Content on PharmTech.com this week ranged from fundamentals on the use of digital pathology in drug development, discussions on the use of AI in pharma, and regulatory actions impacting the industry.
News|Articles|October 17, 2013
Cornerstone Pharmaceuticals Receives FDA Orphan Drug Designation
Author(s)Pharmaceutical Technology Editors
The FDA grants Cornerstone Pharmaceuticals orphan drug designation for CPI-613 for the treatment of myelodysplastic syndrome.
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Cornerstone Pharmaceuticals previously received orphan-drug designation for the use of CPI-613 in the treatment of acute myeloid leukemia and pancreatic carcinoma. CPI-613 induces cancer-specific inhibition of pyruvate dehydrogenase and alpha ketoglutarate dehydrogenase, key mitochondrial enzymes involved in cancer-cell metabolism. CPI-613 is currently being evaluated in Phase I, I/II, and Phase II trials in hematologic malignancies and solid tumors.
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