Drugs

New FDA Rare Disease Grants, Contracts

FDA says it has awarded new 19 new grants and two new contracts worth more than $38 million in funding over the next four years to support clinical trials, natural history studies, and regulatory science tools related to rare diseases. An agency statement says funding is from the Orphan Products Grants Program. The grants and contracts are intended to advance the development of medical products to treat rare diseases, the statement says.

Several of the awards support the Accelerating Access to Critical Therapies for Amyotrophic Lateral Sclerosis (ALS) Act, which recently established the FDA Rare Neurodegenerative Disease Grant Program to promote medical product development for rare neurodegenerative diseases such as ALS, FDA says.

The agency says it received 33 clinical trial grant applications and awarded more than $25 million spread over the next four years to 11 clinical trials that support product development for rare disease treatments. Seven of the awards fund studies of rare cancers, FDA says, mostly targeting cancers of the brain and peripheral nerves.

One of the two contacts included in this announcement is co-funded with the National Institutes of Health and will study whether a physical assessment of ALS patients, typically performed in a healthcare professional’s office, can be done remotely at home to minimize the burden on patients. The second contract is a landscape analysis of patient preference information studies focused on brain-computer interface devices. FDA says it is particularly interested in devices that communicate with the brain and provide patients who are no longer able to speak or move with the ability to interact with their families and healthcare professionals.

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