GSK receives positive CHMP opinion for REVOLADE in thrombocytopenia associated with chronic hepatitis C infection
Today, GlaxoSmithKline plc (GSK) announced a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommending marketing authorisation for REVOLADETM (eltrombopag). (Source: GSK news)
Source: GSK news - July 26, 2013 Category: Pharmaceuticals Source Type: news
GSK receives positive CHMP opinion for REVOLADETM in thrombocytopenia associated with chronic hepatitis C infection
Today, GlaxoSmithKline plc (GSK) announced a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommending marketing authorisation for REVOLADETM (eltrombopag). (Source: GSK news)
Source: GSK news - July 26, 2013 Category: Pharmaceuticals Source Type: news
Results announcement for the second quarter 2013
GSK announces Q2 core EPS growth of 4% and dividend of 18p (Source: GSK news)
Source: GSK news - July 24, 2013 Category: Pharmaceuticals Source Type: news
Update on GSK Consumer Nigeria plc Scheme of Arrangement
GlaxoSmithKline plc (“GSK”) (LSE:GSK) and GlaxoSmithKline Consumer Nigeria PLC (“GSK Nigeria”) today announced that they have agreed that the scheme of arrangement proposed to GSK Nigeria’s shareholders in the scheme document dated 24 June 2013, under which it was proposed that GSK would increase its indirect ownership in GSK Nigeria to 75%, will be withdrawn. (Source: GSK news)
Source: GSK news - July 22, 2013 Category: Pharmaceuticals Source Type: news
GSK statement regarding recent meeting with Chinese authorities
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 made the following statement. (Source: GSK news)
Source: GSK news - July 22, 2013 Category: Pharmaceuticals Source Type: news
GSK response to China investigation
In response to the ongoing investigations by government authorities in China regarding our business in the country, GSK has issued the following statement. (Source: GSK news)
Source: GSK news - July 15, 2013 Category: Pharmaceuticals Source Type: news
Regulatory update: fluticasone furoate/vilanterol submission in Japan
GlaxoSmithKline (GSK) and Theravance, Inc. (NASDAQ: THRX) today announced that the licence application for the use of fluticasone furoate (FF) and vilanterol (VI) (proposed brand name RELVARTM ELLIPTATM) in patients with chronic obstructive pulmonary disease (COPD) has been withdrawn from the current Japanese New Drug Application (JNDA) (Source: GSK news)
Source: GSK news - July 12, 2013 Category: Pharmaceuticals Source Type: news
Regulatory update – GSK announces US submission for dabrafenib/trametinib combination in metastatic melanoma
GlaxoSmithKline (GSK) plc today announced submission of supplemental New Drug Applications (NDAs) to the US Food and Drug Administration for use of dabrafenib, a BRAF inhibitor, in combination with trametinib, a MEK inhibitor. (Source: GSK news)
Source: GSK news - July 9, 2013 Category: Pharmaceuticals Source Type: news
Regulatory Update - GSK receives positive CHMP opinions for Tafinlar® (dabrafenib) and Tyverb® (lapatinib)
Today, GlaxoSmithKline plc (GSK) announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) is recommending marketing authorisation for two cancer drugs. (Source: GSK news)
Source: GSK news - June 28, 2013 Category: Pharmaceuticals Source Type: news
GlaxoSmithKline’s drisapersen (previously GSK2402968/PRO051) to receive Food and Drug Administration Breakthrough Therapy designation for potential treatment of patients with Duchenne Muscular Dystrophy
Breakthrough Therapy designation is one of several programmes created by the FDA to expedite the development and review of drugs for serious or life-threatening conditions. (Source: GSK news)
Source: GSK news - June 27, 2013 Category: Pharmaceuticals Source Type: news
GSK and Save the Children launch $1 million award to discover new healthcare innovations for reducing child deaths
The Healthcare Innovation Award is the first joint initiative announced following the launch of an ambitious new partnership between GSK and Save the Children (Source: GSK news)
Source: GSK news - June 27, 2013 Category: Pharmaceuticals Source Type: news
GSK announces data from five Phase III studies of albiglutide, an investigational once-weekly treatment for type 2 diabetes
Data from five long-term Phase III studies (Harmony 1 to 5) comparing albiglutide, an investigational glucagon-like peptide receptor agonist (GLP-1), to placebo and a range of active comparators were presented at the American Diabetes Association Meeting (ADA) in Chicago (21-25th June). The active comparators in the studies were insulin, a sulphonylurea (SU), a thiazolidinedione (TZD), and a dipeptidyl peptidase four inhibitor (DPP-4). (Source: GSK news)
Source: GSK news - June 24, 2013 Category: Pharmaceuticals Source Type: news
GSK receives offer for its thrombosis brands and related manufacturing site
GlaxoSmithKline (LSE: GSK) has today received an offer for its thrombosis brands and Notre-Dame de Bondeville (NDB) site from Aspen Global Incorporated and Aspen Pharmacare Holdings Limited. (Source: GSK news)
Source: GSK news - June 18, 2013 Category: Pharmaceuticals Source Type: news
GSK statement regarding 2010 Nature Medicine study
GSK and Nature Medicine recently became aware of allegations of misrepresentation of data in a research paper written by scientists at GSK’s China research centre and published in Nature Medicine in 2010. (Source: GSK news)
Source: GSK news - June 10, 2013 Category: Pharmaceuticals Source Type: news
GSK statement in response to FDA Advisory Committee’s vote on availability of Avandia (rosiglitazone)
GlaxoSmithKline [NYSE: GSK] confirmed today that a joint advisory committee to the U.S. Food and Drug Administration (FDA) voted to continue to make Avandia (rosiglitazone) available to appropriate patients with the majority of the members voting to either modify (13) or remove (7) the Risk Evaluation and Mitigation Strategy (REMS) program in place. Remaining members voted to continue the REMS (5) or withdraw (1) Avandia from the US market. (Source: GSK news)
Source: GSK news - June 6, 2013 Category: Pharmaceuticals Source Type: news
