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News Breaks
May 5, 2014
06:33 EDTALXNAlexion's Soliris approved by FDA from accelerated to regular approval
Alexionís supplemental Biologics License Application providing regular approval for Soliris for the treatment of adult and pediatric patients with atypical hemolytic uremic syndrome to inhibit complement-mediated thrombotic microangiopathy has been approved by the FDA. This update reflects Alexionís fulfillment of post-marketing requirements, including the submission of confirmatory data from two additional prospective clinical trials, including one in pediatric patients with aHUS. The revised label now specifies important longer-term clinical benefit associated with chronic and sustained Soliris treatment with inclusion of results with two years of ongoing treatment in aHUS patients. The updated label also includes data on the use of Soliris treatment prior to use of supportive care with either plasma exchange or plasma in prospective clinical trials.
News For ALXN From The Last 14 Days
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December 15, 2014
06:31 EDTALXNAlexion announces $500M share repurchase program
Alexion Pharmaceuticals announced that the companyís board has authorized a new share repurchase program of up to $500M. The new share repurchase program will take effect upon completion of the companyís current program, which has approximately $22M remaining of its previously authorized $400M.
December 12, 2014
08:01 EDTALXNPiper predicts two large-cap biotechs could be acquired in 2015
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December 10, 2014
16:20 EDTALXNAlexion reports Soliris granted orphan drug designation in Japan
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December 9, 2014
05:33 EDTALXNAlexion presents Soliris data at ASH
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December 7, 2014
14:10 EDTALXNAmerican Society of Hematology to hold a meeting
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