Drugs

NIH Advisors Approve CRISPR Trial

A National Institutes of Health (NIH) advisory committee approved 6/21 a proposal to use the CRISPR genome-editing technology in a human trial to help augment cancer therapies that rely on enlisting a patient’s T cells. The journal Nature reports that the NIH Recombinant DNA Research Advisory Committee approved the small trial, which is designed to test whether CRISPR is safe for use in people rather than whether it efficiently treats cancer.

In the trial, to be funded by a $250 million immunotherapy foundation formed by former Facebook president Sean Parker, researchers will remove T cells from 18 patients with several types of cancers and perform three CRISPR edits on them. One edit reportedly will insert a gene for a protein engineered to detect cancer cells and instruct the T cells to target them, while a second removes a natural T cell protein that could interfere with this process. The third edit will remove the gene for a protein that identifies the T cells as immune cells and prevent the cancer cells from disabling them. The edited cells will then be returned to the patients.

A team at the University of Pennsylvania that will conduct the research now will have to convince regulators and institutional review boards to allow the trial, the report says.

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