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News Breaks
June 2, 2014
07:00 EDTALXNAlexion initiates voluntary recall of certain lots of Soliris
Alexion Pharmaceuticals announced that it is initiating a voluntary recall of certain lots of Soliris 300 mg/30 mL concentrated solution for intravenous infusion that were manufactured using a process component during vial filling identified in the November 2013 recall to the hospital/user level. As previously stated, Alexion believes that it has identified the process component that resulted in the presence of the visible particles and implemented a change to the process. Alexion does not anticipate any interruption to patient supply. This recall has been initiated due to the presence of visible proteinaceous particles detected in a single lot during periodic stability testing for Soliris. This lot was distributed only in the U.S. No safety risks to patients who have received Soliris have been identified. There is no financial impact from the voluntary recall. Following this voluntary recall, there will no longer be Soliris in the U.S. manufactured using the previously identified process component that Alexion believes resulted in the stability failure.
News For ALXN From The Last 14 Days
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September 17, 2014
07:34 EDTALXNAlexion names Hallal COO, Carmichael Chief Human Resources Officer
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07:33 EDTALXNAlexion names Hallal COO, Carmichael Chief Human Resources Officer
September 14, 2014
17:44 EDTALXNAlexion presents data on pediatric HPP patients treated with asfotase alfa
Alexion Pharmaceuticals announced that researchers presented new data from an integrated analysis of survival from two open-label, Phase 2 studies of asfotase alfa in pediatric patients with hypophosphatasia, HPP, compared with data from a retrospective natural history study of untreated historical control patients matched for age and disease severity. In this analysis, survival in patients with HPP at high risk of death who were treated with asfotase alfa for up to five years was significantly improved compared with untreated historical control patients.These late-breaking results were presented at the American Society for Bone and Mineral Research, ASBMR, 2014 Annual Meeting in Houston, where researchers also presented new data from the ongoing open-label extension phases of two Phase 2 clinical studies in which sustained gains in physical function and reductions in disability and pain were observed in pediatric patients receiving asfotase alfa treatment for up to three years.
September 12, 2014
07:14 EDTALXNAmerican Society for Bone & Mineral Research holds annual meeting
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September 8, 2014
06:31 EDTALXNAlexion announces asfotase alfa granted orphan drug designation in Japan
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