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News Breaks September 26, 2012 05:43 EDT GSK, THRX GSK and Theravance announce FDA acceptance of FF/VI NDA for COPD in U.S. GlaxoSmithKline (GSK) and Theravance (THRX) announced that the New Drug Application, or NDA, for the once-daily investigational medicine fluticasone furoate "FF"/vilanterol "VI", or FF/VI, for patients with chronic obstructive pulmonary disease, or COPD, has been accepted by the U.S. FDA indicating that the application is sufficiently complete to permit a substantive review. The Prescription Drug User Fee Act, or PDUFA, goal date has also been confirmed as May 12, 2013. GSK also submitted a Japanese New Drug Application, or JNDA, for FF/VI for patients with COPD and asthma on Sept. 25. News For GSK;THRX From The Last 14 Days Check below for free stories on GSK;THRX the last two weeks. Sign up for a free trial to see the rest of the stories you've been missing. May 16, 2013 11:27 EDT THRX Options with decreasing implied volatility: LNCO MBI OPK THRX SGMO Subscribe for More Information May 15, 2013 11:13 EDT THRX Options with decreasing implied volatility: MM GMCR GRPN THRX SGMO Subscribe for More Information May 14, 2013 12:16 EDT THRX Options with decreasing implied volatility: MM PANL DGIT VCLK THRX Subscribe for More Information 08:16 EDT THRX Theravance price target raised to $48 from $38 at RW Baird Subscribe for More Information 07:24 EDT GSK EBD Group to host a conference BioTrinity 2013 is being held in Newbury, England on May 14-16. 07:07 EDT THRX Theravance price target raised to $54 from $44 at Stifel Stifel thinks that Theravance's (THRX) royalty deal with Elan (ELN) demonstrates its ability to generate revenue that had not been reflected in its stock price. The firm expects Theravance to make similar deals in the future and it keeps a Buy rating on the stock. May 13, 2013 16:25 EDT THRX, 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 THRX, GSK On The Fly: Midday Wrap Subscribe for More Information 09:25 EDT THRX On The Fly: Pre-market Movers Subscribe for More Information 05:44 EDT GSK, THRX Elan provides additional information on Elan/Theravance agreement Subscribe for More Information 05:35 EDT GSK, THRX Theravance, Elan enter into $1B royalty participation agreement Subscribe for More Information 05:31 EDT THRX Theravance, Elan enter into $1B royalty participation agreement 05:26 EDT THRX Theravance to host conference call Subscribe for More Information May 10, 2013 12:42 EDT THRX, 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 11:17 EDT THRX Theravance jumps 12% to $35.12 following FDA approval for COPD drug Subscribe for More Information 11:15 EDT THRX, 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 May 9, 2013 06:12 EDT THRX Theravance price target raised to $44 from $32 at Piper Jaffray Subscribe for More Information May 6, 2013 07:49 EDT GSK Bernstein's global pharmaceuticals analyst has analyst/industry conference call Subscribe for More Information Sign up for a free trial to see the rest of the stories you've been missing.