GSK and Genmab receive FDA approval for Arzerra® (ofatumumab) as first-line treatment in combination with chlorambucil for patients with Chronic Lymphocytic Leukaemia (CLL) for whom fludarabine-based therapy is considered inappropriate
GlaxoSmithKline plc (LSE: GSK) and Genmab A/S (OMX: GEN) announced today that the U.S. Food and Drug Administration (FDA) has approved a Supplemental Biologic License Application (sBLA) for the use of Arzerra® (ofatumumab), a CD20-directed cytolytic monoclonal antibody, in combination with chlorambucil for the treatment of previously untreated patients with chronic lymphocytic leukaemia (CLL) for whom fludarabine-based therapy is considered inappropriate.
GlaxoSmithKline plc (LSE/NYSE: GSK) today announced that Incruse™ Ellipta™ (umeclidinium, as umeclidinium bromide) has received market authorisation in Canada for the long-term once-daily maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.
There has been recent publicity on cases of alleged misconduct by GSK employees in a number of countries. This is a result of details of these cases being made available to the media
GlaxoSmithKline plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has approved TanzeumTM (albiglutide) for injection, for subcutaneous use, as a once-weekly treatment for type 2 diabetes.
GSK issued the following statement in response to claims by BBC Panorama related to GSK in Poland, to be broadcast on Monday April 14 2014
Update on phase III clinical trial of investigational MAGE-A3 antigen-specific cancer immunotherapeutic in non-small cell lung cancer
GSK announced its decision to stop the MAGRITi trial, a Phase III trial of its MAGE-A3ii cancer immunotherapeuticiii in non-small cell lung cancer (NSCLC) patients, after establishing that it will not be possible to identify a sub-population of gene-signature positive NSCLC patients that may benefit from the treatment.
ViiV Healthcare announces new initiatives to improve access to dolutegravir: licence to the Medicines Patent Pool
ViiV Healthcare today announced new collaborations with the goal of increasing access to its HIV medicine, dolutegravir (marketed under the name Tivicay®), just two months after its approval by the European Medicines Agency (EMA) and eight months after approval by the US Food and Drug Administration (FDA).
Results from phase III patient preference study of GSK’s Votrient® (pazopanib) vs. Sutent® (sunitinib) in advanced renal cell carcinoma published in Journal of Clinical Oncology
Data from the first patient preference study in advanced renal cell carcinoma have been published in the Journal of Clinical Oncologyi.
Regulatory update: Votrient® (pazopanib) as maintenance therapy for advanced ovarian cancer in the EU
GlaxoSmithKline plc (LSE/NYSE: GSK) today announced that it has withdrawn its application to the European Medicines Agency (EMA) for a variation to the Marketing Authorisation for Votrient® (pazopanib).
GSK announces new strategic investments in Africa to increase access to medicines, build capacity and deliver sustainable growth
GSK today announced a series of new investments in sub-Saharan Africa designed to address pressing health needs and contribute to long-term business growth.