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News Breaks | | | | December 19, 2012 | | 16:12 EDT |  | FOLD, GSK | Amicus Theraputics and GlaxoSmithKline report results from Phase 3 Fabry study
Amicus Therapeutics (FOLD) and GlaxoSmithKline (GSK) announced the 6-month primary treatment period results from the first Phase 3 global registration study of investigational oral migalastat HCl monotherapy in males and females with Fabry disease who had genetic mutations identified as amenable to migalastat HCl in a cell-based assay. The pre-designated primary endpoint was the number of patients who demonstrated a 50% or greater reduction in kidney interstitial capillary globotriaosylceramide-3 after 6 months of treatment with migalastat HCl compared to placebo. 13/32 (41%) in the migalastat HCl treatment group achieved the endpoint versus 9/32 (28%) in the placebo group. This difference did not achieve statistical significance. A pre-specified secondary analysis assessing the absolute percent change in kidney interstitial capillary GL-3 from baseline to month 6 showed a median reduction of 41% in the migalastat HCl group versus a median reduction of 6% in the placebo group. To date, no drug-related serious adverse events have been observed. | |
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News For FOLD;GSK From The Last 14 Days Check below for free stories on FOLD;GSK the last two weeks. |
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| 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 | | | May 9, 2013 | | 16:18 EDT |  | FOLD | Amicus Theraputics reports Q1 EPS (35c), consensus (33c)
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