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August 21, 2014
09:02 EDTBAXBaxter announces BAX 855 met primary endpoint in Phase 3 study
Baxter announced "positive" results from its Phase 3 pivotal clinical trial of BAX 855, which met its primary endpoint in reducing annualized bleed rates in the prophylaxis arm compared to the on-demand arm. Top-line results from the prospective, global, multi-center Phase 3 study demonstrated that BAX 855 met its primary endpoint in the control and prevention of bleeding, routine prophylaxis and perioperative management for patients who were 12 years or older. Patients in a twice-weekly prophylaxis arm experienced a 95% reduction in median ABR as compared to those in the on-demand arm. BAX 855 was also effective in treating bleeding episodes, 96% of which were controlled with one or two infusions. The half-life of BAX 855 was 1.4 1.5 times that of ADVATE, consistent with the findings from the Phase 1 study. No patients developed inhibitors to BAX 855 and no treatment-related serious adverse events, including hypersensitivity, were reported. The most common product-related adverse event was headache. Baxter expects to submit a Biologics License Application for BAX 855 to the U.S. Food and Drug Administration before the end of 2014 and will present additional data in the coming months. In addition to an ongoing continuation study for patients who have completed the pivotal trial, the company is initiating a Phase 3, prospective, open-label, multi-center study to evaluate the safety and efficacy of BAX 855 among 60 previously treated patients under the age of 12 with severe hemophilia A. Consistent with guidelines published by the European Medicines Agency that require a study in children less than 12 years of age prior to filing, Baxter expects to file a Marketing Authorization Application with the EMA upon the completion of the pediatric study.
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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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May 13, 2015
10:40 EDTBAXBaxter to host two day investor meeting
Two day Investor meeting to be held in New York May 18-19.
May 12, 2015
09:02 EDTBAXBaxter expects to establish BioScience business as separate business by mid-year
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09:01 EDTBAXBaxter to acquire Oncaspar product portfolio from Sigma-Tau for $900M
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07:06 EDTBAXKamada sees FY15 revenue $70M-$73M, consensus $78.69M
Kamada (KMDA) sees revenue from its Distributed Product Segment projected to be between $26 million and $28 million and revenue from its Proprietary Products Segment projected to be between $45 million and $47 million. The company notes that revenue projections for 2015 take into account an expected negative foreign exchange impact of approximately $2.0 million in relation to product sales in Israel and Russia, and presume that U.S. revenue from the agreement with Baxter (BAX) remains on track.

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