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August 25, 2014
07:52 EDTALXNAlexion says Soliris production not interrupted by FDA facility inspection
From August 18 through August 22, the U.S. Food and Drug Administration inspected Alexion's Smithfield, Rhode Island manufacturing facility. As previously disclosed, Alexion had earlier received an FDA Warning Letter, dated March 22, 2013, regarding compliance with current Good Manufacturing Practices at the Rhode Island facility. At the conclusion of the August inspection, the FDA issued a Form 483 with three inspectional observations, none of which was designated as a repeat observation to the March 22, 2013 Warning Letter. These observations are inspectional, and do not represent a final FDA determination of compliance. The three observations include a need for enhanced training around gowning procedures, more frequent environmental monitoring, and processes related to identification of the definitive root cause of a prior bioburden excursion. Addressing FDA observations and advancing quality initiatives has been a key priority for Alexion and the company has enhanced and expects to continually enhance its overall quality program. The company will continue to work diligently to address the observations identified in the Form 483. Alexion continues to manufacture products, including Soliris in this facility. Based on current information, Alexion believes that the supply of Soliris to patients will not be interrupted. Based on current information, Alexion does not believe there will be any material financial impact to address the observations and resolve outstanding FDA concerns. Unless and until Alexion is able to correct outstanding issues to the FDA’s satisfaction, the FDA may withhold approval of requests for export certificates for certain countries
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 company’s board has authorized a new share repurchase program of up to $500M. The new share repurchase program will take effect upon completion of the company’s 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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