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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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April 24, 2015
07:11 EDTGSKAgenus: GSK's RTS,S vaccine showed statistically significant results in study
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April 20, 2015
07:20 EDTGSKAmerican Association for Cancer Research to hold annual meeting
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07:01 EDTGSKPernix Therapeutics obtains six months U.S. pediatric exclusivity for Treximet
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April 16, 2015
09:48 EDTGNMSFGenmab achieves $10M milestone in daratumumab collaboration with Janssen
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09:14 EDTGSKAdamis says albuterol HFA product study met clinical FEV1 primary endpoint
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08:15 EDTGSKGlaxoSmithKline and Theravance announce launch of Anoro in Spain
In a regulatory filing, GlaxoSmithKline (GSK) and Theravance (THRX) announced the launch of Anoro in Spain following the approval in Europe in May 2014. Anoro Ellipta is indicated as a once-daily maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease. Anoro Ellipta is a combination of two bronchodilators, umeclidinium, a long-acting muscarinic antagonist and vilanterol, a long-acting beta2 agonist, in a single dry powder inhaler, the Ellipta. The approved dose of UMEC/VI is 55/22mcg. UMEC/VI has been developed under the 2002 LABA collaboration agreement between Glaxo Group Limited and Theravance.
April 15, 2015
11:53 EDTGSKGlaxoSmithKline initiated with a Sell at Societe Generale

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