Mar

3

NDA Submitted – BLA Approved That Used Target e*CRF®

Filed Under What's New 

This past week, FDA announced (click here) the approval of ARCALYST™ (rilonacept, Regeneron Pharmaceuticals) for the treatment of rare inflammatory syndromes. In addition, Ferring Pharmaceuticals announced that it has submitted applications in Europe and the United States for the marketing authorization of its prostate cancer treatment, degarelix, a new GnRH receptor blocker intended for patients in whom androgen deprivation is warranted.

We are very pleased to announce that Target e*CRF® was used for the clinical trials for both submissions. There are now 14 products (NDA-2; PMA-10; BLA-1; and 510k-1) with FDA marketing approval that used Target e*CRF® for their pivotal trials. All of these studies passed FDA pre-approval inspection audits. Currently there is one NDA and one PMA in review.

For more information, please contact Dr. Jules T. Mitchel or Joyce Hays. For new business opportunities, contact Dr. Jules T. Mitchel

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