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Stock Market & Financial Investment News

News Breaks
June 2, 2014
07:00 EDTALXNAlexion initiates voluntary recall of certain lots of Soliris
Alexion Pharmaceuticals announced that it is initiating a voluntary recall of certain lots of Soliris 300 mg/30 mL concentrated solution for intravenous infusion that were manufactured using a process component during vial filling identified in the November 2013 recall to the hospital/user level. As previously stated, Alexion believes that it has identified the process component that resulted in the presence of the visible particles and implemented a change to the process. Alexion does not anticipate any interruption to patient supply. This recall has been initiated due to the presence of visible proteinaceous particles detected in a single lot during periodic stability testing for Soliris. This lot was distributed only in the U.S. No safety risks to patients who have received Soliris have been identified. There is no financial impact from the voluntary recall. Following this voluntary recall, there will no longer be Soliris in the U.S. manufactured using the previously identified process component that Alexion believes resulted in the stability failure.
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March 2, 2015
06:34 EDTALXNAlexion announecs FDA granted priority review for asfotase alfa
Alexion announced that the FDA has accepted for Priority Review the Company’s Biologics License Application for asfotase alfa, an investigational, first-in-class enzyme replacement therapy for treatment of patients with infantile- and juvenile-onset hypophosphatasia. The BLA submission is supported by data from 71 treated patients with HPP enrolled in three prospective studies and their extensions, as well as two retrospective natural history studies.
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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