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In a milestone for Americans with diabetes, the Food and Drug Administration (FDA) has cleared the first-ever continuous blood sugar monitoring device that doesn’t require patients to take potentially painful and invasive blood tests that require pricking their fingertips to collect samples. The approval was granted to Abbott Diabetes Care Inc.
The device, Abbott’s FreeStyle Libre Flash Glucose Monitoring System, is approved for adult diabetes patients 18 years of age and older, and the approval sent Abbott stock up 3.5% in Thursday trading. It slashes the need for the so-called fingerstick tests that people with diabetes regularly endure to figure out whether their blood sugar levels are too high or too low, and to monitor general fluctuation in blood glucose so they can adjust their diets or medication. The device itself uses an under-the-skin sensor wire which keeps tabs on sugar levels. In order to get a gauge on where those glucose levels are at, users simply have to wave an accompanying, specialized mobile reader device over the sensor like a wand.
“The FDA is always interested in new technologies that can help make the care of people living with chronic conditions, such as diabetes, easier and more manageable,” said the FDA’s Donald St. Pierre in a statement. “This system allows people with diabetes to avoid the additional step of fingerstick calibration, which can sometimes be painful, but still provides necessary information for treating their diabetes—with a wave of the mobile reader.”
Medical device and tech companies alike have shown growing interest in diabetes management and monitoring devices. Last year, the FDA approved an artificial pancreas from device giant Medtronic to treat people with type 1 diabetes with a largely automated glucose monitoring and insulin dose-adjusting system. And then there’s Apple, which made waves over the spring when reports emerged that it had hired a team of biomedical engineers to work on a blood sugar sensor of its own, possibly integrated into an Apple Watch-type device.
Read on for the day’s news.
FDA hits yet another company on manufacturing concerns, delaying Intarcia device. Intarcia Therapeutics, one of the firms featured in our recent package on companies pursuing the digital health revolution, has announced a regulatory setback. The Food and Drug Administration (FDA) rejected Intarcia’s high-tech implantable drug delivery device, ITCA 650, which the company says can continually dispense diabetes medication inside the body with minimal maintenance in any given year. The FDA cited manufacturing concerns, according to Intarcia, and the firm asserts it doesn’t expect to have to carry out new, long-winded clinical trials. Intarcia is far from the first biopharma company to get an FDA shutdown this year over manufacturing.
The world’s best-selling drug gets another cushion after Amgen deal. AbbVie’s Humira, the best-selling drug in the world, is set to retain its market dominance until at least 2023 even though the FDA recently approved a copycat, “biosimilar” version of the medicine from competitor Amgen. The two companies have reached a settlement that will keep the cheaper Amgen treatment off the market until January 31, 2023.
Zynerba shares soar on cannabis-based drug trial results. Zynerba Pharmaceuticals stock spiked 53% in Thursday trading after the company announced positive mid-stage clinical trial results for its experimental cannabis-based gel. The therapy, ZYN002, is being tested for reducing symptoms (like anxiety and other behavioral issues) associated with young children and teenagers who have the genetic autism spectrum disorder Fragile X syndrome.
THE BIG PICTURE
Health Secretary Tom Price under fire over chartered flights. Health and Human Services Secretary Tom Price is taking heat after a recent Politico report finding that he’s been using private chartered jets to get around the country on the taxpayer dime. “I was looking into it and I will look into it and I will tell you personally, I’m not happy about it,” President Trump told reporters Wednesday about the situation. “I am not happy about it and I let him know it.” Price says he still believes he ultimately has Trump’s confidence. (Fortune)
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|Produced by Sy Mukherjee|