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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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July 31, 2014
14:00 EDTBAXBaxter, Halozyme announce favorable FDA panel recommendation on HyQvia
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12:39 EDTBAXFDA panel says HyQvia has favorable benefit-risk ratio, Bloomberg reports
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07:10 EDTBAXFDA Blood Products Advisory Committee to hold a meeting
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July 30, 2014
08:08 EDTBAXBaxter announces divestiture of commercial vaccines business to Pfizer for $635M
Baxter International (BAX) announced that it has entered into a definitive agreement to sell its two commercially marketed vaccines and related production facilities to Pfizer (PFE) for a total cash consideration of $635M, subject to certain adjustments. The sale includes the company’s commercial vaccines business, which is comprised of NeisVac-C, a vaccine which helps protect against meningitis caused by group C meningococcal meningitis, and FSME-IMMUN, which helps protect against tick-borne encephalitis, an infection of the brain transmitted by the bite of ticks infected with the TBE-virus. Both vaccines are currently available outside the United States, primarily in a number of European markets. Baxter continues to explore strategic options, including the potential for partnering or divesting its R&D development programs focused on influenza and Lyme disease. Subject to regulatory approvals and other customary closing conditions, the companies expect to close the transaction by the end of 2014. Baxter expects 2014 vaccines revenues to total approximately $300M and adjusted earnings of approximately 25c per diluted share, including approximately $50M of one-time milestone payments related to the ongoing government collaborations for development of influenza vaccines. Baxter expects the transaction to be modestly dilutive to fourth quarter 2014 adjusted earnings and dilutive to 2015 adjusted earnings by approximately 15c per diluted share.
08:01 EDTBAXPfizer enters into agreement to acquire Baxter's portfolio of marketed vaccines
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