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News Breaks
December 9, 2013
09:07 EDTBAXBaxter files for pediatric indication of RIXUBIS
Baxter International announced that it has submitted an application to the U.S. Food and Drug Administration for a pediatric indication for RIXUBIS to treat hemophilia B. RIXUBIS was approved in the U.S. for adults with hemophilia B earlier this year and the company filed for marketing approval in Europe in November. The Phase II/III clinical trial investigated the efficacy and safety of RIXUBIS among 23 previously-treated male patients less than 12 years of age with severe or moderately severe hemophilia B. The patients were treated with a twice-weekly RIXUBIS prophylaxis regimen over six months or for a minimum of 50 exposure days. The median annualized bleeding rate was 2.0. Nine patients in the study experienced no bleeds and 23 patients were treated with 1-2 infusions. In hemostatic efficacy, RIXUBIS was rated excellent or good at resolving bleeds in 96 percent of all episodes. Of the 26 bleeds seen in the trial, only two were spontaneous. There were no reports of inhibitor development, no allergic reactions, and no thrombotic or treatment-related adverse events among the study participants.
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April 21, 2014
07:21 EDTBAXFDA Pediatric Advisory Committee to hold a meeting
The Committee discusses pediatric-focused safety reviews including MDT's Activa Dystonia Therapy, (BAX's Advate and Tisseel, NVS' Famvir, Tibotec's (JNJ subsidiary) Intelence, UCB Pharma's Keppra, MRK's Maxalt, BAYRY's Natazia, Digestive Care's Pertzye, JNJ's Prezista, BMY's Reyataz, SNY's Sklice, PFE's Torisel, Aptalis' Ultresa, and GILD's Viread in a meeting being held in Bethesda, Maryland on April 21 at 8 am. Webcast Link
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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