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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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November 27, 2015
08:00 EDTGSKGlaxo has cut 40% of China sales reps in wake of scandal, Reuters reports
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07:34 EDTGSKGlaxoSmithKline starts phase III study of sirukumab in Giant Cell Arteritis
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November 25, 2015
11:29 EDTGSKStudy says Valeant, others exploding dermatology drug prices, WSJ reports
The JAMA Dermatology journal published a new study that found that retail prices of 19 dermatologic prescription drugs increased fivefold on average between 2009 and 2015, reported The Wall Street Journal. Targretin, marketed by Valeant (VRX), jumped to $30,320 this year from $15,708 last year and $1,687 in 2009, the study found, but "It's not just Valeant," said lead author Miranda Rosenberg. Prices for drugs made by GlaxoSmithKline (GSK) and Novartis (NVS) at least doubled or tripled over the same time frame, the report noted. Reference Link
November 24, 2015
11:16 EDTGSKAdaptimmune initiates Phase I/II trial of affinity enhanced T-cell therapy
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November 23, 2015
08:08 EDTGSKIdera Pharmaceuticals announces partnership with GSK
Idera Pharmaceuticals (IDRA) announced it has entered into an exclusive worldwide collaboration and license agreement with GSK (GSK) to research, develop and commercialize selected molecules from Idera's 3rd generation antisense platform for the treatment of selected targets in renal disease. Under the terms of the agreement, Idera is eligible to receive approximately $100M in development and regulatory milestone payments, including a $2.5M upfront payment. Additionally, Idera is eligible to receive royalties on all sales upon commercialization at varying rates up to five percent on annual net sales in excess of $500M.
November 18, 2015
08:11 EDTGSKIMS Health forecasts global drug spending to increase 30% by 2020 to $1.4T
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