Other News To Note
• Gentium SpA, of Villa Guardia, Italy, said it received the Day 180 list of outstanding issues from the European Committee for Medicinal Products for Human Use in connection with the marketing authorization application for Defibrotide to treat and prevent hepatic veno-occlusive disease in adults and children undergoing hematopoietic stem cell transplantation therapy. The company said it plans to submit its responses within 60 days and, if no other issues are raised, it anticipates a drug approval as early as the third quarter.
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