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News Breaks
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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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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