen’s rilpivirine to treat HIV-1 infection in adults whose viral …