Drugs

FDA Expanding CURE ID

FDA says it is expanding CURE ID, a joint initiative with the National Center for Advancing Translational Sciences/National Institutes of Health, which is an Internet-based repository that allows the global community to report novel uses of existing drugs for difficult-to-treat diseases. In a “Q&A with FDA” podcast, Office of Medical Policy health science policy analyst Heather Stone and Critical Path Institute CURE Drug Repurposing Collaboratory executive director Marco Schito discuss the beginnings of CURE ID, the way that it works, and FDA’s expansion plans.

CURE ID allows healthcare providers, patients, and care partners to share their real-world treatment experiences with repurposed drugs. Users can find new ways of treating diseases, new combinations of drugs that are useful, new dosing regimens and durations of therapy, new populations that can benefit from existing treatments, or even that unapproved uses don’t work or are harming patients.

Stone says CURE ID initially focused on infectious diseases and was very useful in the Covid-19 pandemic. It can be deployed for future infectious diseases, she says, and is currently in trials for sepsis and meningitis.

Schimo reports that a complementary oncology platform is being developed and that CURE ID is being developed to address the needs of special populations and to address chronic illnesses.

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