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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 FDAís 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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January 29, 2015
10:29 EDTALXNAlexion's announces better long-term sustainable tax rate, says Bernstein
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09:06 EDTALXNOn The Fly: Pre-market Movers
UP AFTER EARNINGS: Flextronics (FLEX), up 6%... Coach (COH), up 6.3%... Autoliv (ALV), up 4.3%... Dow Chemical (DOW), up 3.5%... Ford (F), up 0.8%. ALSO HIGHER: McDonald's (MCD), up 3% after announcing CEO change...Xencor (XNCR), up 19% after reporting results from two trials... Pluristem Therapeutics (PSTI), up 8% after providing update and outlook on trials and pipeline... Avon Products (AVP), up 2.3% after naming James Scully as CFO... Omeros (OMER), up 6% after 2.996M share spot secondary priced at $20.03. DOWN AFTER EARNINGS: Alibaba (BABA), down 8%... Qualcomm (QCOM), down 6.8%... Alexion (ALXN), down 1.1% after reporting fourth quarter results, fiscal 2015 guidance, and CEO appointment. ALSO LOWER: Yahoo (YHOO), down 7% following Alibaba earnings report... Venaxis (APPY), down 72% after its APPY1 Test was determined by the FDA to not meet the criteria for substantial equivalence.
06:32 EDTALXNAlexion appoints David Hallal as CEO effective April 1, 2015
Alexion announced that its board has appointed David Hallal as the companyís CEO, effective April 1, 2015. Hallal currently serves as Alexionís COO and is a director of the board. He will succeed Leonard Bell, M.D., Chairman and CEO, who will retire as CEO and continue to serve as Chairman of the Board.
06:28 EDTALXNAlexion sees FY15 non-GAAP EPS $5.60-$5.80, consensus $5.91
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06:26 EDTALXNAlexion plans to focus on serving patients with PNG and aHUS
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06:25 EDTALXNAlexion reports Q4 non-GAAP EPS $1.30, consensus $1.29
Reports Q4 revenue $599.48M, consensus $590.46M
January 28, 2015
15:38 EDTALXNNotable companies reporting before tomorrow's open
Notable companies reporting before tomorrow's market open, with earnings consensus, include Celgene (CELG), consensus 99c... ConocoPhillips (COP), consensus 59c... Abbott Laboratories (ABT), consensus 67c... Occidental Petroleum (OXY), consensus 68c... Colgate-Palmolive (CL), consensus 74c... Ford (F), consensus 23c... Dow Chemical (DOW), consensus 69c... Alibaba (BABA), consensus 75c... Thermo Fisher (TMO), consensus $1.94; Time Warner Cable (TWC), consensus $2.09... Phillips 66 (PSX), consensus $1.34... Alexion Pharmaceuticals (ALXN), consensus $1.29... Baxter International (BAX), consensus $1.31... Cardinal Health (CAH), consensus $1.10... Raytheon (RTN), consensus $1.08... Northrop Grumman (NOC), consensus $2.25... Viacom (VIAB), consensus $1.28... Valero Energy (VLO), consensus $1.32... Sherwin-Williams (SHW), consensus $1.38... Hershey (HSY), consensus $1.06... Mead Johnson (MJN), consensus 88c... Zimmer (ZMH), consensus $1.71... Xcel Energy (XEL), consensus 34c... Royal Caribbean (RCL), consensus 42c... Coach (COH), consensus 66c... Kate Spade (KATE), consensus 24c... Harley-Davidson (HOG), consensus 34c... Stanley Black & Decker (SWK), consensus $1.52... L-3 Communications (LLL), consensus $2.27... JetBlue (JBLU), consensus 24c.

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