GSK Press Releases

• Published on July 31, 2014 - 20:32 GMT

  GSK and Genmab announce positive interim result for phase III study of ofatumumab as maintenance therapy for relapsed CLL

  Issued: 31 July 2014, London UK GlaxoSmithKline plc (LSE/NYSE: GSK) and Genmab A/S (OMX: GEN) announced today that an Independent Data Monitoring Committee (IDMC) interim analysis of a phase III study, PROLONG (OMB 112517), reached the predefined …

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• Published on July 24, 2014 - 17:18 GMT

  FDA approves Flonase allergy relief for sale over-the-counter in the United States

  Issued: Thursday 24 July 2014, London UK Parsippany, US No. 1 prescribed allergy treatment ingredient1 to be available OTC GlaxoSmithKline plc (LSE/NYSE: GSK) today announced that the U.S. Food and Drug Administration (FDA) has approved Flonase® Allergy …

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• Published on July 24, 2014 - 10:35 GMT

  GSK announces EU regulatory submission for malaria vaccine candidate RTS,S

  Issued: Thursday 24 July 2014, London UK GSK announced today that it has submitted a regulatory application to the European Medicines Agency (EMA) for its malaria vaccine candidate, RTS,S. The submission will follow the Article 58 procedure, which allows …

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• Published on July 22, 2014 - 08:52 GMT

  ViiV Healthcare presents phase III data comparing once-daily maraviroc in combination with darunavir/ritonavir with emtricitabine/...

  ViiV Healthcare today presented, at the 20th International AIDS Congress in Melbourne, Australia, the analysis of the 48-week results from the phase III MODERN study comparing maraviroc (MVC; marketed as Celsentri® /Selzentry®) dosed once daily with …

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• Published on July 17, 2014 - 13:52 GMT

  Trametinib (Mekinist™) and dabrafenib (Tafinlar™) combination demonstrated overall survival benefit compared to vemurafenib; phase ...

  GlaxoSmithKline plc (LSE/NYSE: GSK) announced today that the Independent Data Monitoring Committee (IDMC) recommended COMBI-v (MEK116513), a phase III study of its MEK inhibitor, trametinib (Mekinist™), in combination with its BRAF inhibitor, dabrafenib ( …

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• Published on July 16, 2014 - 07:19 GMT

  GSK and Theravance announce initiation of phase III programme with fixed dose triple combination treatment FF/UMEC/VI in patients ...

  GlaxoSmithKline plc (LSE/NYSE: GSK) and Theravance, Inc. (NASDAQ: THRX) today announced the start of a global phase III study, known as IMPACT, to evaluate the efficacy and safety of the ‘closed’ triple combination of FF/UMEC/VI in patients with chronic …

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• Published on July 4, 2014 - 11:49 GMT

  GSK receives EU marketing authorisation for Mekinist™ (trametinib) for patients with unresectable or metastatic melanoma with a ...

  GlaxoSmithKline plc (LSE/NYSE: GSK) today announced that the European Commission (EC) has granted marketing authorisation for Mekinist™ (trametinib) as a single agent in the treatment of adult patients with unresectable or metastatic melanoma with a BRAF …

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• Published on July 4, 2014 - 08:08 GMT

  Anoro® Ellipta® (umeclidinium/vilanterol) gains approval in Japan for the treatment of COPD

  GlaxoSmithKline plc (LSE/NYSE: GSK) and Theravance, Inc. (NASDAQ: THRX) today announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved Anoro® Ellipta® (umeclidinium/vilanterol) for the relief of various symptoms due to airway …

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• Published on July 3, 2014 - 14:50 GMT

  GSK and Genmab receive EU authorisation for Arzerra™ (ofatumumab) as first-line treatment for chronic lymphocytic leukaemia (CLL) ...

  GlaxoSmithKline plc (LSE: GSK) and Genmab A/S (OMX: GEN) announced today that the European Commission (EC) has granted marketing authorisation for a new indication for the use of Arzerra™ (ofatumumab), a human monoclonal antibody against CD20, in …

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• Published on July 2, 2014 - 16:38 GMT

  GSK statement on UK Government-initiated review of antibiotic resistance

  “We welcome today’s announcement of a review to explore the economic issues surrounding antimicrobial resistance. This is a positive step towards addressing this global public health threat. GSK has a 40 year heritage in this field and is one of only a …

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• Published on June 30, 2014 - 16:39 GMT

  GSK and Theravance announce submission to US regulatory authorities for fluticasone furoate/vilanterol in asthma

  GlaxoSmithKline plc (LSE/NYSE: GSK) and Theravance, Inc. (NASDAQ: THRX) today announced the submission of a supplemental New Drug Application (sNDA) to the US Food and Drug Administration (FDA) for a fixed dose combination of the inhaled corticosteroid, …

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• Published on June 30, 2014 - 09:06 GMT

  GSK and Save the Children offer $1 million award for healthcare innovations in developing countries that reduce child deaths

  Embargoed until:Monday 30 June 2014, London UK,00.01 - The Healthcare Innovation Award contributes to an ambitious partnership between GSK and Save the Children, which aims to save the lives of a million of the world’s poorest children GSK and Save the …

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• Published on June 27, 2014 - 20:10 GMT

  GSK and Genmab announce top-line results from a Phase III study of ofatumumab versus physicians’ choice for bulky fludarabine-...

  Issued: 27 June 2014, London UK GlaxoSmithKline plc (LSE: GSK) and Genmab A/S (OMX: GEN) announced today that the Phase III study of ofatumumab (Arzerra™) versus physicians’ choice in patients with bulky fludarabine-refractory chronic lymphocytic leukaemia …

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• Published on June 27, 2014 - 13:13 GMT

  Triumeq® (dolutegravir/abacavir/lamivudine) single-tablet regimen receives positive CHMP opinion in Europe for the treatment of ...

  ViiV Healthcare 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 Triumeq® (dolutegravir/abacavir/lamivudine) for the …

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• Published on June 25, 2014 - 10:48 GMT

  GSK announces the start of a phase III study with eltrombopag in patients with myelodysplastic syndromes

  GlaxoSmithKline plc (LSE/NYSE: GSK) today announced the start of a Phase III study, SUPPORT (TRC112121), to evaluate the platelet supportive care effects of eltrombopag (Promacta™/Revolade™) in combination with azacitidine (the current standard of care) …

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• Published on June 15, 2014 - 10:43 GMT

  GSK presents new data for once-weekly Tanzeum/Eperzan (albiglutide) showing blood glucose lowering up to three years in type 2 ...

  Issued: Saturday 14 June 2014, London New data from secondary analyses of four randomised phase III studies being presented at the 74th Scientific Sessions of the American Diabetes Association (ADA) in San Francisco show that patients enrolled in the …

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• Published on June 13, 2014 - 09:45 GMT

  GSK announces results of Phase III PETIT2 study of eltrombopag (Promacta™/Revolade™) in paediatric patients with chronic immune ...

  GlaxoSmithKline (GSK) plc today announced the results from the Phase III PETIT2 study evaluating the efficacy of eltrombopag vs. placebo in paediatric patients with chronic immune (idiopathic) thrombocytopenic purpura (cITP). Eltrombopag—marketed as …

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• Published on June 12, 2014 - 12:00 GMT

  ViiV Healthcare announces new collaboration with Janssen to investigate single-tablet regimen for maintenance treatment of HIV-1

  Agreement is ViiV Healthcare’s first external collaboration for development of a two drug single-tablet combining dolutegravir and rilpivirine London, United Kingdom, 12 June 2014 ViiV Healthcare today announced that they have entered into an agreement …

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• Published on June 11, 2014 - 13:57 GMT

  GSK and Theravance announce positive data from two studies evaluating the efficacy and safety of Incruse™ Ellipta® when added to ...

  Issued: Wednesday 11 June 2014, London, UK South San Francisco, CA, USA - LSE Announcement GlaxoSmithKline plc (LSE/NYSE:GSK) and Theravance, Inc. (NASDAQ: THRX) today announced positive results from two phase III studies, which showed that patients with …

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• Published on June 5, 2014 - 14:14 GMT

  GSK announces start of phase III cardiovascular outcomes study with losmapimod in patients with acute coronary syndrome

  Issued: Thursday 5 June 2014, London UK GlaxoSmithKline plc (LSE/NYSE: GSK) today announced the start of a pivotal phase III study, LATITUDE-TIMI 60, to evaluate the effects of losmapimod in patients presenting with acute coronary syndrome. The global, …

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