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News Breaks
December 14, 2012
17:44 EDTGSKGSK receives FDA approval for raxibacumab anti-toxin
GlaxoSmithKline announced that the U.S. FDA has approved raxibacumab for the treatment of adult and pediatric patients with inhalational anthrax due to Bacillus anthracis in combination with appropriate antibacterial drugs and for prophylaxis of inhalational anthrax when alternative therapies are not available or are not appropriate. Raxibacumab is the first monoclonal anti-toxin to be approved for inhalational anthrax. Raxibacumab is not approved or licensed in Europe and currently is not approved in other parts of the world for the treatment or prophylaxis of patients with inhalational anthrax. Raxibacumab was discovered and developed by Human Genome Sciences in conjunction with the Biomedical Advanced Research and Development Authority of the Office of the Assistant Secretary for Preparedness and Response, U.S. Department of Health and Human Services.
News For GSK From The Last 14 Days
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October 23, 2014
05:27 EDTGSKGlaxoSmithKline upgraded to Overweight from Equal Weight at Barclays
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October 22, 2014
14:43 EDTGSKTheravance drops after partner announces restructuring, posts abstracts
Shares of Theravance, (THRX) a biopharmaceutical company that has economic ties to GlaxoSmithKline (GSK), are lower in afternoon trading after Glaxo reported restructuring plans. Additionally, Theravance disclosed last night that GSK is scheduled to present data from Phase 3 studies at an upcoming medical conference. CHEST 2014 in Austin, Texas, to be held from October 25-30. WHAT'S NEW: Earlier today, GlaxoSmithKline announced it intends to refocus its global pharmaceuticals business and cost base following the divestment of its oncology products and the changed dynamics now faced in the U.S. respiratory market. Theravance has strategic alliances with GlaxoSmithKline in respiratory products. Also, Theravance disclosed last night that Glaxo is scheduled to present data from Phase 3 studies at CHEST 2014, which is being held from October 25-30. Umeclidinium/Vilanterol, a once-daily combination treatment comprising two bronchodilators in Theravance's ELLIPTA inhaler, and Fluticasone Furoate/Vilanterol, a once-daily combination of a LABA and inhaled corticosteroid, have been developed under a collaboration pact between Glaxo and Theravance. Abstracts of the planned oral presentations can be found in the CHEST Journal, Theravance noted in its filing. PRICE ACTION: In afternoon trading, shares of Theravance fell 10.25% to $16.73.
09:21 EDTGSKOn The Fly: Pre-market Movers
UP AFTER EARNINGS: Dow Chemical (DOW), up 3.7%... iRobot (IRBT), up 12%... Six Flags (SIX), up 13%... GlaxoSmithKline (GSK), up 2%... Broadcom (BRCM), up 7%... Boston Scientific (BSX), up 4.3%... Abbott (ABT), up 1.8%... Yahoo! (YHOO), up 6%. ALSO HIGHER: Blue Earth (BBLU), up 26.4% after CEO says statements in Seeking Alpha blog are "false and misleading."... GW Pharmaceuticals (GWPH), up 5.4% after Epidiolex receives orphan designation from EMA. DOWN AFTER EARNINGS: 3D Systems (DDD), down 15%... Biogen (BIIB), down 7%... Lumber Liquidators (LL), down 13.4%... Norfolk Southern (NSC), down 3%... Angie's List (ANGI), down 8.8%. ALSO LOWER: Nanosphere (NSPH), down 33% after filing secondary, reporting preliminary Q3 revenue... Himax Technologies (HIMX), down 16% after announcing that Google (GOOG) will not exercise an additional investment option in the company... Cree (CREE), down 10.5%, downgraded at DA Davidson and Canaccord following the company's Q1 earnings results... Ocwen Financial (OCN), down 7% after downgraded to Hold at Evercore, downgraded to Neutral at BofA Merrill Lynch... VMware (VMW), down 7.8%, downgraded at Nomura and Raymond James following the company's Q3 results.
07:49 EDTGSKGlaxoSmithKline sees FY14 dividend to rise 3% to 80p, 2015 dividend flat
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07:48 EDTGSKGlaxoSmithKline announces restructuring program for pharmaceuticals business
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07:46 EDTGSKGlaxoSmithKline to explore IPO of minority shareholding in ViiV Healthcare
Glaxo announced "further significant steps" within its Pharmaceuticals business to realize value for shareholders and deliver improved operational performance. Glaxo stated: "Five years ago, we created ViiV Healthcare, a new standalone global business focused on development of treatments for HIV. This has been a highly innovative and successful venture with our equity partners Pfizer and Shionogi. The business has made very significant progress in both R&D and commercial execution, culminating in the recent successful launches of Tivicay and Triumeq. We believe now is the right time to explore the potential for an IPO of a minority shareholding in this business. This will provide greater visibility of the intrinsic value we see in its currently marketed assets and future pipeline and also enhance potential future strategic flexibility."
07:44 EDTGSKGlaxoSmithKline backs FY14 view for core EPS 'broadly similar' to FY13
GlaxoSmithKline (GSK) continues to expect full year 2014 core EPS to be broadly similar to 2013 at CER and on ex-divestment basis. Glaxo says its proposed 3-part transaction with Novartis (NVS) is on track for completion in 1H15.
07:42 EDTGSKGlaxoSmithKline reports Q3 core EPS 27.9p, up 5% CER ex-divestments
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06:41 EDTGSKWHO fast-tracking testing of two Ebola vaccines, Guardian reports
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October 21, 2014
11:04 EDTGSKGlaxoSmithKline receives orphan status for dabrafenib
The FDA granted GlaxoSmithKline orphan status for dabrafenib, its possible treatment of patients with BRAF mutation positive non-small cell lung cancer.
07:06 EDTGSKFierce Biotech to hold a breakfast meeting
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October 20, 2014
09:09 EDTGSKEMA encourages applications for orphan designation for Ebola treatments
The European Medicines Agency encourages developers of treatments or vaccines against Ebola to apply for orphan designation. Applications for orphan designation of Ebola medicines will be treated as a priority and EMA has committed to fast-tracking their evaluation, the regulator announced. Drug companies that are working on experimental Ebola vaccines and treatments include Tekmira (TKMR), Sarepta (SRPT), BioCryst (BCRX), Chimerix (CMRX), NewLink Genetics (NLNK) and GlaxoSmithKline (GSK).
07:19 EDTGSKIBC Life Sciences to hold a conference
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October 17, 2014
14:50 EDTGSKBARDA asks labs to ramp up Zmapp production, Reuters says
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11:17 EDTGSKGSK says Ebola vaccine too late for current epidemic, BBC reports
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October 14, 2014
13:09 EDTGSKGlaxoSmithKline seeks binding bids for mature drugs, Reuters reports
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11:23 EDTGSKBIND Therapeutics and The Conference Forum hold a conference
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11:19 EDTGSKNIH says several potential Ebola treatments under development
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10:10 EDTGSKNIH director says supporting BioCryst, Chimerix Ebola treatments
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October 13, 2014
07:12 EDTGSKOligonucleotide Therapeutics Society to hold annual meeting
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