Assorted news from the last week: This year’s Cancer Grand Challenges (funded by Cancer Research UK and the National Cancer Institute) include a category for Solid Tumors in Children. Contract Research Organization PRA Health Sciences published a white paper encouraging industry sponsors to identify, seek out, and partner with patient organizations as they try to meet the demands of the RACE for Children Act. OncoHeroes BioSciences announced that its therapeutic Volasertib received Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) to treat pediatric rhabdomyosarcoma and other rare soft tissue sarcomas. Cooking up Change launched this video and a […]
Read moreAssorted news from the last week: Researchers at Baylor College of Medicine and the University of North Carolina at Chapel Hill have genetically modified human NKT cells with a chimeric antigen receptor (CAR) that enables them to specifically recognize and attack neuroblastoma, a form of childhood cancer. In a recent Journal of Clinical Oncology article, members from the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) expressed the need for trial sponsors to coordinate their submissions of initial pediatric study plans (iPSP) and pediatric investigation plans (PIP) with regulatory authorities in order to facilitate pediatric cancer drug […]
Read moreAssorted news from the last week: Twenty percent of children treated with drugs called anthracyclines go on to suffer heart failure later in life. Dr. Greg Aune explores why. Research to develop a new treatment and bring a new drug to market is extremely expensive, and conventional methods for obtaining funding aren’t adequate. New funding models can help disease-focused nonprofit research foundations play a central role in raising capital and mobilizing an ecosystem focused on controlling and curing a disease. The U.S. Senate unanimously passed S.Res.742 – A Senate Resolution designating September as National Childhood Cancer Awareness Month. Senators Manchin […]
Read moreGuidances Acute Myeloid Leukemia: Developing Drugs and Biological Products for Treatment Pediatric Study Plans: Content of and Process for Submitting Initial Pediatric Study Plans and Amended Initial Study Plans Cancer Clinical Trial Eligibility Criteria: Minimum Age Considerations for Inclusion of Pediatric Patients Meetings 15 Sep: Pediatric Advisory Committee Will discuss pediatric-focused safety reviews for medications related to acute dystonia associated with ADHD, acute hyperkinetic movement disorder associated with combined use of ADHD stimulants and antipsychotics 22-23 Oct: Pediatric Dose Selection Public Workshop ($50) Will discuss current methods and future approaches, and how to address gaps in pediatric dose selection that […]
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