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News Breaks | | | | October 12, 2012 | | 08:06 EDT |  | GSK, IPXL | Impax says FDA extends PDUFA date for Rytary review to January 21, 2013
Impax Pharmaceuticals, the branded products division of Impax Laboratories (IPXL), announced that the U.S. Food and Drug Administration has extended the Prescription Drug User Fee Act, or PDUFA date for its review of the Rytary New Drug Application from October 21, 2012, to January 21, 2013. The FDA notified Impax that its September 28 submission of requested information on an excipient in the Rytary formulation to the FDA has been designated as a major amendment. Since the receipt date of this additional information is within three months of the PDUFA date, the FDA has exercised its option to extend the PDUFA date to review the information. No new clinical trials or studies have been requested by the FDA. Rytary, an investigational extended release capsule formulation of carbidopa-levodopa for the treatment of idiopathic Parkinson’s disease, has been licensed to GlaxoSmithKline (GSK) for countries outside the U.S. and Taiwan for development and marketing, the company noted. | |
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News For IPXL;GSK From The Last 14 Days Check below for free stories on IPXL;GSK the last two weeks. |
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| May 22, 2013 | | 08:25 EDT | | GSK | GlaxoSmithKline awarded up to $200M by U.S. to develop new antibiotics
 Subscribe for More Information | | | 07:28 EDT |  | IPXL | UBS to host a conference
Global Healthcare Services Conference is being held in New York on May 20-22 with webcasted company presentations to begin on May 22 at 8 am; not all company presentations may be webcasted. Webcast Link | | | 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 17, 2013 | | 08:41 EDT | | IPXL | Impax commenced shipment of authorized generic Zomig
Impax (IPXL) announced that its generics division, Global Pharmaceuticals, commenced shipment of authorized generic Zomig tablets, as part of an agreement with AstraZeneca (AZN). Zomig is indicated for the treatment of migraine headaches in adults. According to IMS Health data, U.S. sales of Zomig tablets and orally disintegrating tablets were approximately $196M in the 12 months ended April 2013. | | | 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 | | | 07:49 EDT | | IPXL | FDA decision on Opana a modest positive for Impax, says Leerink
Leerink views the FDA's denial of Endo's (ENDP) Citizen Petition as a modest positive for Impax (IPXL), which it notes is the sole holder of 180 day exclusivity on generic Opana. However, Leerink says upside for Impax will be limited as Actavis (ACT), Sandoz, and Teva (TEVA) have settlements to enter the market starting in June 2013 when Impax's 180-day generic exclusivity expires. | | | 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
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