Tag Archives: GSK

GSK: US FDA VRBPAC’s vote brings us one step closer to approval of Shingrix

LONDON, 14-Sep-2017 — /EuropaWire/ — GlaxoSmithKline plc [LSE/NYSE: GSK] announced today that the Vaccines and Related Biological Products Advisory Committee (VRBPAC) of the US Food and Drug Administration (FDA) voted unanimously that the data support the efficacy and safety of Shingrix … Read the full press release

GSK: Benlysta plus standard of care prolonged control of disease activity in patients with active systemic lupus erythematosus (SLE)

Final efficacy and safety results from phase II continuation study Madrid, Spain and London, UK, 19-Jun-2017 — /EuropaWire/ — GSK today announced results from a 10-year continuation study, which showed that Benlysta (belimumab) plus standard of care prolonged control of disease … Read the full press release

Relieve the Stress from Asthma Management with New MyAsthma App

NOTTINGHAM, 18-Apr-2017 — /EuropaWire/ — A new and unique smartphone app to help people with asthma manage their condition has been developed by lung experts at the Nottingham Respiratory Research Unit and the pharmaceutical company GlaxoSmithKline (GSK). The MyAsthma app has been launched … Read the full press release

ViiV Healthcare’s phase III programme starts to support regulatory filings for two-drug regimen of dolutegravir and lamivudine as a treatment for HIV-1

LONDON, 22-Aug-2016 — /EuropaWire/ — ViiV Healthcare today announced the start of a phase III programme to support regulatory filings for a two-drug regimen of dolutegravir (Tivicay®) and lamivudine (Epivir®) as a treatment for HIV-1 infection in adults who have not … Read the full press release

Oncology study: GSK starts phase I clinical trial with an investigational inducibile T-cell costimulator (ICOS) agonist antibody

GSK3359609 is the first investigational ICOS agonist antibody to enter human clinical trials LONDON, 01-Jul-2016 — /EuropaWire/ — GSK today announced the start of a phase I clinical trial with GSK3359609, an investigational inducibile T-cell costimulator (ICOS) agonist antibody. ICOS is … Read the full press release

University of Cambridge / GSK: Human genetics can support the development of new therapies

An approach that could reduce the chances of drugs failing during the later stages of clinical trials has been demonstrated by a collaboration between the University of Cambridge and pharmaceutical company GlaxoSmithKline (GSK).  CAMBRIDGE, 02-Jun-2016 — /EuropaWire/ — The technique involves … Read the full press release

Japanese Ministry of Health, Labour and Welfare (MHLW) granted approval for GSK’s Nucala® as a treatment for bronchial asthma

LONDON, 29-Mar-2016 — /EuropaWire/ — GlaxoSmithKline plc (LSE/NYSE:GSK) today announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has granted approval for Nucala® (mepolizumab) as a treatment for bronchial asthma in patients with refractory asthma whose symptoms are inadequately … Read the full press release

Kuehne + Nagel to run the core business of transporting products from the raw materials supplier to trade customers for GlaxoSmithKline (GSK)

London / UK, Schindellegi / CH, 13-1-2016 — /EuropaWire/ — Kuehne + Nagel and GSK signed an end-to-end global logistics partnership until 2021 that will see Kuehne + Nagel run the core business of transporting products from the raw materials … Read the full press release

HIV-1: ViiV Healthcare formalised its collaboration with Janssen Sciences Ireland UC

LONDON, 11-1-2016 — /EuropaWire/ — ViiV Healthcare, a global specialist HIV company with GSK, Pfizer Inc. and Shionogi Limited as shareholders, today formalised its collaboration with Janssen Sciences Ireland UC (Janssen) for the phase III investigation and commercialisation of the … Read the full press release

GSK further strengthens and expands its vaccines presence in US by establishing new global centre for vaccines R&D in Rockville, Maryland

New hub based in Rockville, MD expands GSK’s global vaccines R&D footprint London and Philadelphia, 6-4-2015 — /EuropaWire/ — GSK announced today it is further strengthening and expanding its vaccines presence in the US by establishing a new global centre … Read the full press release

GSK announces the winners of its second Discovery Fast Track Challenge

14 proposals selected from 428 entries in 26 countries Project areas include HIV, cancer and neurodegeneration LONDON, 4-12-2014 — /EuropaWire/ — GSK has announced the winners of its second Discovery Fast Track Challenge – a programme designed to combine the … Read the full press release

GSK submits variation to the Marketing Authorisation for eltrombopag (Revolade™) to the European Medicines Agency (EMA)

LONDON, 13-11-2014 — /EuropaWire/ — GSK today announced the submission to the European Medicines Agency (EMA) of a variation to the Marketing Authorisation for eltrombopag (Revolade™), seeking an additional indication for the treatment of adult patients with severe aplastic anaemia … Read the full press release

The European Medicines Agency gives scientific advice to GSK on its development plan for an Ebola vaccine

Developers encouraged to request accelerated procedure for scientific advice LONDON, 30-10-2014 — /EuropaWire/ — The European Medicines Agency (EMA) has given scientific advice to GSK on its development plan for an Ebola vaccine. This is the first time in the … Read the full press release

GSK: Stiefel to start phase III study of subcutaneous ofatumumab in patients with rare autoimmune skin disorder pemphigus vulgaris

LONDON, 9-10-2014 — /EuropaWire/ — Stiefel, a GSK company, today announced the start of a phase III study to evaluate the efficacy and safety of subcutaneous ofatumumab in patients with pemphigus vulgaris, a rare autoimmune skin disorder. The global study … Read the full press release

GSK presented data at European Respiratory Society Congress that show blood eosinophil levels may help inform COPD treatment decisions

LONDON, 10-9-2014 — /EuropaWire/ — GSK today presented data at the European Respiratory Society (ERS) Congress that show blood eosinophil levels may help predict those patients with COPD who will have a greater reduction in exacerbation rates when receiving an … Read the full press release

GSK announces £5m collaboration with UK and South African Medical Research Councils to support research into non-communicable diseases in Africa

LONDON, 10-9-2014 — /EuropaWire/ — GSK today announced a £5m collaboration with the UK and South African Medical Research Councils, to support much-needed research into non-communicable diseases (NCDs) in Africa, as part of GSK’s Africa NCD Open Lab initiative. The … Read the full press release

GlaxoSmithKline plc received FDA Breakthrough Therapy designation for its Tafinlar® (dabrafenib)

Marks GSK’s fourth Breakthrough Therapy designation London, UK, 17-1-2014 — /EuropaWire/ —  GlaxoSmithKline plc (LSE: GSK) announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for Tafinlar®(dabrafenib) for treatment of patients with metastatic BRAF V600E … Read the full press release

GlaxoSmithKline submitted NDA to US FDA for the once daily inhaled corticosteroid (ICS) treatment, fluticasone furoate (FF), administered using the ELLIPTA™ dry powder inhaler

London, UK, 23-10-2013 — /EuropaWire/ — 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. The NDA … Read the full press release

GSK and Pfizer owned ViiV Healthcare announced US regulatory submission for STR combining dolutegravir with abacavir and lamivudine for people living with HIV

London, UK, 23-10-2013 — /EuropaWire/ — 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. This New Drug … Read the full press release

GSK President Europe, Japan, Emerging Markets & Asia Pacific Abbas Hussain issued statement on the meeting with Chinese Ministry of Public Security

22-7-2013 — /EuropaWire/ — Following a meeting with the Chinese Ministry of Public Security to discuss their investigation into GSK, Abbas Hussain, President International – Europe, Japan, Emerging Markets & Asia Pacific said: “We have had a very constructive meeting with the … Read the full press release