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June 3, 2014
09:02 EDTBAXBaxter presents efficacy and safety data on VIVIA system at ERA-EDTA Congress
Baxter International announced the presentation of clinical data supporting the safety and efficacy of the VIVIA haemodialysis system. Results from two studies conducted in a clinical setting showed acceptable clearance of uremic toxins and an overall safety profile similar to that associated with conventional HD devices. The VIVIA system, designed to deliver High Dose HD in the home, completed the CE marking process in Europe, December 2013. The first in-human study was a prospective, single arm clinical study (Abstract #SP415) conducted in haemodialysis centres in the United States, in which 22 patients received four HD treatments with the VIVIA HD system every week for 10 weeks. The mean duration of each HD treatment was 3.8 hours. A mean weekly standard measure of urea clearance and dialysis adequacy, was 2.97. No device-related serious adverse events occurred during the study. The feasibility of multiple use of the same dialyser on the same patient was also established.
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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 companyís 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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