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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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July 25, 2014
07:44 EDTALXNAlexion valuation looking increasingly compelling, says Stifel
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July 24, 2014
11:53 EDTALXNAlexion price target raised to $214 from $196 at Piper Jaffray
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06:43 EDTALXNAlexion raises 2014 adjusted EPS view to $4.95-$5.05 from $4.75-$4.85
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06:41 EDTALXNAlexion reports Q2 adjusted EPS $1.12, consensus $1.07
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06:17 EDTALXNAlexion's hypophosphatasia candidate MAA accepted by European Medicines Agency
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July 22, 2014
11:48 EDTALXNStocks with call strike movement; EXPE ALXN
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July 16, 2014
10:01 EDTALXNPegasystems appoints Warner Chief Compliance Officer
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08:01 EDTALXNAlexion names former AstraZeneca CEO David Brennan to board
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