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News Breaks
April 23, 2014
09:02 EDTBAXBaxter announces FDA approval of Advate with Baxject III reconstitution system
Baxter International announced that the U.S. Food and Drug Administration has approved a new reconstitution system for ADVATE. ADVATE and the diluent come pre-packaged in the new BAXJECT III reconstitution system.
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May 21, 2015
09:05 EDTBAXBaxter files for European approval of investigational IGSC 20% treatment for PI
Baxter International announced that its BioScience business has submitted a marketing authorization application to 17 competent authorities in Europe following the decentralized procedure for approval of its investigational 20% concentration subcutaneous immune globulin, or IGSC, treatment for primary immunodeficiencies, or PI, a group of disorders in which part of the body's immune system is missing or does not function properly. Results from a separate study of IGSC 20% among patients with PI in North America are expected to be available in the coming months; based on the outcome of this study, Baxter intends to file for U.S. approval of the treatment before the end of 2015.
06:38 EDTBAXNovo Nordisk rejects claims made by Baxter, Reuters says
Novo Nordisk (NVO) rejects claims made by Baxter (BAX) that the company used substances made by Baxter in its Novoeight haemophilia treatment, following Monday's ITC investigation announcement, reports Reuters, citing an email from Novo Nordisk. Reference Link
May 18, 2015
12:24 EDTBAXBaxter sees FY16 sales growth 2%-3%
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12:20 EDTBAXBaxter sees 2H sales growth approximately flat in constant currency
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08:39 EDTBAXBaxter says Baxalta separation on-track for mid-year 2015
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May 15, 2015
17:31 EDTBAXBaxter gets FDA approval for Spain facility to produce Sodium Chloride Injection
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