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November 4, 2012
11:02 EDTALXNAlexion:Data show substantial improvement with Soliris in patients with STEC-HUS
Alexion Pharmaceuticals announced the presentation of 28-week data from all enrolled patients in a multi-center trial of eculizumab, Soliris, in patients who developed Shiga-toxin-producing E. coli hemolytic uremic syndrome, STEC-HUS, during an outbreak in Germany from May 2011 to July 2011. In the study, eculizumab therapy was associated with rapid and sustained clinical improvements in thrombotic microangiopathy, TMA, and systemic organ complications. The study met its primary endpoint of global assessment of efficacy at 8 weeks with 94% of patients achieving a complete or partial response in systemic TMA and vital organ involvement. Key secondary endpoints were also met with high clinical and statistical significance, including global assessment of efficacy at 28 weeks as well as improvement in hematologic, renal and neurologic functions. Preliminary findings from an exploratory post hoc, matched-control analysis of patients with severe STEC-HUS receiving eculizumab versus other patients who received current best supportive care during the German epidemic were also reported, and showed that eculizumab treatment was associated with consistently higher rates of renal and neurological function improvement at weeks 8 and 28.1
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February 27, 2015
07:23 EDTALXNAlexion receives CHMP positive opinions for updates to EU label for Soliris
Alexion announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a Positive Opinion to update the therapeutic indication for Soliris in the treatment of paroxysmal nocturnal haemoglobinuria for patients with high disease activity regardless of history of transfusion. The CHMP also issued a Positive Opinion to update the EU label for Soliris with additional data on the benefits of long-term treatment and the risks associated with treatment discontinuation in patients with atypical haemolytic uremic syndrome. If approval is granted, updated information for the use of Soliris in both PNH and aHUS will be detailed in the Summary of Product Characteristics which will be published in the revised European Public Assessment Report. The CHMP based its opinion on efficacy and safety data from an observational, non-interventional international PNH Registry, which confirmed that patients with no history of transfusion who were treated with Soliris had a significant reduction in haemolysis and associated clinical symptoms, such as fatigue.
February 23, 2015
07:22 EDTALXNSunTrust to hold a conference
2015 Biotechnology and Pharmaceutical 1:1 Orphan Drug Day is being held in New York on February 23.
February 18, 2015
11:02 EDTALXNAlexion management to meet with SunTrust
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