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January 3, 2014
16:36 EDTBAXBaxter announces recall of parenteral nutrition products
Baxter announced it has initiated a voluntary recall in the United States of two lots of Clinimix and one lot of Clinimix E Injection parenteral nutrition products to the user level due to complaints of particulate matter found in the products. If infused, particulate matter may result in blockages of blood vessels, which can result in stroke, heart attack, or damage to other organs such as the kidney or liver, the company said. There is also the possibility of allergic reactions, local irritation, and inflammation in tissues and organs, Baxter added. "There have been no reported adverse events associated with this issue to date, and the root cause of this voluntary recall has been identified and resolved," it stated. The recall is being conducted with the knowledge of the FDA.
News For BAX From The Last 14 Days
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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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