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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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July 2, 2015
18:37 EDTGSKViiV, Desano enter strategic manufacturing agreement for Tivicay
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June 26, 2015
10:38 EDTGSKCourt revives lawsuit over GlaxoSmithKline Lamictal drug, Bloomberg reports
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June 25, 2015
14:01 EDTGSKGlaxoSmithKline initiated with a Buy at HSBC
Price target GBP 17.
June 24, 2015
13:37 EDTGSKGSK says CDC committee votedfor meningococcal group B vaccines
GlaxoSmithKline (GSK) announced that the U.S. Centers for Disease Control Advisory Committee on Immunization Practices voted for a Category B recommendation for meningococcal group B vaccination, including Bexsero, in individuals aged 16 to 23. Bexsero was approved by the FDA in January for use in individuals aged 10 through 25 years and acquired by GSK in March following the closure of the three-part transaction with Novartis (NVS).
June 23, 2015
07:25 EDTGSKPiper Jaffray to hold a summit
2015 Piper Jaffray Heartland Summit is being held in Minneapolis on June 23-24.

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