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Article: Atlantic Research Group Successfully Completes Work on Phase III Randomized, Multi-Center Clinical Trial Facilitating Lev Pharmaceuticals' BLA Submission.
- Article from:
- Business Wire
- Article date:
- September 17, 2007
CopyrightCOPYRIGHT 2007 Business Wire. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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STAUNTON, Va. -- Atlantic Research Group ("ARG") played a critical role in the BLA submission made to the U.S. Food and Drug Administration (FDA) by Lev Pharmaceuticals.
Lev Pharmaceuticals submitted a BLA to the FDA on July 31, 2007, after the completion of the pivotal U.S. Phase III trial of C1 inhibitor for the treatment of hereditary angioedema (HAE), to be marketed as Cinryze(TM). Lev relied on ARG's experienced staff and TrialVista(TM), ARG's recently launched Clinical Trial Management System (CTMS), to assist in the timely completion of the clinical trial.
"ARG was instrumental in helping Lev Pharmaceuticals meet timelines for our BLA submission ...