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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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May 21, 2015
09:05 EDTBAXBaxter files for European approval of investigational IGSC 20% treatment for PI
Baxter International announced that its BioScience business has submitted a marketing authorization application to 17 competent authorities in Europe following the decentralized procedure for approval of its investigational 20% concentration subcutaneous immune globulin, or IGSC, treatment for primary immunodeficiencies, or PI, a group of disorders in which part of the body's immune system is missing or does not function properly. Results from a separate study of IGSC 20% among patients with PI in North America are expected to be available in the coming months; based on the outcome of this study, Baxter intends to file for U.S. approval of the treatment before the end of 2015.
06:38 EDTBAXNovo Nordisk rejects claims made by Baxter, Reuters says
Novo Nordisk (NVO) rejects claims made by Baxter (BAX) that the company used substances made by Baxter in its Novoeight haemophilia treatment, following Monday's ITC investigation announcement, reports Reuters, citing an email from Novo Nordisk. Reference Link
May 18, 2015
12:24 EDTBAXBaxter sees FY16 sales growth 2%-3%
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12:20 EDTBAXBaxter sees 2H sales growth approximately flat in constant currency
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08:39 EDTBAXBaxter says Baxalta separation on-track for mid-year 2015
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May 15, 2015
17:31 EDTBAXBaxter gets FDA approval for Spain facility to produce Sodium Chloride Injection
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