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News Breaks December 18, 2012 07:20 EDT GSK, THRX GlaxoSmithKline, Theravance announce U.S. regulatory submission for UMEC/VI GlaxoSmithKline (GSK) and Theravance (THRX) announced the submission of a regulatory application in the US for the investigational once-daily LAMA/LABA combination medicine, UMEC/VI, for patients with chronic obstructive pulmonary disease, or COPD. UMEC/VI is a combination of two investigational bronchodilator molecules -- GSK573719 or umeclidinium bromide, or UMEC, a long-acting muscarinic antagonist, or LAMA, and vilanterol, a long-acting beta2 agonist, or LABA, administered using the ELLIPTA inhaler. US Submission: A New Drug Application, or NDA, for UMEC/VI with the proposed proprietary name Anoro Ellipta has been submitted to the FDA, for the long-term once-daily maintenance bronchodilator treatment of airflow obstruction in patients with COPD, including chronic bronchitis and emphysema. 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. June 18, 2013 08:37 EDT GSK Drug companies turn to microchips to test medicines, WSJ reports Subscribe for More Information 07:13 EDT GSK Aspen in talks buy GSK's Arixtra, Fraxiparine brands Subscribe for More Information 07:07 EDT GSK GlaxoSmithKline receives offer for thrombosis brands from Aspen GlaxoSmithKline said it received an offer for its thrombosis brands and Notre-Dame de Bondeville site from Aspen Global. A period of exclusivity has been agreed with Aspen. The financial terms are confidential at this time, but the offer includes the transfer of the Arixtra and Fraxiparine brands to Aspen, along with the related manufacturing site and the majority of employees at NDB in France and certain dedicated commercial employees, GSK said. "The proposed transaction is aligned to GSK's strategy of focusing on products with the most growth potential and the delivery of its pipeline," the company added. June 17, 2013 08:23 EDT THRX Elan holders do not approve Theravance/Elan royalty participation transaction Subscribe for More Information June 14, 2013 05:35 EDT THRX Elan holders vote against Theravance, AOP transactions Royalty Pharma announces that holders of approximately 311M Elan (ELN) ADSs, representing more than 81% of the Elan ADSs held in street name, had voted on the Elan proposals through Broadridge. Based on a review of those votes, a sufficient number of these ADSs have been voted AGAINST both the Theravance (THRX) Transaction and the AOP Transaction such that Royalty Pharma is confident that those proposals will not pass at Elan's June 17 EGM. A narrow majority of these ADSs have been voted AGAINST the ELND005 Transaction. A narrow majority of these ADSs have been voted FOR the Share Repurchase Program but this majority can be overturned by a sufficient vote by ordinary shareholders. There can be no assurance that Elan will conduct a sale process, that any sale process that is conducted will be conducted fairly, or that any proposal to acquire Elan will be presented to Elan Shareholders. Even if Elan does conduct a sale process, given that Royalty Pharma's offer of $13 plus an up to $2.50 CVR has been deemed "grossly inadequate" by Elan, there can be no assurance that Elan will not conclude that all other offers they receive are "grossly inadequate". June 12, 2013 19:54 EDT GSK GlaxoSmithKline investigates bribe claims in China, WSJ says Subscribe for More Information 07:16 EDT GSK GlaxoSmithKline fires head of R&D in China, WSJ says GlaxoSmithKline has fired it's head of R&D in China after finding that he had incorporated "misinterpreted" data in a paper he helped write for a journal, Nature Medicine, according to The Wall Street Journal, citing the company. Reference Link June 10, 2013 05:35 EDT THRX Elan tells advisors to assess all strategic interests Subscribe for More Information June 7, 2013 06:41 EDT THRX Royalty Pharma raises offer for Elan to $13 per share plus CVR Royalty Pharma announced that it increased its offer for Elan to $13.00 in cash per share plus a contingent value right worth up to $2.50 per share. The consideration is not conditional on due diligence, Royalty added. Royalty Pharma said it will waive down the acceptance yhreshold to 50% plus one share if all other conditions to its increased offer are satisfied, fulfilled or, to the extent permitted, waived. Royalty Pharma noted that its offer will lapse if the Theravance (THRX) resolution or any of the other resolutions are approved by Elan stockholders. June 6, 2013 15:59 EDT GSK FDA votes for modified restrictions on GSK's Avandia, Reuters says Subscribe for More Information 15:42 EDT GSK FDA panel revote reaffirms modified restrictions for GSK's Avandia, Reuters says 15:26 EDT GSK FDA advisers say Glaxo Avandia vote may have been inaccurate, Bloomberg says Advisers plan to take a break to assess problem with vote tally and plan to re-vote on GSK's Avandia after break, Bloomberg says. 15:20 EDT GSK FDA panel votes to modify market restrictions for Avandia, Reuters says Subscribe for More Information June 5, 2013 07:45 EDT GSK FDA to host a joint committee meeting Joint Meeting of the Endocrinilogic & Metabolic Drugs Advisory Committee and the Drug Safety & Risk Management Advisory Committee where the discussion on both days will be on GlaxoSmithKline's New Drug Application (NDA) 21071 for AVANDIA (Rosiglitazone Maleate) tablets is being held in FDA Offices in Silver Spring, Maryland on June 5-6 beginning at 8 am. 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