GSK receives approval for Incruse™ Ellipta® (umeclidinium) in the US for the treatment of COPD
GlaxoSmithKline plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has approved Incruse™ Ellipta® (umeclidinium) as an anticholinergic indicated for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. (Source: GSK news)
Source: GSK news - April 30, 2014 Category: Pharmaceuticals Source Type: news
Results announcement for the first quarter 2014
Q1 turnover £5.6 billion, -2% (CER) on an ex-divestment* basis. (Source: GSK news)
Source: GSK news - April 30, 2014 Category: Pharmaceuticals Source Type: news
GSK announces start of phase III programme for mepolizumab in patients with COPD
GlaxoSmithKline plc (LSE/NYSE: GSK) today announced the start of a phase III programme to evaluate the efficacy and safety of mepolizumab as an adjunctive therapy for adults who have severe chronic obstructive pulmonary disease (COPD). (Source: GSK news)
Source: GSK news - April 29, 2014 Category: Pharmaceuticals Source Type: news
GSK receives EU marketing authorisation for Incruse (umeclidinium) for the treatment of COPD
GlaxoSmithKline plc (LSE/NYSE: GSK) announced today that the European Commission has granted marketing authorisation for Incruse® (umeclidinium) as a once-daily, maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD). (Source: GSK news)
Source: GSK news - April 28, 2014 Category: Pharmaceuticals Source Type: news
GSK and MMV announce start of phase III programme of tafenoquine for Plasmodium vivax malaria
GlaxoSmithKline (GSK) and Medicines for Malaria Venture (MMV) today announced the start of a phase III global programme to evaluate the efficacy and safety of tafenoquine, an investigational medicine which is being developed for the treatment and relapse prevention (radical cure) of Plasmodium vivax (P. vivax) malaria. (Source: GSK news)
Source: GSK news - April 28, 2014 Category: Pharmaceuticals Source Type: news
GSK receives positive CHMP opinion for Mekinist™ (trametinib) in metastatic melanoma with a BRAF V600 mutation
GlaxoSmithKline plc (LSE/NYSE: GSK) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending marketing authorisation for Mekinist™ (trametinib) as a single agent in the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation. (Source: GSK news)
Source: GSK news - April 25, 2014 Category: Pharmaceuticals Source Type: news
GSK plc announces major three-part transaction with Novartis to drive sustainable sales growth, improve long-term earnings and deliver increasing returns to shareholders
GlaxoSmithKline plc today announces a major three-part inter-conditional transaction with Novartis AG involving its Consumer Healthcare, Vaccines and Oncology businesses (Source: GSK news)
Source: GSK news - April 22, 2014 Category: Pharmaceuticals Source Type: news
GSK and Theravance announce phase III study of fluticasone furoate/vilanterol in COPD commenced to support potential future filing in Japan
GlaxoSmithKline (LSE/NYSE: GSK) and Theravance, Inc. (NASDAQ: THRX) today announced the start of a Phase III efficacy and safety study of a combination treatment of the inhaled corticosteroid (ICS), fluticasone furoate and long-acting beta2 agonist (LABA), vilanterol (FF/VI). (Source: GSK news)
Source: GSK news - April 22, 2014 Category: Pharmaceuticals Source Type: news
GSK and Genmab receive FDA approval for Arzerra® (ofatumumab) as first-line treatment in combination with chlorambucil for patients with Chronic Lymphocytic Leukaemia (CLL) for whom fludarabine-based therapy is considered inappropriate
GlaxoSmithKline plc (LSE: GSK) and Genmab A/S (OMX: GEN) announced today that the U.S. Food and Drug Administration (FDA) has approved a Supplemental Biologic License Application (sBLA) for the use of Arzerra® (ofatumumab), a CD20-directed cytolytic monoclonal antibody, in combination with chlorambucil for the treatment of previously untreated patients with chronic lymphocytic leukaemia (CLL) for whom fludarabine-based therapy is considered inappropriate. (Source: GSK news)
Source: GSK news - April 17, 2014 Category: Pharmaceuticals Source Type: news
GSK announces approval in Canada for Incruse Ellipta (umeclidinium) as a treatment for COPD
GlaxoSmithKline plc (LSE/NYSE: GSK) today announced that Incruse™ Ellipta™ (umeclidinium, as umeclidinium bromide) has received market authorisation in Canada for the long-term once-daily maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. (Source: GSK news)
Source: GSK news - April 17, 2014 Category: Pharmaceuticals Source Type: news
GSK statement on media reports
There has been recent publicity on cases of alleged misconduct by GSK employees in a number of countries. This is a result of details of these cases being made available to the media (Source: GSK news)
Source: GSK news - April 16, 2014 Category: Pharmaceuticals Source Type: news
GSK receives US approval for once-weekly type 2 diabetes treatment, Tanzeum™ (albiglutide)
GlaxoSmithKline plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has approved TanzeumTM (albiglutide) for injection, for subcutaneous use, as a once-weekly treatment for type 2 diabetes. (Source: GSK news)
Source: GSK news - April 15, 2014 Category: Pharmaceuticals Source Type: news
GSK receives US approval for once-weekly type 2 diabetes treatment, TanzeumTM (albiglutide)
GlaxoSmithKline plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has approved TanzeumTM (albiglutide) for injection, for subcutaneous use, as a once-weekly treatment for type 2 diabetes. (Source: GSK news)
Source: GSK news - April 15, 2014 Category: Pharmaceuticals Source Type: news
GSK statement on BBC Panorama programme
GSK issued the following statement in response to claims by BBC Panorama related to GSK in Poland, to be broadcast on Monday April 14 2014 (Source: GSK news)
Source: GSK news - April 14, 2014 Category: Pharmaceuticals Source Type: news
Update on phase III clinical trial of investigational MAGE-A3 antigen-specific cancer immunotherapeutic in non-small cell lung cancer
GSK announced its decision to stop the MAGRITi trial, a Phase III trial of its MAGE-A3ii cancer immunotherapeuticiii in non-small cell lung cancer (NSCLC) patients, after establishing that it will not be possible to identify a sub-population of gene-signature positive NSCLC patients that may benefit from the treatment. (Source: GSK news)
Source: GSK news - April 2, 2014 Category: Pharmaceuticals Source Type: news
