Sensorion Gets Positive Recommendation for Clinical Trial of Drug Candidate for Cisplatin-Induced Ototoxicity
Sensorion was recommended to continue the study of a drug candidate for the prevention of Cisplatin-Induced Ototoxicity (CIO).
Sensorion was recommended to continue the study of a drug candidate for the prevention of Cisplatin-Induced Ototoxicity (CIO).
Fennec Pharmaceuticals Inc announced that the FDA has accepted for filing the resubmission of its New Drug Application (NDA) for PEDMARK for the prevention of ototoxicity induced by cisplatin chemotherapy in patients one month to < 18 years of age with localized, non-metastatic, solid tumors.
Dr Amy Sapodin said the kidney and the ear are structurally, functionally, and biologically similar, so conditions that affect one may affect the other. Some of these issues can begin as early as in utero.
This half-day event follows the Food and Drug Administration’s (FDA) model for externally-led Patient Focused Drug Development meetings and serves to inform the agency’s regulatory decision-making in pediatric oncology.
Read MoreMuch of Dr He’s research will focus on inner and outer hair cells, the two types of receptor cells that convert sound into electrical impulses in the auditory nerve. He will compare the changes at the cellular and molecular levels of hair cells between young and aging mice to determine age-related changes in gene expression, ultrastructure, and cellular function.
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