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News Breaks
October 25, 2013
09:09 EDTBAXCHMP recommends granting extensions of indications to 2 Baxter vaccines
The Committee for Medicinal Products for Human Use adopted a positive opinion recommending a variation to the terms of the marketing authorization for the medicinal product Vepacel. The marketing authorization holder for this medicinal product is Baxter Innovations GmbH. The CHMP adopted a new indication as follows2: "Active immunisation against H5N1 subtype of influenza A virus. This indication is based on immunogenicity data from subjects from the age of 6 months onwards following administration of two doses of vaccine prepared with H5N1 subtype strains. VEPACEL should be used in accordance with Official guidance". The CHMP also adopted a positive opinion recommending a variation to the terms of the marketing authorization for the medicinal product Pandemic Influenza Vaccine H5N1 Baxter. The CHMP adopted a new indication to include children and adolescents from the age of 6 months onwards. The full indication for Pandemic Influenza Vaccine H5N1 Baxter will be as follows: “Prophylaxis of influenza in an officially declared pandemic situation. Pandemic influenza vaccine should be used in accordance with official guidance.”
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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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