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June 3, 2014
09:02 EDTBAXBaxter presents efficacy and safety data on VIVIA system at ERA-EDTA Congress
Baxter International announced the presentation of clinical data supporting the safety and efficacy of the VIVIA haemodialysis system. Results from two studies conducted in a clinical setting showed acceptable clearance of uremic toxins and an overall safety profile similar to that associated with conventional HD devices. The VIVIA system, designed to deliver High Dose HD in the home, completed the CE marking process in Europe, December 2013. The first in-human study was a prospective, single arm clinical study (Abstract #SP415) conducted in haemodialysis centres in the United States, in which 22 patients received four HD treatments with the VIVIA HD system every week for 10 weeks. The mean duration of each HD treatment was 3.8 hours. A mean weekly standard measure of urea clearance and dialysis adequacy, was 2.97. No device-related serious adverse events occurred during the study. The feasibility of multiple use of the same dialyser on the same patient was also established.
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March 25, 2015
07:12 EDTBAXAmerican Academy of Orthopedic Surgeons to hold annual meeting
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March 16, 2015
09:15 EDTBAXCTI BioPharma shares should be bought on weakness, says Roth Capital
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March 13, 2015
09:02 EDTBAXBaxter announces phase III trial of BAX 817 met primary endpoint
Baxter International announced positive results from its Phase III clinical trial evaluating the safety and efficacy of BAX 817, an investigational recombinant factor VIIa treatment for people with hemophilia A or B who develop inhibitors. The prospective, open-label, randomized, multicenter trial was designed to assess the safety and efficacy of BAX 817 in male patients ages 12 to 65 with hemophilia A or B with inhibitors over a 6-month period using on-demand therapy. The trial met its primary endpoint of successful resolution of acute bleeding episodes at 12 hours with both on-demand treatment regimens, dosing either 3x90 g/kg or 1x270 g/kg, with an overall success rate of 92% -- 98% and 85% in each dosing group, respectively. Further, 89% of patients in the trial achieved sustained bleeding control for all acute bleeding episodes 24 hours after infusion. No patients developed inhibitors or binding antibodies to BAX 817, and none discontinued treatment due to an adverse event. One patient was hospitalized following a traumatic muscle bleed that did not respond to BAX 817. Non-serious AEs observed in the trial were generally consistent with the underlying disease or other etiology, and were all deemed to be unrelated to treatment. Full data from the trial, including additional efficacy and safety outcomes, will be presented at a medical meeting later in 2015. The company plans to initiate regulatory submissions aligned to manufacturing expansions currently underway.

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