The U.S. Centers for Medicare and Medicaid Services will convene its annual town hall meeting to discuss fiscal 2021 applications for add-on payments for new medical services and technologies, including qualified infectious disease products, Dec. 16 and 17 at the agency's headquarters in Baltimore. Those who wish to present at the meeting must register by Nov. 18; written comments should be sent to the agency by Nov. 25, according to a notice in the Federal Register. The meeting will be webcast, but those who plan to attend in person should register by Dec. 9.
The FDA awarded 12 clinical trial research grants to companies and research institutions, totaling more than $15 million over the next four years, through the Orphan Products Clinical Trials Grants Program. Funded by Congress, the program is designed to encourage clinical development of drugs, biologics, medical devices and medical foods aimed at treating rare diseases. The FDA received a total of 89 grant applications, reviewed by rare disease experts, including members of academia. Industry awardees are: Chemocentryx Inc. with $1 million over two years to fund a phase II study of avacopan for treating complement 3 glomerulopathy; Cumberland Pharmaceuticals Inc., which will receive $1 million over three years to fund a phase II study of oral ifetroban in cardiomyopathy associated with Duchenne muscular dystrophy; Privo Technologies LLC, which was awarded $2 million over four years for a phase I/II study of a cisplatin patch (PRV-111) to treat oral cancer; and Targeted Therapy Technologies LLC, which will receive $600,000 over three years to support a phase I study of episcleral topotecan to treat retinoblastoma.
The FDA's Office of Pediatric Therapeutics will hold a public workshop at the agency's Silver Springs, Md., campus Nov. 12 to discuss pediatric patient-specific engagement in the development of clinical trial endpoints for rare diseases. Specific topics will include patients' opinions on current trial endpoints, potential areas of innovation, and ways to create processes to include pediatric patients and their caregivers as collaborators in endpoint development in the early stages of medical product development.