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News Breaks
January 23, 2014
08:45 EDTBAXBaxter says recently received FDA warning letter on manufacturing
Baxter said it recently received an FDA warning letter primarily directed to its quality systems in Round Lake, Illinois for certain medical devices. Baxter says it is working with FDA on issues noted in the warning letter and that the company does not expect an impact on product availability based on the letter. The company also said, that while "it took longer than we expected" to complete the regulatory process, the company is "pleased" with the progress it is making on the integration of Gambro. Comments made during Q4 earnings conference call.
News For BAX From The Last 14 Days
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May 29, 2015
07:03 EDTBAXBaxter aays remote technology may improve patient access to home therapy
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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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