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January 21, 2014
06:37 EDTALXNAlexion granted ODD to Soliris by FDA
Alexion Pharmaceuticals announced that the FDA has granted an orphan drug designation, or ODD, to Soliris, a first-in-class terminal complement inhibitor, for the prevention of delayed graft function, or DGF in renal transplant patients. DGF is an early and serious complication of organ transplantation that is characterized by the failure of a transplanted organ to function normally immediately following transplantation.
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April 24, 2014
08:59 EDTALXNOn The Fly: Pre-Market Movers
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06:43 EDTALXNAlexion raises 2014 adj EPS view to $4.75-$4.85 from $4.37-$4.47
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06:41 EDTALXNAlexion reports Q1 adjusted EPS $1.16 ex-items, consensus $1.26
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06:25 EDTALXNAlexion begins multinational registration trials of eculizumab
Alexion initiated a single, multinational, placebo-controlled trial to evaluate the safety and efficacy of eculizumab - Soliris - in patients with relapsing neuromyelitis optica, a life-threatening, ultra-rare neurologic disorder. Alexion also initiated a single, multinational, placebo-controlled trial in patients with refractory generalized myasthenia gravis, another rare and debilitating neurologic disorder. Currently, there are no approved treatments for NMO. Soliris is currently approved in the U.S., European Union, Japan and other countries for the treatment of patients with paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome. Soliris is not approved in any country for the treatment of NMO or MG.
April 23, 2014
07:00 EDTALXNTerrapinn to hold a conference
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06:37 EDTALXNAlexion's Soliris granted Orphan Drug Designation by European Commission
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April 10, 2014
14:17 EDTALXNAlexion volatility elevated on wide price movement into Q1
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