GSK announces submission to U.S. regulatory authorities for Promacta™ (eltrombopag) for severe aplastic anaemia
GlaxoSmithKline plc (LSE:GSK) announced today the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for Promacta™ (eltrombopag). (Source: GSK news)
Source: GSK news - February 28, 2014 Category: Pharmaceuticals Source Type: news
GSK kicks off 2014 Discovery Fast Track Challenge for academic drug hunters in Europe, Canada and USA
GSK is inviting academic scientists to enter their most innovative drug research proposals into its 2014 Discovery Fast Track Challenge. (Source: GSK news)
Source: GSK news - February 25, 2014 Category: Pharmaceuticals Source Type: news
GSK receives positive CHMP opinion for Incruse® (umeclidinium) for the treatment of COPD
GlaxoSmithKline plc (LSE/NYSE: GSK) 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 umeclidinium under the proposed brand name Incruse® as a once-daily, maintenance treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD). (Source: GSK news)
Source: GSK news - February 20, 2014 Category: Pharmaceuticals Source Type: news
Anoro® (umeclidinium / vilanterol) receives positive opinion from the CHMP in Europe for the treatment of 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 umeclidinium/vilanterol (UMEC/VI) under the proposed brand name Anoro® (Source: GSK news)
Source: GSK news - February 20, 2014 Category: Pharmaceuticals Source Type: news
GSK announces start of Phase lll study for mepolizumab in patients with Eosinophilic Granulomatosis with Polyangiitis
GlaxoSmithKline (GSK) today announced the start of a Phase III study to evaluate the efficacy and safety of mepolizumab, an investigational IL-5 antagonist. (Source: GSK news)
Source: GSK news - February 14, 2014 Category: Pharmaceuticals Source Type: news
Results announcement for fourth quarter 2013
GSK announces core EPS of 112.2p and dividend of 78p. (Source: GSK news)
Source: GSK news - February 5, 2014 Category: Pharmaceuticals Source Type: news
GSK gains FDA Breakthrough Therapy designation for Promacta®/Revolade® (eltrombopag) for severe aplastic anaemia
GlaxoSmithKline plc (LSE:GSK) announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for Promacta®/Revolade® (eltrombopag). (Source: GSK news)
Source: GSK news - February 3, 2014 Category: Pharmaceuticals Source Type: news
GSK announces headline results for Phase III study of the combination of Tafinlar® (dabrafenib) and Mekinist® (trametinib) in metastatic melanoma
GlaxoSmithKline plc [LSE/NYSE: GSK] today announced that a Phase III study of the combination of Tafinlar® (dabrafenib) and Mekinist® (trametinib), compared to single agent therapy with Tafinlar in patients with BRAF V600 E or K mutation positive unresectable or metastatic melanoma, met its primary endpoint of Progression Free Survival (PFS) (p<0.05) (Source: GSK news)
Source: GSK news - January 24, 2014 Category: Pharmaceuticals Source Type: news
GSK receives positive opinion from the CHMP in Europe for once-weekly EperzanTM (albiglutide) for the treatment of type 2 diabetes
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 albiglutide, under the brand name EperzanTM. (Source: GSK news)
Source: GSK news - January 24, 2014 Category: Pharmaceuticals Source Type: news
ViiV Healthcare’s new HIV medicine TivicayTM (dolutegravir) is approved in Europe
ViiV Healthcare today announced that the European Commission has approved TivicayTM (dolutegravir). (Source: GSK news)
Source: GSK news - January 21, 2014 Category: Pharmaceuticals Source Type: news
Tafinlar® receives FDA Breakthrough Therapy designation for non-small cell lung cancer with BRAF mutation
GlaxoSmithKline plc announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for Tafinlar® (dabrafenib). (Source: GSK news)
Source: GSK news - January 13, 2014 Category: Pharmaceuticals Source Type: news
Prosensa regains rights to drisapersen from GSK and retains rights to all other programmes for the treatment of Duchenne muscular dystrophy (DMD)
Prosensa Holding N.V. (NASDAQ: RNA) and GlaxoSmithKline (GSK) today announced that Prosensa has regained all rights from GSK to drisapersen. (Source: GSK news)
Source: GSK news - January 13, 2014 Category: Pharmaceuticals Source Type: news
GSK gains accelerated FDA approval for combination use of Mekinist® (trametinib) and Tafinlar® (dabrafenib)
GlaxoSmithKline plc [LSE/NYSE: GSK ] announced today that the U.S. Food and Drug Administration (FDA) has approved Mekinist® (trametinib) for use in combination with Tafinlar® (dabrafenib) for the treatment of patients with unresectable melanoma (melanoma that cannot be removed by surgery) or metastatic melanoma (melanoma which has spread to other parts of the body) with BRAF V600E or V600K mutations. (Source: GSK news)
Source: GSK news - January 9, 2014 Category: Pharmaceuticals Source Type: news
GSK adds detailed clinical trial data to multi-sponsor request system as part of continued commitment to data transparency
GlaxoSmithKline (GSK) has added its anonymised patient-level data from the online request system it launched in May 2013 to a new multi-sponsor request system. (Source: GSK news)
Source: GSK news - January 2, 2014 Category: Pharmaceuticals Source Type: news
GSK completes divestment of Lucozade and Ribena to Suntory
GlaxoSmithKline (“GSK”) today completed the previously announced divestment of its nutritional drinks brands Lucozade and Ribena to Suntory Beverage & Food Ltd for £1.35 billion. (Source: GSK news)
Source: GSK news - December 31, 2013 Category: Pharmaceuticals Source Type: news
