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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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November 20, 2014
07:09 EDTALXNAlexion management to meet with Deutsche Bank
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November 19, 2014
10:28 EDTALXNAlexion management to meet with Deutsche Bank
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November 18, 2014
07:52 EDTALXNFDA Drug Safety & Risk Management Advisory Committee to hold a meeting
The Committee discusses the risk management of Alexion Pharmaceuticals' Eculizumab (Soliris) is a meeting being held at FDA Silver Spring, Maryland offices on November 18 at 9 am. Webcast Link
November 16, 2014
13:04 EDTALXNAlexion says data supports effectiveness of sustained Soliris treatment in aHUS
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November 10, 2014
15:54 EDTALXNAmerican Society of Nephrology to hold a conference
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09:20 EDTALXNJPMorgan biotech analyst to hold an analyst/industry conference call
U.S. SMid Biotech Analyst Rama, along with Key Opinion Leader Dr. Hickman Simmons from Vanderbilt University, discuss Alexion Pharmaceuticals' Asfotase Alfa and Hypophosophatasia on an Analyst/Industry conference call to be held on November 11 at 11 am.
06:31 EDTALXNAlexion announces planned retirement of co-founder, COO Stephen Squinto
Alexion announced the planned retirement of company co-founder Stephen Squinto, effective January 1, 2015. Squinto currently serves as Executive Vice President, Chief Global Operations Officer. He co-founded Alexion in 1992 with Leonard Bell, M.D., the Company’s principal founder and current Chairman and Chief Executive Officer.

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