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News Breaks
July 3, 2014
09:42 EDTGNMSF, GSKGlaxoSmithKline, Genmab receive E.U. authorization for Arzerra
GlaxoSmithKline (GSK) and Genmab (GNMSF) announced that the European Commission has granted marketing authorization for a new indication for the use of Arzerra, or ofatumumab. The EC authorization of the first-line indication for Arzerra (ofatumumab) is based on results from two trials. One trial was a randomized, Phase III open-label, parallel-arm, multicenter, pivotal study evaluating the combination of ofatumumab and chlorambucil, versus chlorambucil alone in CLL patients for whom fludarabine-based treatment is considered inappropriate. In this study, treatment with ofatumumab and chlorambucil demonstrated a statistically significant, 71% improvement in median progression-free survival compared to chlorambucil alone. The second trial was a single-arm, multicenter, Phase II study evaluating ofatumumab in combination with bendamustine in 44 patients with previously untreated CLL for whom fludarabine-based treatment was considered inappropriate. Results of this study demonstrated that ofatumumab in combination with bendamustine provided an overall response rate of 95% and a complete response rate of 43%. Ofatumumab is also authorized in the EU for the treatment of patients with CLL refractory to fludarabine and alemtuzumab.
News For GSK;GNMSF From The Last 14 Days
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August 4, 2015
07:53 EDTGSKEndocyte names Alison Armour chief medical officer
Endocyte (ECYT) announced that Alison A. Armour has been appointed as chief medical officer. Prior to joining Endocyte, Dr. Armour served as vice president of oncology at Novartis (NVS) and GSK (GSK).
July 29, 2015
14:49 EDTGSKGlaxoSmithKline probing new bribery allegations in Romania, Reuters reports
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08:00 EDTGSKGlaxoSmithKline reports Q2 global pharmaceuticals revenue GBP2.98B, down 12%
Reports Q2 HIV revenue GBP559M, up 59%. Reports Q2 Pharmaceuticals revenue GBP3.54B, down 6%, and vaccines revenue GBP814M, up 11%. Consumer healthcare sales were GBP1.51B, up 51% year over year.
07:58 EDTGSKGlaxoSmithKline sees FY16 core EPS to grow in double digits
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07:57 EDTGSKGlaxoSmithKline reaffirms FY15 core EPS declining at high-teens percentage rate
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07:54 EDTGSKGlaxoSmithKline reports Q2 adjusted EPS 17.3p, consensus 16.78p
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July 27, 2015
17:31 EDTGSKRadius Health hires Dr. Lorraine Fitzpatrick as Chief Medical Officer
Radius Health (RDUS) announced that it has hired Dr. Lorraine A. Fitzpatrick as Chief Medical Officer of the Company. Dr. Fitzpatrick was previously Medicine Development Leader of an international clinical development team for Denosumab at GlaxoSmithKline (GSK), responsible for clinical development, regulatory, manufacturing, commercial, operations, epidemiology, and global health outcomes. Previously, Dr. Fitzpatrick led the clinical development of novel agents to treat musculoskeletal diseases and women's health at GlaxoSmithKline. Before joining GlaxoSmithKline, Dr. Fitzpatrick was Executive Director at Amgen, Inc. where she worked in the fields of osteoporosis and oncology.
08:03 EDTGSKNephroGenex names Jaikrishna Patel as Chief Medical Officer
NephroGenex (NRX) announced the appointment of Dr. Jaikrishna Patel to the position of Chief Medical Officer. Dr. Patel will help guide the company’s Phase 3 PIONEER program with oral Pyridorin for the treatment of diabetic nephropathy, and the development of an intravenous formulation of Pyridorin for acute kidney injury. Patel has held numerous positions of increasing responsibility at GlaxoSmithKline (GSK) and its predecessor companies, most recently serving as Vice President of Cardiovascular and Cardiovascular Metabolism, Global Regulatory Affairs.
July 24, 2015
05:04 EDTGSKAgenus reports GSK Malaria vaccine receives positive opinion from CHMP of EMA
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