Drugs

Organs-on-a-Chip Could Change Drug Testing

CNBC profiles several firms that are developing human organs on chips — miniaturized versions of livers, lungs, kidneys, intestines, and others that “may offer a less time-consuming and costly way to test drugs, foods, cosmetics, and dietary supplements for efficacy and toxicity, with the goal of vastly improving upon traditional cell culture and animal-based methods.” The report says that in addition to increasing the speed and accuracy of drug testing, organs-on-chips present a range of game-changing potentials. For example, they could be embedded with a particular disease like cancer to give researchers a cost-effective mini laboratory for introducing immune cells or drugs and observing reactions in real time.

“While this technology is extremely promising, using organ chips in clinical trials is still a decade or so away,” the report says. “Ironically, a breakthrough that should accelerate the drug approval process is subject to the rigorous regulatory system. Even before FDA considers okaying organ chips for clinical trials on new drugs, the agency recently signed a multi-year research and development agreement with Emulate to validate (that company’s) organs-on-chips technology for possible use in testing ingredients in food, cosmetics, and dietary supplements. The project will begin with a liver chip.”

“The liver is particularly susceptible to organ toxicity, as it is the site of toxin filtration and metabolic breakdown,” said FDA Center for Food Safety and Applied Nutrition Office of Applied Research and Safety Assessment director Robert Sprando, “so we thought that the liver chip would be an appropriate place to start. Initially, we have to do an evaluation of the technology, because one of the questions is how this can be used in a regulatory environment.”

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