Aardvark released exploratory data from its stopped Phase 3 HERO trial in Prader-Willi syndrome after FDA lifted the hold, and plans a redesigned Phase 3.
|Articles|June 22, 2020
PRA Health Sciences Ready to Navigate RACE Act Requirements for Pediatric Oncology
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The Research to Accelerate Cures and Equity for Children Act(RACE)-goes into effect August 18th. The RACE Act amends the existing PREA-Pediatric Research Equity Act-and eliminates the exemption from PREA requirements for cancer drugs that have orphan status. The new law requires pediatric evaluation of new drugs intended for the treatment of adult cancers and directed at a molecular target substantially relevant to the growth or progression of pediatric cancer. A designated PRA team is ready to utilize their collective experience in pediatric clinical development to support RACE Act-focused initiatives.
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