GSK to create a new Centre of Excellence for Sustainable Chemistry in Brazil
GSK today announced it has formed a new collaboration with the São Paulo Research Foundation (FAPESP) to create a new Centre of Excellence for Sustainable Chemistry in Brazil. (Source: GSK news)
Source: GSK news - October 25, 2013 Category: Pharmaceuticals Source Type: news
Results announcement for the third quarter 2013
GSK announces Q3 core EPS growth of 16% and dividend of 19p (Source: GSK news)
Source: GSK news - October 23, 2013 Category: Pharmaceuticals Source Type: news
GSK announces US regulatory submission for fluticasone furoate monotherapy for asthma
GlaxoSmithKline plc (LSE:GSK) today announced the submission of a New Drug Application (NDA) in the US for the once daily inhaled corticosteroid (ICS) treatment, fluticasone furoate (FF), administered using the ELLIPTA™ dry powder inhaler. (Source: GSK news)
Source: GSK news - October 23, 2013 Category: Pharmaceuticals Source Type: news
ViiV Healthcare announces US regulatory submission for a single-tablet regimen combining dolutegravir with abacavir and lamivudine for people living with HIV
ViiV Healthcare today announced the submission of a regulatory application in the United States for its investigational single-tablet regimen (STR) combining dolutegravir, abacavir and lamivudine for the treatment of people living with HIV-1. (Source: GSK news)
Source: GSK news - October 22, 2013 Category: Pharmaceuticals Source Type: news
Regulatory update – GSK and Genmab announce submission to US regulatory authorities for Arzerra® (ofatumumab) as 1st line treatment of Chronic Lymphocytic Leukaemia (CLL)
GlaxoSmithKline plc [LSE/NYSE: GSK] and Genmab A/S [OMX: GEN] announced today the submission of a supplemental Biologics License Application (sBLA) to the US Food and Drug Administration (FDA) for the use of Arzerra® (ofatumumab) in combination with an alkylator-based therapy, to be used for treatment of CLL patients who have not received prior treatment and are inappropriate for fludarabine-based therapy. (Source: GSK news)
Source: GSK news - October 18, 2013 Category: Pharmaceuticals Source Type: news
Malaria vaccine candidate reduces disease over 18 months of follow-up in late-stage study of more than 15,000 infants and young children
Multilateral Initiative on Malaria Pan African Conference, Durban, South Africa — Results from a large-scale Phase III trial, presented today in Durban, show that the most clinically advanced malaria vaccine candidate, RTS,S, continued to protect young children and infants from clinical malaria up to 18 months after vaccination. Based on these data, GSK now intends to submit, in 2014, a regulatory application to the European Medicines Agency (EMA). The World Health Organization (WHO) has indicated that a policy recommendation for the RTS,S malaria vaccine candidate is possible as early as 2015 if it is granted a posi...
Source: GSK news - October 8, 2013 Category: Pharmaceuticals Source Type: news
Regulatory update – GSK and Genmab announce European submission to regulatory authorities for Arzerra® (ofatumumab) as 1st line treatment of Chronic Lymphocytic Leukaemia (CLL)
GlaxoSmithKline plc and Genmab A/S [OMX: GEN] announced today the submission of a variation to the Marketing Authorisation to the European Medicines Agency (EMA) for the use of Arzerra (ofatumumab) in combination with an alkylator-based therapy, to be used for treatment of CLL patients who have not received prior treatment and are inappropriate for fludarabine-based therapy. (Source: GSK news)
Source: GSK news - October 4, 2013 Category: Pharmaceuticals Source Type: news
GlaxoSmithKline reaches agreement with Aspen to divest thrombosis brands and related manufacturing site for £0.7 billion
Divestment supports strategic focus and delivery of pipeline. (Source: GSK news)
Source: GSK news - September 30, 2013 Category: Pharmaceuticals Source Type: news
GSK and Barclays form partnership to increase access to healthcare and promote economic development in Zambia
GlaxoSmithKline (GSK) and Barclays have formed a new partnership which aims to increase access to affordable healthcare and medicines for people in Zambia, while helping to create improved economic conditions for growth. (Source: GSK news)
Source: GSK news - September 27, 2013 Category: Pharmaceuticals Source Type: news
GSK receives marketing authorisation from the European Commission for additional Revolade™ (eltrombopag) indication as the first approved treatment for chronic hepatitis C-associated thrombocytopenia
GlaxoSmithKline plc announced today that the European Commission has granted an additional indication for Revolade™ (eltrombopag) as a treatment for low platelet counts (thrombocytopenia) in adult patients with chronic hepatitis C infection. (Source: GSK news)
Source: GSK news - September 24, 2013 Category: Pharmaceuticals Source Type: news
GSK and Prosensa announce primary endpoint not met in Phase III study of drisapersen in patients with Duchenne Muscular Dystrophy
GlaxoSmithKline (GSK) and Prosensa today announced that GSK’s Phase III clinical study of drisapersen, an investigational antisense oligonucleotide, for the treatment of Duchenne Muscular Dystrophy (DMD) patients with an amenable mutation, did not meet the primary endpoint. (Source: GSK news)
Source: GSK news - September 20, 2013 Category: Pharmaceuticals Source Type: news
RELVAR™ ELLIPTA™ gains approval in Japan for the treatment of asthma
GlaxoSmithKline plc (LSE/NYSE: GSK) and Theravance, Inc. (NASDAQ: THRX) today announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved RELVAR™ ELLIPTA™ for the treatment of bronchial asthma. (Source: GSK news)
Source: GSK news - September 20, 2013 Category: Pharmaceuticals Source Type: news
RELVAR™ ELLIPTA™ receives positive opinion from the CHMP in Europe for the treatment of asthma and COPD
GlaxoSmithKline plc (LSE/NYSE: GSK) and Theravance, Inc. (NASDAQ: THRX) today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending marketing authorisation for fluticasone furoate/vilanterol (FF/VI) under the proposed brand name RELVAR™ ELLIPTA™ for; (Source: GSK news)
Source: GSK news - September 19, 2013 Category: Pharmaceuticals Source Type: news
GSK signs a multi-year agreement with BARDA to supply the US government with anthrax treatment
GlaxoSmithKline (GSK) plc today announced a new four year contract with the Biomedical Advanced Research and Development Authority (BARDA), part of the US Department of Health and Human Services (HHS), for the provision of its inhalation anthrax treatment, raxibacumab. (Source: GSK news)
Source: GSK news - September 19, 2013 Category: Pharmaceuticals Source Type: news
GSK receives Priority Review from FDA for dabrafenib/trametinib combination in metastatic melanoma
GlaxoSmithKline plc (LSE:GSK) today announced that the US Food and Drug Administration (FDA) has granted Priority Review designation to its supplemental New Drug Applications (sNDAs) for combined use of Tafinlar® (dabrafenib) and Mekinist® (trametinib) for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 E or K mutation (Source: GSK news)
Source: GSK news - September 16, 2013 Category: Pharmaceuticals Source Type: news
