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April 16, 2014
08:48 EDTBAXBaxter says meets primary endpoint in Phase 3 BAX 111 trial
Baxter International announced topline results from a Phase 3 clinical trial evaluating the safety, efficacy and pharmacokinetics of BAX 111. BAX 111 is a recombinant von Willebrand factor under investigation for the treatment of bleeding episodes in patients with von Willebrand disease, the most common type of inherited bleeding disorder. The study of BAX 111, the first recombinant treatment in clinical development for this condition, met its primary efficacy endpoint, as all patients achieved pre-specified success in the on-demand treatment of bleeding events. The Phase 3 multicenter, open-label clinical trial assessed the safety, efficacy and pharmacokinetics of BAX 111 administered together with ADVATE or as a stand-alone therapeutic agent in the on-demand treatment of 37 patients with severe von Willebrand disease at trial sites in the United States, Europe, Australia, Japan, Russia and India. The primary endpoint was the number of patients experiencing successful treatment for bleeding episodes. Secondary endpoints included additional efficacy and safety measures, pharmacokinetics and health-related quality of life. There were no reports of inhibitor development or thrombotic events in the study participants. The most common adverse events in the study were headache, vomiting/nausea and anemia (iron deficiency anemia), which were not considered to be related to treatment. There was one serious adverse event related to treatment, characterized by chest discomfort and increased heart rate during infusion, which rapidly resolved without further complication. The investigational treatment was developed using a plasma- and albumin-free manufacturing method.
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January 29, 2015
07:13 EDTBAXBaxter sees Q1 adjusted EPS 85c-90c, consensus $1.03
Sees Q1 sales growth of approximately 2%-3%, excluding the impact of foreign currency. Including the impact of foreign currency, the company expects sales to decline approximately 3%-4%. Consensus $3.72B.
07:04 EDTBAXBaxter reports Q4 adjusted EPS $1.34, consensus $1.31
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January 28, 2015
15:38 EDTBAXNotable companies reporting before tomorrow's open
Notable companies reporting before tomorrow's market open, with earnings consensus, include Celgene (CELG), consensus 99c... ConocoPhillips (COP), consensus 59c... Abbott Laboratories (ABT), consensus 67c... Occidental Petroleum (OXY), consensus 68c... Colgate-Palmolive (CL), consensus 74c... Ford (F), consensus 23c... Dow Chemical (DOW), consensus 69c... Alibaba (BABA), consensus 75c... Thermo Fisher (TMO), consensus $1.94; Time Warner Cable (TWC), consensus $2.09... Phillips 66 (PSX), consensus $1.34... Alexion Pharmaceuticals (ALXN), consensus $1.29... Baxter International (BAX), consensus $1.31... Cardinal Health (CAH), consensus $1.10... Raytheon (RTN), consensus $1.08... Northrop Grumman (NOC), consensus $2.25... Viacom (VIAB), consensus $1.28... Valero Energy (VLO), consensus $1.32... Sherwin-Williams (SHW), consensus $1.38... Hershey (HSY), consensus $1.06... Mead Johnson (MJN), consensus 88c... Zimmer (ZMH), consensus $1.71... Xcel Energy (XEL), consensus 34c... Royal Caribbean (RCL), consensus 42c... Coach (COH), consensus 66c... Kate Spade (KATE), consensus 24c... Harley-Davidson (HOG), consensus 34c... Stanley Black & Decker (SWK), consensus $1.52... L-3 Communications (LLL), consensus $2.27... JetBlue (JBLU), consensus 24c.
January 26, 2015
07:17 EDTBAXSociety of Thoracic Surgeons to hold annual meeting
51st Annual Meeting of STS is being held in San Diego, California on January 24-28.
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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