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News Breaks
February 7, 2013
10:33 EDTGSKGlaxoSmithKline submits MEK monotherapy, BRAF/MEK combo therapy to EMA
GlaxoSmithKline announced submission of a Marketing Authorization Application to the European Medicines Agency for trametinib, or MEK, as monotherapy and in combination with dabrafenib, or BRAF, for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation. The EMA’s Committee for Medicinal Products for Human Use has granted GSK’s request for accelerated assessment of this application, the company said. An application that has been granted accelerated assessment will have a maximum review time of 150 days. However, at any time during the assessment CHMP may decide to continue the assessment under the standard centralised procedure assessment timelines of 210 days or GSK may submit a request for a change to a standard assessment procedure.
News For GSK From The Last 14 Days
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April 16, 2015
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
April 7, 2015
07:14 EDTGSKEyeforpharma to hold a summit
Philadelphia 2015 Commercial Pharma Summit is being held in Philadelphia on April 7-8.

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