GSK announces regulatory submission for umeclidinium monotherapy in European Union
GlaxoSmithKline plc (LSE:GSK) today announced the submission of a regulatory application in the European Union for the investigational once-daily medicine, umeclidinium bromide (UMEC), for patients with chronic obstructive pulmonary disease (COPD). (Source: GSK news)
Source: GSK news - April 26, 2013 Category: Pharmaceuticals Source Type: news
Results announcement for the first quarter 2013
GSK delivers Q1 2013 core EPS of 26.9p and dividend of 18p (Source: GSK news)
Source: GSK news - April 24, 2013 Category: Pharmaceuticals Source Type: news
GSK and Theravance announce regulatory submission for ANORO™ ELLIPTA™ (UMEC/VI) in Japan
GlaxoSmithKline plc (GSK) and Theravance, Inc. (NASDAQ: THRX) today announced the submission of a regulatory application to the Japanese Ministry of Health, Labour and Welfare (MHLW) for the investigational once-daily LAMA/LABA combination medicine, UMEC/VI, for patients with chronic obstructive pulmonary disease (COPD). (Source: GSK news)
Source: GSK news - April 22, 2013 Category: Pharmaceuticals Source Type: news
GSK statement in response to OFT Statement of Objections
GSK supports fair competition and we very strongly believe that we acted within the law, as the holder of valid patents for paroxetine, in entering the agreements under investigation. (Source: GSK news)
Source: GSK news - April 19, 2013 Category: Pharmaceuticals Source Type: news
FDA Advisory Committee recommends approval of BREO(TM) ELLIPTA(TM) for the treatment of COPD
GlaxoSmithKline plc (LSE: GSK) and Theravance, Inc. (NASDAQ: THRX) today announced that the Pulmonary-Allergy Drugs Advisory Committee (PADAC) to the US Food and Drug Administration (FDA) voted that the efficacy and safety data provide substantial evidence to support approval of BREO™ ELLIPTA™ as a once-daily inhaled treatment for the long-term, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD) (9 for, 4 against) and also for the reduction of COPD exacerbations in patients with a history of exacerbations (9 for, 4 against)*. (Source: GSK news)
Source: GSK news - April 17, 2013 Category: Pharmaceuticals Source Type: news
GlaxoSmithKline announces start of phase III study of Benlysta® (belimumab ) in patients with vasculitis
GlaxoSmithKline plc (GSK) today announced the start of a Phase III study to evaluate Benlysta® (belimumab) in patients with ANCA (Anti-neutrophil Cytoplasmic Antibodies) positive vasculitis – a condition that involves inflammation of the blood vessels. (Source: GSK news)
Source: GSK news - April 3, 2013 Category: Pharmaceuticals Source Type: news
GSK announces first four-strain seasonal influenza vaccine granted marketing authorisation in Germany and the UK
GlaxoSmithKline plc has announced the marketing authorisation of its quadrivalent (four-strain) influenza vaccine in Germany and the UK. (Source: GSK news)
Source: GSK news - April 3, 2013 Category: Pharmaceuticals Source Type: news
Regulatory update: GlaxoSmithKline receives complete response from FDA for candidate pandemic H5N1 adjuvanted influenza vaccine
GlaxoSmithKline [NYSE:GSK] announced today that it has received a Complete Response letter from the U.S. Food and Drug Administration (FDA) in response to the Biologics License Application (BLA) for its Pandemic Influenza A Virus Monovalent Adjuvanted candidate vaccine, referred to as Q-Pan H5N1. (Source: GSK news)
Source: GSK news - March 25, 2013 Category: Pharmaceuticals Source Type: news
GSK publishes 2012 Corporate Responsibility report
Report sets out 23 forward-looking commitments to help measure future performance (Source: GSK news)
Source: GSK news - March 20, 2013 Category: Pharmaceuticals Source Type: news
$500,000 Endowment Gift from The GlaxoSmithKline Foundation Expands Program to Help Patients with Cancer and their Families at The Children’s Hospital of Philadelphia
Donation Will Enable Patients and Families with Limited Financial Means to Benefit from
Cutting-Edge Cancer Research and Treatments at Children’s Hospital (Source: GSK news)
Source: GSK news - March 18, 2013 Category: Pharmaceuticals Source Type: news
Young scientists challenged by GSK and McLaren to help drive science behind Formula 1™
GSK and the McLaren Group announce new science education initiative to inspire young people into science and engineering careers (Source: GSK news)
Source: GSK news - March 13, 2013 Category: Pharmaceuticals Source Type: news
Regulatory update – GSK announces regulatory submission for albiglutide in Europe
GlaxoSmithKline plc (GSK) today announced the submission of a Marketing Authorisation Application (MAA) for albiglutide, with the proprietary name EPERZAN, to the European Medicines Agency (EMA). (Source: GSK news)
Source: GSK news - March 7, 2013 Category: Pharmaceuticals Source Type: news
ViiV Healthcare presents data from Phase III study of dolutegravir vs raltegravir in treatment-experienced adults with HIV-1
ViiV Healthcare presents 24-week interim results from Phase III SAILING study at the 20th Conference on Retroviruses and Opportunistic Infections (CROI) (Source: GSK news)
Source: GSK news - March 6, 2013 Category: Pharmaceuticals Source Type: news
ViiV Healthcare announces a voluntary licence agreement with the Medicines Patent Pool to increase access to HIV medicines for children
Agreement brings the number of voluntary licences granted by ViiV Healthcare to 14. (Source: GSK news)
Source: GSK news - February 27, 2013 Category: Pharmaceuticals Source Type: news
GSK and Theravance announce FDA acceptance of New Drug Application (NDA) submission in the US for ANORO ELLIPTATM for COPD
(Source: GSK news)
Source: GSK news - February 19, 2013 Category: Pharmaceuticals Source Type: news
