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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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September 29, 2014
06:36 EDTBAXKamada announces second extension of strategic agreement with Baxter
Kamada (KMDA) announced the second extension to supply Glassia to Baxter (BAX) in its strategic agreement with the biopharmaceutical business of Baxter. Through the extended agreement, Kamada secured $26M in additional revenues of Glassia, the company’s proprietary, ready-to-infuse liquid alpha-1 antitrypsin treatment that is indicated as a chronic augmentation and maintenance therapy in adults with clinically evident emphysema due to severe congenital AAT deficiency, through 2017. As a result, Kamada expects that total revenue generated through this agreement from October 2010 through end of 2017 will increase to a minimum of $191M compared with a minimum of $110M contained in the original agreement executed in 2010 and a minimum of $165M contained in the May 2013 extension. In addition, the company reports that the supply of Glassia to Baxter has been extended through 2017 and that the transition to royalty payments for Glassia produced by Baxter is not expected to begin before 2018. Until that time, Kamada will continue to produce Glassia for distribution by Baxter. Kamada is confident in its ability to support the increased demand from Baxter throughout the term of the amended agreement.
September 26, 2014
05:40 EDTBAXPharmaEngine, Merrimack Pharmaceuticals amend MM-398 license agreement
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September 24, 2014
09:05 EDTBAXOn The Fly: Pre-market Movers
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07:39 EDTBAXMerrimack to hold a conference call
Conference call to discuss the exclusive license and collaboration agreement with Baxter International for the development and commercialization of MM-398 also known as "nal-IRI" will be held on September 24 at 8:30 am. Webcast Link
07:06 EDTBAXBaxter, Merrimack enter exclusive ex-U.S. licensing deal for MM-398
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September 17, 2014
08:44 EDTBAXJPMorgan biotech analysts hold an analyst/industry conference call
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