CTI to re-submit pixantrone NDA to FDAs Workplace of New Drugs for re-review Cell Therapeutics.

The median duration of response was 9.9 months . Grade 3 and higher adverse events occurred in 90 percent of patients in the analysis, with myelosuppression becoming the main toxicity experienced .. CTI to re-submit pixantrone NDA to FDA’s Workplace of New Drugs for re-review Cell Therapeutics, Inc. today announced that any office of New Medications of the U.S. Initial, the submission of information regarding the circumstances surrounding your choice of stopping the trial early to make sure that ongoing results assessment weren’t dictating the decision to stop and, second, ascertainment of the soundness of the primary endpoint after yet another independent radiologic review.The compound lately completed a Phase 1 clinical trial and is certainly in preparation for a Phase 2 trial in moderate to moderately-severe community-acquired bacterial pneumonia. ‘The rise of multidrug-resistant organisms has become an increasing public health issue, for vulnerable individual populations including those with challenging respiratory infections particularly,’ said Prabhavathi Fernandes, Ph.D., CEO of Cempra Pharmaceuticals. ‘New medicines are needed that are effective and safe against these difficult-to-deal with pathogens. We think that the growing database displaying the potency and broad-spectrum activity of CEM-101, not only against the pneumococcal strains presented here, but against a number of various other pathogens, indicates the potential of CEM-101 as another go-to antibiotic for clinicians.’..