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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 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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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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September 5, 2014
10:05 EDTALXNOn The Fly: Analyst Initiation Summary
Today's noteworthy initiations include: Actavis (ACT) initiated with a Buy at ISI Group... Akamai (AKAM) initiated with a Buy at UBS... Alexion (ALXN) initiated with a Buy at SunTrust... Allegion (ALLE) initiated with a Buy at Buckingham... Allergan (AGN) initiated with a Buy at ISI Group... Aviat Networks (AVNW) initiated with a Neutral at H.C. Wainwright... Celgene (CELG) initiated with a Buy at SunTrust... EZCORP (EZPW) initiated with a Hold at Jefferies... Eaton (ETN) initiated with a Neutral at Buckingham... Emerson (EMR) initiated with a Neutral at Buckingham... HMS Holdings (HMSY) initiated with an Overweight at Stephens... Incyte (INCY) initiated with a Buy at SunTrust... Ingersoll-Rand (IR) initiated with a Neutral at Buckingham... Insmed (INSM) initiated with an Outperform at Cowen... Intercept (ICPT) initiated with an Outperform at Cowen... Johnson & Johnson (JNJ) initiated with an Outperform at BMO Capital... Lennox (LII) initiated with a Neutral at Buckingham... Mylan (MYL) initiated with a Hold at ISI Group... Orion Engineered Carbons (OEC) initiated with a Buy at Goldman... Parker-Hannifin (PH) initiated with a Buy at Buckingham... Pentair (PNR) initiated with a Neutral at Buckingham... Pharmacyclics (PCYC) initiated with a Neutral at SunTrust... Rockwell Automation (ROK) initiated with a Neutral at Buckingham... Sabre (SABR) initiated with an Outperform at Oppenheimer... Santander Consumer (SC) initiated with a Buy at Jefferies... Springleaf (LEAF) initiated with a Buy at Jefferies... Susser Petroleum (SUSP) initiated with a Neutral at Credit Suisse... Teva (TEVA) initiated with a Buy at ISI Group... Valeant (VRX) initiated with a Buy at ISI Group... WESCO (WCC) initiated with a Neutral at Buckingham... Watsco (WSO) initiated with a Neutral at Buckingham... Weyerhaeuser (WY) initiated with a Neutral at JPMorgan... World Acceptance (WRLD) initiated with a Hold at Jefferies.
September 4, 2014
17:56 EDTALXNAlexion initiated with a Buy at SunTrust
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September 3, 2014
19:04 EDTALXNNICE recommends commissioning of Eculizumab for patients with aHUS in England
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