GSK and Genmab announce positive interim result for phase III study of ofatumumab as maintenance therapy for relapsed CLL
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 significance level for efficacy (p≤0.001). The interim analysis demonstrated that treatment with ofatumumab (Arzerra™) met the primary endpoint of improving progression free survival (PFS). The study evaluated ofatumumab maintenance therapy versus no further treatment (observation) in patients with relapsed chronic lymphocytic leukaemia (CLL) who responded to treatment at relapse. (Source: GSK news)
Source: GSK news - July 31, 2014 Category: Pharmaceuticals Source Type: news

FDA approves Flonase allergy relief for sale over-the-counter in the United States
No. 1 prescribed allergy treatment ingredient1 to be available OTC (Source: GSK news)
Source: GSK news - July 24, 2014 Category: Pharmaceuticals Source Type: news

GSK announces EU regulatory submission for malaria vaccine candidate RTS,S
GSK announced today that it has submitted a regulatory application to the European Medicines Agency (EMA) for its malaria vaccine candidate, RTS,S. (Source: GSK news)
Source: GSK news - July 24, 2014 Category: Pharmaceuticals Source Type: news

Results announcement for the second quarter 2014
GSK delivers Q2 2014 turnover £5.6 billion (-4%) and core EPS 19.1p (-12%) on ex-divestment basis (both CER). Q2 dividend 19p (+6%). (Source: GSK news)
Source: GSK news - July 23, 2014 Category: Pharmaceuticals Source Type: news

ViiV Healthcare presents phase III data comparing once-daily maraviroc in combination with darunavir/ritonavir with emtricitabine/tenofovir plus darunavir/ritonavir in treatment-naïve adults with HIV-1
An investigational two drug-regimen of maraviroc dosed once daily, combined with darunavir/ritonavir (DRV/r) showed inferior efficacy compared to emtricitabine/tenofovir (FTC/TDF) with DRV/r. (Source: GSK news)
Source: GSK news - July 22, 2014 Category: Pharmaceuticals Source Type: news

Trametinib (Mekinist™) and dabrafenib (Tafinlar™) combination demonstrated overall survival benefit compared to vemurafenib; phase III BRAF V600-mutant metastatic melanoma study stopped early
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 (Tafinlar™), compared to vemurafenib in patients with BRAF V600E or V600K mutation-positive unresectable or metastatic cutaneous melanoma be stopped early. (Source: GSK news)
Source: GSK news - July 17, 2014 Category: Pharmaceuticals Source Type: news

GSK and Theravance announce initiation of phase III programme with fixed dose triple combination treatment FF/UMEC/VI in patients with COPD
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 obstructive pulmonary disease (COPD). (Source: GSK news)
Source: GSK news - July 16, 2014 Category: Pharmaceuticals Source Type: news

GSK receives EU marketing authorisation for Mekinist™ (trametinib) for patients with unresectable or metastatic melanoma with a BRAF V600 mutation
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 V600 mutation. (Source: GSK news)
Source: GSK news - July 4, 2014 Category: Pharmaceuticals Source Type: news

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). (Source: GSK news)
Source: GSK news - July 4, 2014 Category: Pharmaceuticals Source Type: news

GSK and Genmab receive EU authorisation for Arzerra™ (ofatumumab) as first-line treatment for chronic lymphocytic leukaemia (CLL) in combination with chlorambucil or bendamustine for patients ineligible for fludarabine-based therapy
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™. (Source: GSK news)
Source: GSK news - July 3, 2014 Category: Pharmaceuticals Source Type: news

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... (Source: GSK news)
Source: GSK news - July 2, 2014 Category: Pharmaceuticals Source Type: news

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). (Source: GSK news)
Source: GSK news - June 30, 2014 Category: Pharmaceuticals Source Type: news

GSK and Save the Children offer $1 million award for healthcare innovations in developing countries that reduce child deaths
GSK and Save the Children today announced the launch of their second annual $1 million Healthcare Innovation Award at the Partnership for Maternal, Newborn and Child Health meeting in South Africa. (Source: GSK news)
Source: GSK news - June 30, 2014 Category: Pharmaceuticals Source Type: news

GSK and Genmab announce top-line results from a Phase III study of ofatumumab versus physicians’ choice for bulky fludarabine-refractory CLL
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 (CLL) did not meet its primary endpoint of progression free survival (PFS). The median PFS, as assessed by the Independent Review Committee, was 5.36 months for ofatumumab and 3.61 months for physicians’ choice (Hazard Ratio 0.79, p=0.267). (Source: GSK news)
Source: GSK news - June 27, 2014 Category: Pharmaceuticals Source Type: news

Triumeq® (dolutegravir/abacavir/lamivudine) single-tablet regimen receives positive CHMP opinion in Europe for the treatment of HIV
ViiV Healthcare’s first investigational once-daily single-tablet regimen, combining the integrase inhibitor dolutegravir and nucleoside analogues abacavir/lamivudine (Source: GSK news)
Source: GSK news - June 27, 2014 Category: Pharmaceuticals Source Type: news

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™). (Source: GSK news)
Source: GSK news - June 25, 2014 Category: Pharmaceuticals Source Type: news

GSK presents new data for once-weekly Tanzeum/Eperzan (albiglutide) showing blood glucose lowering up to three years in type 2 diabetes
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 (Source: GSK news)
Source: GSK news - June 14, 2014 Category: Pharmaceuticals Source Type: news

GSK announces results of Phase III PETIT2 study of eltrombopag (Promacta™/Revolade™) in paediatric patients with chronic immune thrombocytopenia
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 Promacta™ in the U.S. and as Revolade™ in Europe and other countries across the world—met its primary endpoint. (Source: GSK news)
Source: GSK news - June 13, 2014 Category: Pharmaceuticals Source Type: news

ViiV Healthcare announces new collaboration with Janssen to investigate single-tablet regimen for maintenance treatment of HIV-1
ViiV Healthcare today announced that they have entered into an agreement with Janssen R&D Ireland Ltd (Janssen) for the development and commercialisation of a single-tablet combining dolutegravir (Tivicay) and Janssen’s non-nucleoside reverse transcriptase inhibitor rilpivirine (Edurant). (Source: GSK news)
Source: GSK news - June 12, 2014 Category: Pharmaceuticals Source Type: news

GSK and Theravance announce positive data from two studies evaluating the efficacy and safety of Incruse™ Ellipta® when added to Relvar®/Breo® Ellipta® in patients with COPD
GlaxoSmithKline plc (LSE/NYSE:GSK) and Theravance, Inc. (NASDAQ: THRX) today announced positive results from two phase III studies (Source: GSK news)
Source: GSK news - June 11, 2014 Category: Pharmaceuticals Source Type: news

GSK announces start of phase III cardiovascular outcomes study with losmapimod in patients with acute coronary syndrome
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. (Source: GSK news)
Source: GSK news - June 5, 2014 Category: Pharmaceuticals Source Type: news

GSK announces Phase III ALTTO results for anti-HER2 therapy combination in the adjuvant breast cancer treatment setting
GlaxoSmithKline plc (LSE: GSK) today announced that the Phase III study of two anti-HER2 agents, lapatinib (Tykerb™/Tyverb™) and trastuzumab, did not meet the primary endpoint of improved disease free survival (DFS) compared to single agent therapy with trastuzumab as adjuvant treatment for HER2 positive early breast cancer (Source: GSK news)
Source: GSK news - June 1, 2014 Category: Pharmaceuticals Source Type: news

Serious Fraud Office Investigation
GlaxoSmithKline plc (LSE/NYSE: GSK) has today been informed by the UK’s Serious Fraud Office (SFO) that it has opened a formal criminal investigation into the Group’s commercial practices. (Source: GSK news)
Source: GSK news - May 27, 2014 Category: Pharmaceuticals Source Type: news

GSK and Genmab receive CHMP positive opinion for Arzerra (ofatumumab) in combination with chlorambucil or bendamustine as a first-line treatment for patients with chronic lymphocytic leukaemia (CLL) who are not eligible for fludarabine-based therapy
GlaxoSmithKline plc (LSE: GSK) and Genmab A/S (OMX: GEN) announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending a variation to the terms of the marketing authorisation for Arzerra™ (ofatumumab) for a new indication in combination with chlorambucil or bendamustine for the treatment of patients with chronic lymphocytic leukaemia (CLL) who have not received prior therapy and who are not eligible for fludarabine-based therapy. (Source: GSK news)
Source: GSK news - May 23, 2014 Category: Pharmaceuticals Source Type: news

GSK announces regulatory submission for umeclidinium monotherapy for COPD in Japan
GSK announced the submission of a regulatory application to the Japanese MHLW for UMEC a LAMA, administered using the Ellipta™ dry powder inhaler. (Source: GSK news)
Source: GSK news - May 23, 2014 Category: Pharmaceuticals Source Type: news

GSK announces new commitment to improve access to vaccines with 5-year price freeze for countries graduating from GAVI Alliance support
GSK announced today that it will freeze the prices of its vaccines for five years for developing countries that graduate from GAVI Alliance support. (Source: GSK news)
Source: GSK news - May 20, 2014 Category: Pharmaceuticals Source Type: news

GSK presents positive data at ATS 2014 from study evaluating efficacy and safety of Incruse™ Ellipta® added to Advair® Diskus® in patients with COPD
In this study the safety and efficacy of the addition of a long-acting muscarinic antagonist (also known as an anticholinergic), umeclidinium ‘UMEC’ 62.5mcg (IncruseTM Ellipta®) and UMEC 125mcg, to the inhaled corticosteroid and long-acting beta2 agonist combination medicine, fluticasone proprionate and salmeterol ‘FSC 250/50 mcg’ (Advair ® Diskus®), was evaluated in chronic obstructive pulmonary disease (COPD) patients over 12 weeks. (Source: GSK news)
Source: GSK news - May 19, 2014 Category: Pharmaceuticals Source Type: news

GSK and Genmab announce top-line results from a pivotal head-to-head study of ofatumumab in combination with chemotherapy vs. rituximab in combination with chemotherapy for the treatment of relapsed or refractory diffuse large b-cell lymphoma
GlaxoSmithKline plc (LSE: GSK) and Genmab A/S (OMX: GEN) announced today that the Phase III study (ORCHARRD) of ofatumumab (Arzerra™) plus chemotherapy versus rituximab plus chemotherapy to treat relapsed or refractory diffuse large B-cell lymphoma (DLBCL) did not meet its primary endpoint as there was no statistically significant difference in progression free survival (PFS) between the treatment arms. (Source: GSK news)
Source: GSK news - May 19, 2014 Category: Pharmaceuticals Source Type: news

GSK announces phase III study with darapladib did not meet primary endpoint in patients following an acute coronary syndrome
GlaxoSmithKline (LSE/NYSE: GSK) today announced headline results from its second phase III study with darapladib, SOLID-TIMI 52, evaluating the efficacy of its investigational Lp-PLA2 inhibitor in adults following an acute coronary syndrome. (Source: GSK news)
Source: GSK news - May 13, 2014 Category: Pharmaceuticals Source Type: news

Anoro® (umeclidinium/vilanterol) gains marketing authorisation in Europe for the treatment of COPD
GlaxoSmithKline plc (LSE/NYSE: GSK) and Theravance, Inc. (NASDAQ: THRX) today announced that the European Commission has granted marketing authorisation for Anoro®. (Source: GSK news)
Source: GSK news - May 8, 2014 Category: Pharmaceuticals Source Type: news

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

ViiV Healthcare announces new initiatives to improve access to dolutegravir: licence to the Medicines Patent Pool
ViiV Healthcare today announced new collaborations with the goal of increasing access to its HIV medicine, dolutegravir (marketed under the name Tivicay®), just two months after its approval by the European Medicines Agency (EMA) and eight months after approval by the US Food and Drug Administration (FDA). (Source: GSK news)
Source: GSK news - April 1, 2014 Category: Pharmaceuticals Source Type: news

Results from phase III patient preference study of GSK’s Votrient® (pazopanib) vs. Sutent® (sunitinib) in advanced renal cell carcinoma published in Journal of Clinical Oncology
Data from the first patient preference study in advanced renal cell carcinoma have been published in the Journal of Clinical Oncologyi. (Source: GSK news)
Source: GSK news - April 1, 2014 Category: Pharmaceuticals Source Type: news

Regulatory update: Votrient® (pazopanib) as maintenance therapy for advanced ovarian cancer in the EU
GlaxoSmithKline plc (LSE/NYSE: GSK) today announced that it has withdrawn its application to the European Medicines Agency (EMA) for a variation to the Marketing Authorisation for Votrient® (pazopanib). (Source: GSK news)
Source: GSK news - March 31, 2014 Category: Pharmaceuticals Source Type: news

GSK announces new strategic investments in Africa to increase access to medicines, build capacity and deliver sustainable growth
GSK today announced a series of new investments in sub-Saharan Africa designed to address pressing health needs and contribute to long-term business growth. (Source: GSK news)
Source: GSK news - March 31, 2014 Category: Pharmaceuticals Source Type: news

GSK presents data from Phase III STABILITY study of darapladib in patients with chronic coronary heart disease
GlaxoSmithKline plc (LSE/NYSE: GSK) today presented data from the pivotal Phase III STABILITY study of darapladib at the American College of Cardiology 63rd Annual Scientific Session in Washington, DC (Source: GSK news)
Source: GSK news - March 30, 2014 Category: Pharmaceuticals Source Type: news