Drugs

FDA Awards $16 Million in Rare Disease Treatment Grants

FDA has awarded six new clinical trial research grants to principal investigators from academia and industry worth $16 million over the next four years. The grants, awarded through the Orphan Products Grants Program, enhance the development of medical products for patients with rare diseases, an agency announcement says.

The agency says it received 47 applications that were reviewed and evaluated for scientific and technical merit by more than 90 rare disease and clinical trial experts. Grants went to:

Acuela, Inc., Seattle, WA, for a Phase 3 study of emixustat hydrochloride to treat Stargardt disease;
Fred Hutchinson Cancer Research Center, Seattle, WA, for a Phase 2 study of ustekinumab for preventing graft versus host disease;
Seattle Children’s Hospital, Seattle, WA, Phase 1b study of IV gallium nitrate for treating cystic fibrosis patients colonized with nontuberculosis mycobacterium;
State University of New York Stony Brook, Stony Brook, NY, Phase 1 study of CD4 redirected chimeric antigen receptor T cell therapy for treating CD4 positive T cell neoplasms;
University of Cincinnati, Cincinnati, OH, Phase 1/2 study of ABTLo812 (a small molecule with anti-cancer activity) for treating pancreatic cancer; and
University of Virginia, Charlottesville, VA, Phase 2 study of oral azacytidine plus romidepsin for treating peripheral T cell lymphoma.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome