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January 23, 2013
14:55 EDTALXNAlexion informed Health Ministers will not follow AGNSS Soliris recommendation
Alexion Pharma UK, a subsidiary of Alexion Pharmaceuticals, announced it has been informed by the National Specialised Commissioning Team that the Ministers of Health have decided to not follow a positive recommendation by the Advisory Group for National Specialised Services, or AGNSS, when assessing Soliris as a treatment for patients with atypical haemolytic uraemic syndrome. The Ministers of Health have overruled this expert committee recommendation and instead referred consideration of Soliris for the treatment of patients with aHUS to the National Institute for Health and Clinical Excellence. Alexion said it is committed to working with the Health Ministers to make Soliris available to children and adults as quickly as possible, and calls upon the Ministers to accept the recommendation of the significant number of experts and lay people called upon to review Soliris without delay, and to reverse his decision and accept the recommendation of AGNSS in the best interests of aHUS patients in England. Alexion said, "It is important to underscore that the UK Government developed a specific process and authorised a committee, AGNSS, to evaluate treatments addressing patients with very rare disorders, and that AGNSS concluded that 'eculizumab should be routinely nationally commissioned for patients with aHUS.'"
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April 24, 2014
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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