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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.”
News For BAX From The Last 14 Days
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October 30, 2014
09:02 EDTBAXBaxter presents IGSC 20% Phase 2,3 study
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October 27, 2014
07:23 EDTBAXAmerican College of Surgeons holds a conference
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07:22 EDTBAXAmerican College of Chest Physicians to hold a conference
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October 24, 2014
09:02 EDTBAXBaxter says FDA approves Obizur for acquired hemophilia A
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October 21, 2014
06:29 EDTBAXBaxter management to meet with Leerink
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October 20, 2014
09:04 EDTBAXBaxter, Halozyme launch HYQVIA in U.S.
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October 16, 2014
09:04 EDTBAXBaxter says spin-off of BioScience division on track for mid-2015 completion
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09:02 EDTBAXBaxter says it still has not experienced competition for cyclophosphamide
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08:38 EDTBAXBaxter expects divestiture of vaccines business to Pfizer to close in Q4
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07:03 EDTBAXBaxter sees FY14 continuing ops EPS $4.86-$4.89, consensus $5.16
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07:02 EDTBAXBaxter sees Q4 continuing ops EPS $1.30-$1.33, consensus $1.41
Sees Q4 sales growth approx. 3% excluding the impact of foreign currency. Including the impact of foreign currency, the company expects reported sales to be flat to 2013 levels. Consensus is $4.39B.
07:01 EDTBAXBaxter reports Q3 adjusted EPS $1.35, consensus $1.31
Reports Q3 revenue $4.2B, consensus $4.2B.

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