Alfacell
Alfacell completes non-clinical section of rolling new drug application for Onconase
Published in Food and Drug Law Weekly, November 3rd, 2006
Onconase, first in class in the ribonuclease family, is currently the subject of a randomized phase III clinical trial in combination with doxorubicin as a potential treatment for patients with unresectable malignant mesothelioma (UMM).
The company will submit the chemistry, manufacturing and controls (CMC) section of the NDA after completion of a review by external regulatory consultants. The...
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