FDA grants GSK and Genmab’s Arzerra® (ofatumumab) Breakthrough Therapy designation for previously untreated chronic lymphocytic leukaemia
GlaxoSmithKline plc (LSE:GSK) and Genmab A/S (OMX: GEN) announced today that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for Arzerra® (ofatumumab) in combination with chlorambucil for the treatment of patients with chronic lymphocytic leukaemia (CLL) who have not received prior treatment and are inappropriate for fludarabine-based therapy. (Source: GSK news)
Source: GSK news - September 13, 2013 Category: Pharmaceuticals Source Type: news
GSK statement in response to patent ruling reversal on Lovaza
GlaxoSmithKline confirmed today that the Court of Appeals for the Federal Circuit has ruled against Pronova Biopharma Norge AS in its patent litigation regarding Lovaza® (omega-3-acid ethyl esters). (Source: GSK news)
Source: GSK news - September 13, 2013 Category: Pharmaceuticals Source Type: news
ViiV Healthcare Presents Positive Data from Phase IIIb/IV Study of Dolutegravir vs Darunavir in Treatment-Naïve Adults with HIV-1
ViiV Healthcare today announced initial results from the Phase IIIb/IV FLAMINGO (ING114915) study. (Source: GSK news)
Source: GSK news - September 12, 2013 Category: Pharmaceuticals Source Type: news
FDA Advisory Committee recommends approval in US of umeclidinium/vilanterol for the treatment of COPD
GlaxoSmithKline plc (LSE: GSK) and Theravance, Inc. (NASDAQ: THRX) today announced that the Pulmonary-Allergy Drugs Advisory Committee (PADAC) to the US Food and Drug Administration (FDA) voted 11 yes to 2 no that the efficacy and safety data provide substantial evidence to support approval of umeclidinium/vilanterol (UMEC/VI, 62.5/25mcg dose) 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. (Source: GSK news)
Source: GSK news - September 10, 2013 Category: Pharmaceuticals Source Type: news
GSK reaches agreement to divest Lucozade and Ribena for £1.35 billion
GlaxoSmithKline (LSE:GSK) today announced it has reached agreement to sell its nutritional drinks brands Lucozade and Ribena to Suntory Beverage & Food Ltd. (Source: GSK news)
Source: GSK news - September 9, 2013 Category: Pharmaceuticals Source Type: news
The investigational MAGE-A3 antigen-specific cancer immunotherapeutic does not meet first co-primary endpoint in Phase III melanoma clinical trial
In line with the Independent Data Monitoring Committee’s (IDMC) unanimous recommendation, GSK will continue the DERMA trial until the second co-primary endpoint is assessed. (Source: GSK news)
Source: GSK news - September 5, 2013 Category: Pharmaceuticals Source Type: news
GSK receives marketing authorisation from the European Commission for Tafinlar™ (dabrafenib), an oral treatment for unresectable or metastatic melanoma in adult patients with a BRAF V600 mutation
GlaxoSmithKline plc announced today that the European Commission has granted marketing authorisation for Tafinlar™ (dabrafenib). (Source: GSK news)
Source: GSK news - September 2, 2013 Category: Pharmaceuticals Source Type: news
GSK announces phase III study of vercirnon in patients with moderate-to-severe Crohn’s disease did not meet its primary endpoint
GSK announced that the first of four Phase III studies, the SHIELD-1 study, investigating vercirnon - an investigational CCR9 antagonist - in adult patients with moderately-to-severely active Crohn’s disease did not achieve the primary endpoint of improvement in clinical response and the key secondary endpoint of clinical remission. (Source: GSK news)
Source: GSK news - August 23, 2013 Category: Pharmaceuticals Source Type: news
GSK receives marketing authorisation from the European Commission for additional indication: Tyverb™ (lapatinib) in combination with trastuzumab for patients with HER2-positive, HR-negative metastatic breast cancer
GlaxoSmithKline announced today that the European Commission has granted an additional indication for Tyverb™ (lapatinib) to be used in combination with trastuzumab. (Source: GSK news)
Source: GSK news - August 14, 2013 Category: Pharmaceuticals Source Type: news
ViiV Healthcare announces U.S. approval of Tivicay® (dolutegravir) for the treatment of HIV-1
ViiV Healthcare is pleased to announce today that the U.S. Food and Drug Administration (FDA) has approved Tivicay® (dolutegravir) 50-mg tablets. (Source: GSK news)
Source: GSK news - August 12, 2013 Category: Pharmaceuticals Source Type: news
GSK launches $50 million venture capital fund to invest in pioneering bioelectronic medicines and technologies
'Action Potential Venture Capital' makes first investment in SetPoint Medical, developer of implantable device for treating inflammatory diseases. (Source: GSK news)
Source: GSK news - August 8, 2013 Category: Pharmaceuticals Source Type: news
Regulatory update – GSK announces EU submission for Cervarix® two dose schedule
GlaxoSmithKline (GSK) plc today announced the submission of a regulatory application in the European Union for a two dosing schedule in 9-14 year old girls for its cervical cancer vaccine. (Source: GSK news)
Source: GSK news - August 7, 2013 Category: Pharmaceuticals Source Type: news
Regulatory Update - GSK announces EU submission seeking additional indication for Votrient® as maintenance therapy for advanced ovarian cancer
GlaxoSmithKline (GSK) plc today announced submission to the European Medicines Agency of a variation to the Marketing Authorisation for Votrient® (pazopanib) (Source: GSK news)
Source: GSK news - August 7, 2013 Category: Pharmaceuticals Source Type: news
Regulatory update: albiglutide US PDUFA date extended by three months
GlaxoSmithKline plc (LSE:GSK) today announced that the US Prescription Drug User Fee Act (PDUFA) goal date for albiglutide, an investigational once-weekly treatment for adult patients with type 2 diabetes, has been extended by three months. (Source: GSK news)
Source: GSK news - August 2, 2013 Category: Pharmaceuticals Source Type: news
GSK adds to its commitment to GAVI Alliance to help protect millions more children against infectious diseases
New extension of Synflorix vaccine supply agreement will help protect an additional 80 million children in the world’s poorest countries from pneumococcal disease. (Source: GSK news)
Source: GSK news - July 29, 2013 Category: Pharmaceuticals Source Type: news
