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News Breaks
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 FDAs 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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October 23, 2014
06:38 EDTALXNAlexion raises 2014 adjusted EPS view to $5.15-$5.20 from $4.95-$5.05
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06:36 EDTALXNAlexion reports Q3 adjusted EPS $1.27, consensus $1.16
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October 22, 2014
15:37 EDTALXNNotable companies reporting before tomorrow's open
Notable companies reporting before tomorrow's market open, with earnings consensus, include Comcast (CMCSA), consensus 71c; Union Pacific (UNP), consensus $1.52; 3M (MMM), consensus $1.96; AbbVie (ABBV), consensus 77c; Celgene (CELG), consensus 95c; Eli Lilly (LLY), consensus 67c; Occidental Petroleum (OXY), consensus $1.57; Caterpillar (CAT), consensus $1.36; Alexion Pharmaceuticals (ALXN), consensus $1.16; Precision Castparts (PCP), consensus $3.32; Raytheon (RTN), consensus $1.60; American Electric Power (AEP), consensus $1.02; Southwest Airlines (LUV), consensus 53c; Lorillard (LO), consensus 90c; T. Rowe Price (TROW), consensus $1.15; Mead Johnson (MJN), consensus 91c; Zimmer Holdings (ZMH), consensus $1.30; Nucor (NUE), consensus 73c; Nielsen (NLSN), consensus 65c; Prologis (PLD), consensus 46c; Sigma-Aldrich (SIAL), consensus $1.06; Under Armour (UA), consensus 40c; EQT (EQT), consensus 56c; Dr Pepper Snapple (DPS), consensus 88c; Cameron International (CAM), consensus $1.10; Coca-Cola Enterprises (CCE), consensus 89c; Quest Diagnostics (DGX), consensus $1.08; CMS Energy (CMS), consensus 41c; Airgas (ARG), consensus $1.29; PulteGroup (PHM), consensus 36c; Diamond Offshore (DO), consensus 79c; Bemis (BMS), consensus 67c.
October 20, 2014
07:19 EDTALXNIBC Life Sciences to hold a conference
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07:10 EDTALXNAmerican Society of Human Genetics to hold annual meeting
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October 15, 2014
06:35 EDTALXNAlexion submits NDA in Japan for treatment of hypophosphatasia
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