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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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January 20, 2015
09:02 EDTBAXBaxter receives FDA approval for PHOXILLUM solution
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08:16 EDTBAXMerrimack data of Phase 3 MM-398 NAPOLI-1 study supports development programs
Merrimack Pharmaceuticals (MACK) announced that additional analyses were presented on January 16, 2015 from the Phase 3 NAPOLI-1 study of MM-398, also known as nal-IRI, in patients with metastatic pancreatic cancer previously treated with gemcitabine-based therapy. Merrimack and Baxter International's (BAX) biopharmaceutical business are collaborating on the development and commercialization of MM-398 outside of the United States and Taiwan. PharmaEngine holds the rights to commercialize MM-398 in Taiwan. Additionally, Merrimack presented preclinical and clinical data from studies of its investigational agents MM-141 and MM-151 in pancreatic and colorectal cancer, respectively. An investigator-sponsored study of MM-398 in colorectal cancer was also presented. The extended analyses for the global NAPOLI-1 Phase 3 trial presented at ASCO GI support the robustness of the overall survival benefit of MM-398 in combination with 5-fluorouracil, or 5-FU, and leucovorin presented in June 2014, at the European Society for Medical Oncology World Congress on Gastrointestinal Cancer, or ESMO GI. The primary analysis, presented at ESMO GI, demonstrated a statistically significant advantage in overall survival with an unstratified hazard ratio of 0.67, and a median of 6.1 months for the combination of MM-398 plus 5-FU and leucovorin compared to 4.2 months in the control arm.

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