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News Breaks February 7, 2013 10:33 EDT GSK GlaxoSmithKline 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 Check below for free stories on GSK the last two weeks. Sign up for a free trial to see the rest of the stories you've been missing. May 22, 2013 08:25 EDT GSK GlaxoSmithKline awarded up to $200M by U.S. to develop new antibiotics Subscribe for More Information May 21, 2013 07:44 EDT GSK Sachs Associates to host a forum Subscribe for More Information 07:07 EDT GSK Theravance pullback on Elan bid a buying opportunity, says Piper Jaffray Subscribe for More Information May 14, 2013 07:24 EDT GSK EBD Group to host a conference BioTrinity 2013 is being held in Newbury, England on May 14-16. May 13, 2013 16:25 EDT GSK On The Fly: Closing Wrap Stocks on Wall Street were little changed from their opening levels as investors weighed the potential end of the Fed's quantitative easing program against a better than expected report on retail sales. The Wall Street Journal's Jon Hilsenrath suggested in a report over the weekend that the Federal Reserve has mapped a QE exit strategy. The report paired with the retail sales data left the market lacking conviction in either direction today, as the averages spent the majority of the session range-bound near the flatline. ECONOMIC EVENTS: In the U.S., retail sales rose 0.1% in April, which beat expectations for a 0.3% decline. Retail sales excluding autos, gas, and building materials rose 0.6%, which was also better than expected. Business inventories were flat in March, versus expectations for a 0.3% gain. In Asia, Chinese factory output grew 9.3% annually in April, which was up from 8.9% in March but still missed expectations for a 9.5% growth rate. COMPANY NEWS: The Supreme Court ruled unanimously that Monsanto's (MON) patented genetically altered soybeans are protected and that farmers cannot use them to create new seeds without paying the company... Dell's (DELL) special committee publicly asked for more information from Carl Icahn and Southeastern Asset Management about their proposed leveraged recapitalization. This request follows television interviews by Icahn last Friday in which he discussed his Dell proposal, as well as a weekend report in Barron's saying the Icahn and Southeastern plan could be a better deal for shareholders. MAJOR MOVERS: Among the notable gainers was Theravance (THRX), up $6.26, or 17.92%, to $41.20 after Elan Corporation (ELN) bought a stake in the potential future royalty payments from four respiratory programs partnered with GlaxoSmithKline (GSK) in exchange for $1B in cash. Also higher was Tesla (TSLA), which rose $11.04, or 14.38%, to $87.80 in its third straight double-digit percentage gain following a better-than-expected earnings report last week. Among the noteworthy losers was Barnes & Noble (BKS), down $2.21, or 9.48%, to $21.10 after the blog InsiderMonkey disputed a previous report about Microsoft's (MSFT) interest in the bookseller's NOOK assets. Also lower was JoS. A. Bank (JOSB), down $3.31, or 7.16%, to $42.90 after the company's first quarter earnings view came in below expectations. INDICES: The Dow was down 26.81, or 0.18%, to 15,091.68; the Nasdaq was up 2.21, or 0.06%, to 3,438.79; and the S&P 500 was nearly unchanged at 1,633.77. 12:20 EDT GSK On The Fly: Midday Wrap Subscribe for More Information 05:44 EDT GSK Elan provides additional information on Elan/Theravance agreement Subscribe for More Information 05:35 EDT GSK Theravance, Elan enter into $1B royalty participation agreement Subscribe for More Information May 10, 2013 12:42 EDT GSK GlaxoSmithKline, Theravance confirm FDA approval of Breo Ellipta Subscribe for More Information 11:48 EDT GSK Drugmakers to face pressure on U.S. prices, Reuters says Subscribe for More Information 11:15 EDT GSK FDA approves Breo Ellipta to treat chronic obstructive pulmonary disease Subscribe for More Information 06:53 EDT GSK GlaxoSmithKline, Merck to discount cancer vaccine in poor nations, NY Times says Subscribe for More Information Sign up for a free trial to see the rest of the stories you've been missing.