Drugs

FDA Looking at Mitochondrial Drugs and Cancer Cells: Spotlight

CDER Office of Pharmaceutical Quality scientists are looking into the biochemical reactions of cancer cells to certain drugs that are designed to penetrate into subcellular structures known as mitochondria. An online Spotlight on CDER Science says that drugs that selectively enter and damage the mitochondria of cancer cells are of interest to many drug developers and biomedical scientists. The agency investigators say that cancer cells may thwart this strategy by employing a multi-step process called mitophagy through which they isolate and destroy such damaged mitochondria in order to survive.

“CDER scientists want to understand mitophagy in cancer cells and determine how the removal of damaged mitochondria by mitophagy contributes to drug resistance during chemotherapy,” the post says. The Spotlight says that the agency research into the effects of mitochondrial drugs on cancer cells “establishes a quantitative and reliable new analytical test for measuring the effects of drugs on mitophagy. This new methodology offers drug developers the opportunity to explore and target mitochondrial functions in cancer and a variety of other 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

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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