Drugs

FDA Partnership on Rare Neurodegenerative Diseases

FDA says it is joining the National Institutes of Health in launching the Critical Path for Rare Neurodegenerative Diseases, a public-private partnership to advance the understanding of neurodegenerative diseases and foster the development of treatments for amyotrophic lateral sclerosis and other such diseases. An announcement says the two agencies have selected the Critical Path Institute (C-Path) to convene the partnership.

C-Path will bring together experts in rare neurodegenerative diseases including patient communities, advocacy organizations, and private entities, the announcement says. The direction and priorities for the effort will be determined with input from the partners. Areas of focus are expected to include patient-focused drug development and the use of the FDA-funded Rare Disease Cures Accelerator-Data and Analysis Platform to bring together scientific data on rare neurodegenerative diseases to facilitate the characterization of neurodegenerative diseases and their natural history, the identification of molecular targets for neurodegenerative diseases, and increased efficiency, predictability, and productivity of clinical development of therapies.

“Building on and leveraging the shared expertise of the participants,” FDA says, “the goal of this partnership is to generate actionable solutions that can tangibly accelerate drug development for rare neurodegenerative diseases.”

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

Read more

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