Press releases
GSK receives FDA Complete Response letter for Avodart for prostate cancer risk reduction supplemental indication
GlaxoSmithKline (GSK) today announced that the Company has received a Complete Response letter from the U.S. Food and Drug Administration (FDA) for the supplemental New Drug Application (sNDA) for Avodart® (dutasteride) for reducing the risk of prostate cancer in men at increased risk for the disease, defined as those who have had a prior negative biopsy due to clinical concern and have an elevated serum prostate-specific antigen (PSA).
GlaxoSmithKline announces start of two phase III studies in advanced/metastatic melanoma
GlaxoSmithKline (GSK) announced today the start of two global Phase III studies in advanced or metastatic melanoma patients with a BRAF V600 mutation. The studies will separately assess the efficacy and safety of two investigational agents, GSK2118436 and GSK1120212, to determine their individual ability to stop or slow the progression of skin cancer in patients whose tumours contain a BRAF V600 mutation, which occurs in 50 to 60 percent of melanoma patients.Commencement of these studies confirms previously announced plans to progress these assets into Phase III.
Regulatory update - GSK and Valeant receive positive opinion in Europe from the CHMP for Trobalt (retigabine)
GlaxoSmithKline (GSK) and Valeant Pharmaceuticals International, Inc. (NYSE & TSX: VRX) announced today that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion, recommending marketing authorisation for Trobalt™(retigabine) as an adjunctive (add-on) treatment of partial onset seizures (a form of epilepsy where a seizure begins in a specific area in one side of the brain), with or without secondary generalisation in adults aged 18 years and above with epilepsy.
GlaxoSmithKline commences Phase III study of intravenous zanamivir for hospitalised patients with influenza
GlaxoSmithKline (GSK) announced today that the first patient has received treatment in a pivotal Phase III study of hospitalised patients with influenza which compares intravenous (IV) zanamivir to oral oseltamivir. The primary endpoint of this study is time to clinical response in patients with confirmed influenza.
GSK and Prosensa announce start of Phase III study of investigational Duchenne Muscular Dystrophy medication
GlaxoSmithKline (GSK) and Prosensa today announced that the first patient has commenced treatment in the Phase III clinical study investigating GSK2402968 (`968), in ambulant boys with Duchenne Muscular Dystrophy (DMD), who have a dystrophin gene mutation amenable to an exon 51 skip (up to 13% of boys with DMD). Commencement of this study confirms previously announced plans to progress this asset into Phase III.
GlaxoSmithKline announces Q4 2010 legal charge
GlaxoSmithKline (GSK) today announces that it expects to record a legal charge for the fourth quarter of 2010 of £2.2 billion ($3.4 billion) (equating to an after tax cost of £1.8 billion).
GlaxoSmithKline and ChemoCentryx announce initiation of Phase III study of GSK’786, formerly Traficet-EN™, for the treatment of Crohn’s disease
GlaxoSmithKline (GSK) and ChemoCentryx, Inc. announced today that the first patient with Crohn’s disease has initiated treatment in the initial pivotal induction study comparing Traficet-EN, now designated GSK1605786 (‘786), to placebo. This marks the start of the Phase III clinical development programme for ‘786 for the treatment of this serious and chronic disease.
GlaxoSmithKline and DENTSPLY International sign global agreement to create a portfolio of co-branded professional oral care products
GlaxoSmithKline (GSK) and DENTSPLY International, a global leader in professional dental products, today announced that they have entered into an agreement to create a portfolio of co-branded oral care products to be used in the dental office by patients suffering from tooth sensitivity, a problem which is estimated to affect 1 in 3 people.
GSK responds to 60 Minutes
GlaxoSmithKline [GSK] issued the following response regarding a 60 Minutes program on January 2 that focused on a manufacturing facility in Puerto Rico which was formerly owned by the company
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