Insulet Issues a Nationwide Voluntary Medical Device Correction for the Omnipod 5 Controller
Insulet Corporation announced a Medical Device Correction for the Omnipod 5 Automated Insulin Delivery System because of an issue with the Omnipod 5 Controller charging port and cable. This does not impact the Omnipod 5 Pod, the Omnipod DASH Insulin Management System, the Omnipod Insulin Management System, or compatible Android smartphone devices that have the Omnipod 5 App installed. These actions are taken voluntarily with the knowledge of the FDA.
Insulet has received 24 reports that the Omnipod 5 Controller charging port (USB-C port) or cable (USB cable) are melting, deforming or discoloring due to heat generated by a poor connection between the cable and the port. The excess heat may cause minor burns if those areas of the Controller are touched or could lead to fire. No serious injuries have been reported to Insulet as a result of this issue.
First-of-its-kind Type 1 diabetes drug wins FDA approval was reported by Delilah Alvarado for BioPharmaDive.com, 18 November 2022.
One year after an initial regulatory rejection, Provention Bio’s injectable drug teplizumab has won Food and Drug Administration approval for preventive treatment of Type 1 diabetes. The drug, which will be sold under the name Tzield, is the first treatment cleared by the FDA to delay the onset of Type 1 diabetes. It is approved for individuals over the age of 8 who are considered to be in stage 2 of the autoimmune disease. The agency based its approval on data from a study in 2019 that showed patients with stage 2 Type 1 diabetes who received Tzield went longer before receiving a stage 3 diagnosis than those given placebo.
Originally developed by MacroGenics, Tzield is an antibody that targets a protein known as CD3 in order to regulate the immune system. The drug has been in testing for years, passing from MacroGenics’ hands to Eli Lilly in 2007, then back to MacroGenics again after a Phase 3 study failure in 2010.
In 2018, the New Jersey biotechnology company Provention acquired rights to the drug and has been faithfully betting on the drug’s promise to prevent the full onset of Type 1 diabetes. Provention in October entered a marketing agreement with Sanofi. Teplizumab will be sold at a price of $13,850 a vial, with a 14-vial regimen costing $193,900 at list price.
FDA approves Rezvoglar as second ‘interchangeable’ insulin biosimilar was written by Christopher Newman for BioPharmaDive.com, 18 November 2022.
The Food and Drug Administration has approved Eli Lilly’s long-acting insulin Rezvoglar as an “interchangeable” product with Sanofi’s Lantus, making it the second insulin biosimilar to receive the valuable designation. The approval comes a year and a half after Viatris and Biocon’s Semglee became the first insulin biosimilar to receive interchangeable status, securing 12 months of exclusivity before the FDA could add the tag to another copycat competitor.
There are several long-acting insulins available on the market, and the availability of Semglee and Rezvoglar now gives patients and providers further choice. The added competition could act as another lever for insurers to control insulin costs in the U.S., which have drawn the criticism of lawmakers and the public for years.
Sugar Alcohols Are in Many Sugar-Free Foods. What Are They? was reported by Hannah Seo for NYTimes.com, 15 November 2022.
If you are a regular reader of food packaging, you may have noticed a row under the “total carbohydrate” section of some nutrition facts labels called “sugar alcohol” — and wondered what it means. Despite what the name might imply, sugar alcohols are neither sugars nor alcohols, said Imashi Fernando, a registered dietitian nutritionist in Seattle. They are a type of carbohydrate that can be added to foods and drinks to make them sweeter without adding the same amounts of calories and carbs as regular sugar. They are not technically artificial sweeteners, Ms. Fernando said.
Some sugar alcohols can be found in whole foods. Pineapples, olives, asparagus, sweet potatoes and carrots are natural sources of mannitol; cereals, mushrooms and some fruits and vegetables contain xylitol; and various fruits like apples, pears, blackberries, peaches and prunes contain sorbitol.
But the sugar alcohols often present in packaged products — like sugar-free candies, gums, chocolate, energy bars, cookies, energy drinks, cough syrups, throat lozenges and toothpastes — are synthetically produced. You can usually spot many sugar alcohols on ingredients lists by the “-ol” at the ends of their names.
The main draw of sugar alcohols is that they can sweeten foods and drinks without adding too many calories and carbohydrates, said Joanne Slavin, a professor of food science and nutrition at the University of Minnesota. Whereas regular table sugar supplies about four calories per gram, Dr. Slavin said, sugar alcohols provide much less than that — “anywhere from half a calorie to three calories per gram.”
They also help keep carbohydrate intake low because they are not completely absorbed through digestion, Ms. Fernando said.
Many of the downsides of sugar alcohols have to do with how they are processed in the gut. Regular sugars are broken down during digestion and then absorbed in the small intestine, said Dr. William Chey, a gastroenterologist and professor of medicine at Michigan Medicine. Sugar alcohols, on the other hand, are “very slowly and incompletely broken down in the small intestine,” he said. The small portion that is broken down gets absorbed as usual, he added — but the half to two-thirds of sugar alcohols that remain unabsorbed move on to the large intestine where they feed your gut bacteria. Bacteria consequently produce gases and short-chain fatty acids, which pull water into your colon and create a laxative effect. Consuming a lot of sugar alcohols, Dr. Chey said, can lead to flatulence, bloating, abdominal pain and diarrhea, especially if you have “underlying gastrointestinal conditions like irritable bowel syndrome or inflammatory bowel disease,” he added.
What are the health benefits of stevia? Is it safe? was posted by Tod Cooperman, M.D., for ConsumerLab.com, 10 November 2022.
Many stevia extract products contain added bulking ingredients (which also have a sweet taste), so be sure to read labels carefully to know exactly what you are getting:
- Truvia (Cargill), Sweet Additions Stevia packets (from Aldi stores), and Great Value Stevia packets (from Walmart) contain erythritol, a sugar alcohol that is considered “zero-calorie.” In 2014, Cargill settled two lawsuits that charged the company with misleadingly promoting Truvia as a “natural” sweetener primarily derived from stevia, when it actually contains a significant amount of erythritol.
- Packets of stevia extract from Stevia in the Raw (Cumberland Packing Corp.) and PureVia (Pepsico and Whole Earth Sweetener Company) contain dextrose (a simple sugar). Stevia in the Raw’s website notes: “In our packet product, dextrose is used to dilute the very potent stevia leaf extract to make it measurable for consumers; dextrose does not alter the sweet flavor of the Stevia.”
- Other ingredients that have been added to stevia products include maltodextrin (in some Great Value and Sweet Additions stevia products), xylitol, and inulin.
BetterStevia Organic Extract Powder by NOW Foods, which contains no fillers and uses stevia whole leaf extract (rather than isolated constituents) to reduce the bitterness costs slightly less than other stevia products without fillers — about $3.77 per ounce. Based on its slightly lower price compared to other stevia extracts without fillers and its reduced bitterness, BetterStevia Organic Extract Powder is our Top Pick for stevia for use as a sweetener.
Veggies taste better with rock music—here’s why was posted by FastCompany.com, 18 November 2022.
Wholly Veggie injects fun and absurdity into its latest ad campaign with heavy metal, trickery, and vegetables. It’s a must-watch. This is Fast Company’s Brand Hit or Miss of the week.