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December 10, 2013
09:03 EDTBAXBaxter submits application for FDA approval of OBI-1
Baxter International announced that the company has submitted a biologics license application to the U.S. Food and Drug Administration for the approval of OBI-1, a recombinant antihemophilic porcine sequence factor VIII, in patients with acquired hemophilia A. Phase 2/3 data supporting the submission were presented at the American Society of Hematology’s 55th Annual Meeting in New Orleans, LA. The global, prospective, multi-center phase 2/3 open label clinical trial examined the efficacy and safety of OBI-1 in the treatment of serious bleeds in adults with acquired hemophilia A. Patients who presented with a serious bleed were treated with an initial dose of OBI-1, followed by additional doses based on their personal profiles, including clinical evaluations and target factor VIII activity levels. The primary efficacy endpoint of the study was defined by clinical assessment as effective or partially effective control of bleeding and FVIII activity levels at 24 hours after initiation of OBI-1 therapy. All patients in the study responded positively in the first 24 hours, based on clinical assessment and FVIII activity levels. No treatment-related serious adverse events were reported in the study. Non-serious mild adverse events related to treatment were reported in two of 18 patients. These two patients developed anti-porcine inhibitors to OBI-1. OBI-1 has been granted orphan-drug designation for acquired hemophilia A by the FDA. The application has also been granted a fast-track designation.
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April 17, 2014
11:14 EDTBAXBaxter shares attractive at current level, says Piper Jaffray
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08:52 EDTBAXBaxter expects to generate cash flow from operations of $3.5B
Expects FY14 CapEx $1.8B, which includes Gambro in the investments. Sees FY14 R&D to grow in mid single digits and SG&A to grow in mid to high single digits. Sees FY14 tax rate of 231.5%. Expects FY14 Medical Products sales growth of 13%-14%. Expects FY14 Fluid Systems sales to decline 3%-5%. Expects sales growth for BioScience to reach 3%-4%. Comments taken from Q1 earnings conference call.
07:04 EDTBAXBaxter reports Q1 BioScience revenue $1.61B
Reports Q1 Medical Products sales $2.34B.
07:03 EDTBAXBaxter sees Q2 EPS before special items $1.18-$1.22, consensus $1.28
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07:03 EDTBAXBaxter sees FY14 EPS before special items $5.05-$5.25, consensus $5.13
Sees FY14 sales growth 9%-10%, before the impact of foreign exchange, consensus $16.6B. Sees FY cash flow from operations approx. $3.5B.
07:01 EDTBAXBaxter reports Q1 adjusted EPS $1.19, consensus $1.09
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April 16, 2014
08:48 EDTBAXBaxter says meets primary endpoint in Phase 3 BAX 111 trial
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April 8, 2014
07:22 EDTBAXCaSA-ISPE to hold a conference
21st Annual Lilfe Sciences Technology Conference is being held in Raleigh, North Carolina on April 8.
April 3, 2014
07:01 EDTBAXKamada announces U.S. proof-of-concept study with Glassia
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