News Breaks |
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| December 14, 2012 |
| 17:44 EDT |  | GSK | GSK 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. |
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News For GSK From The Last 14 Days Check below for free stories on GSK the last two weeks. |
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| June 18, 2013 |
| 08:37 EDT |  | GSK | Drug companies turn to microchips to test medicines, WSJ reports
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| 07:13 EDT | | GSK | Aspen in talks buy GSK's Arixtra, Fraxiparine brands
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| 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. |
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| June 12, 2013 |
| 19:54 EDT | | GSK | GlaxoSmithKline investigates bribe claims in China, WSJ says
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| 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 |
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| June 6, 2013 |
| 15:59 EDT | | GSK | FDA votes for modified restrictions on GSK's Avandia, Reuters says
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| 15:42 EDT | | GSK | FDA panel revote reaffirms modified restrictions for GSK's Avandia, Reuters says
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| 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. |
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| 15:20 EDT | | GSK | FDA panel votes to modify market restrictions for Avandia, Reuters says
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| 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. Webcast Link |
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