Fully-implantable CGM receives FDA authorization for integration with insulin pumps by Jill Rollet for Healio.com/endocrinology, 30 April 2024.

The Eversense E3 CGM (Senseonics Holdings and Ascensia Diabetes Care) received authorization to be marketed as an integrated CGM through the FDA’s De Novo pathway. The device is the first fully implantable option in the category. The FDA authorization establishes special controls that serve as a predicate device for 510(k) submissions for future implantable devices.

The Eversense CGM consists of a small sensor inserted completely under the skin. The sensor communicates with a smart transmitter worn over the sensor. Data are uploaded every 5 minutes to a mobile app on the user’s smartphone. The CGM is indicated for use for up to 180 days among adults aged 18 years and older with diabetes.

Eversense’s new marketing authorization will allow it to be integrated with compatible medical devices, including insulin pumps that are part of an automated insulin delivery system. According to the press release, Senseonics plans to engage in partnership discussions with insulin pump manufacturers.  

Read more:  Fully-implantable CGM receives FDA authorization for integration with insulin pumps

Walmart Health shuts down by Rebecca Pifer for HealthCareDive.com, 30 April 2024.

Walmart is closing its network of health clinics after failing to make them profitable, in a major setback for the retail giant’s push into healthcare. Walmart Health launched as a one-store pilot in Georgia in 2019, and has since grown to 51 centers in five states, along with a virtual care offering. Yet the network has shown recent signs of trouble: Earlier this month, Walmart decelerated its expansion plans for the centers, which offer inexpensive, fixed-cost medical services like primary and dental care.

Walmart is now closing the clinics entirely due to a challenging reimbursement environment and escalating operating costs resulting in a lack of profitability.  “Through our experience managing our centers and virtual care offering, we’ve determined this is not a sustainable business model for us,” a Walmart spokesperson said. It’s a strategic turnaround for Walmart, which has invested heavily in expanding the network and even explored acquiring provider practices to bolster its primary care capabilities.

Read more: Walmart Health shuts down

Lilly counts on manufacturing scale-up to unstick obesity drug supply by Jonathan Gardner for BioPharmaDive.com, 30 April 2024.

Eli Lilly expects that, by the second half of this year, it will be able to manufacture at least 50% more sellable doses of the main ingredient in its GLP-1 medicines Zepbound and Mounjaro than it could during the same period last year.  The push to bolster the production capacity for the drugs, respectively sold for obesity and diabetes, is “the most ambitious expansion plan in our company’s history,” CEO David Ricks said.

Read more: Lilly counts on manufacturing scale-up for obesity drug supply

Novo Nordisk says prices dropping for Wegovy, Ozempic by Val Brickates Kennedy for SeekingAlpha.com, 2 May 2024.

The prices of Novo Nordisk’s popular GLP-1 drugs Wegovy and Ozempic reportedly fell during the first quarter due to higher volumes and increased competition, with the company expecting further price reductions this year.  Novo Nordisk CFO Karsten Munk Knudsen

Read more: Novo Nordisk says prices dropping for Wegovy, Ozempic

CVS slashes 2024 outlook — again — as Medicare seniors drive spending by Rebecca Pifer for HealthCareDive.com, 1 May 2024.

CVS had a significantly worse first quarter than the healthcare giant — or Wall Street — expected, after its insurance arm failed to adequately prepare for seniors’ high use of medical care, especially in inpatient facilities. The Rhode Island-based company’s health services segment — usually a reliable driver of growth — also saw its revenue and income fall in the quarter as its pharmacy benefit manager adjusted to the loss of a major contract with insurer Centene.

CVS slashed its earnings expectations for 2024 following the results. It’s the second time the company has lowered financial expectations this calendar year. “Clearly this is a disappointing result for us,” CFO Tom Cowhey said on a Wednesday call with investors, after which CVS’ stock fell more than 19%.

Read more: CVS slashes 2024 outlook again as Medicare seniors drive spending

Artificial sweetener neotame may have potential to damage gut, lead to IBS by Robby Berman for MedicalNewsToday.com, 29 April 2024.

Neotame, an artificial sweetener available for use in food products for which aspartame is inappropriate, may damage the intestine, according to a new study from Anglia Ruskin University in Cambridge, U.K.  The study finds that neotame can alter healthy cells in human intestinal walls. This can impact the integrity of the gut wall, potentially leading to irritable bowel syndrome and sepsis.  The U.S. Food and Drug Administration approved neotame for human consumption in 2002.  It is approved in many countries as a flavor enhancer and sweetener in cakes and other confectionary foods. It is also found in some sugar-free gums, lozenges, and beverages. Neotame may be introduced into foods in manufacturing or as a tabletop seasoning.  Neotame is 7,000 to 13,000 times sweeter than sucrose.

The study says the sweetener can directly damage epithelial cells in the intestinal wall as well as adversely affect bacteria in the gut.  The study was conducted in vivo with E. Coli (Escherichia coli) and E. faecalis (Enterococcus faecalis), in which researchers observed various pathogenic responses after exposure to neotame.  Among these was the production of biofilm, and an increase in the ability of damaged bacteria to cling to the intestinal walls.  The study is published in Frontiers in Nutrition.

“Our studies indicate that neotame causes an increase in stress signaling in our human cells which reduces the amount of junctions that hold our cells together in a tight barrier,” said Havovi Chichger, PhD, BSC, associate professor in biomedical science at Anglia Ruskin University. She is co-author of the new study, along with Aparna Shil, PhD, AFHEA, of Jahangirnagar University in Bangladesh.  “This weakens the strength of the barrier, causing more leak of materials from the gut into our blood,” Chichger explained.

Read more:  Artificial sweetener neotame may have potential to damage gut

FTC Again Polices FDA’s Laziness With Improper Orange Book Listings by Scott Strumello for SStrumello.com (Scott’s Web Log), 30 April 2024.

On April 30, 2024, the U.S. Federal Trade Commission (FTC) struck pharma again (https://www.ftc.gov/news-events/news/press-releases/2024/04/ftc-expands-patent-listing-challenges-targeting-more-300-junk-listings-diabetes-weight-loss-asthma for more). This time, it was for several diabetes medicines’ improper FDA “Orange Book” patent listings. The FDA Orange Book has become a point of the pharmaceutical industry’s attempt to limit competition. The reason is that if a patent is listed in the Orange Book, any generics or biosimilar medicines are put on an automatic 30 month (2 1/2) year “stay” (hold) until FDA will even consider generic or biosimilar drug applications or approvals. But only patents on drugs or biologic medicines are legally permitted in the FDA Orange Book, yet the FDA entrusts the pharmaceutical industry to do the right thing by adhering to that.

As it turns out, some pharmaceutical companies including Novo Nordisk and Eli Lilly & Company were improperly listing patents on medical devices which are not legally permitted in the FDA Orange Book hoping to delay competition by two and a half years. If they were ever called out on the improper Orange Book listings, pharma companies could simply respond by saying the improper patent listings were inadvertently included. FDA lacks any enforcement mechanism for improper Orange Book listings. 

However, the April 30, 2024 FTC move hit Novo Nordisk particularly hard. See the FTC letter to Novo Nordisk (https://www.ftc.gov/system/files/ftc_gov/pdf/novo-nordisk-ozempic-saxenda-victoza-_4302024.pdf) for the complaint. One or two inadvertent listings might have been an error, but Novo Nordisk had improperly listed 36 patents on medical devices such as pen injector devices which the company should never have been listed in the Orange Book because devices are not drugs or biologic medicines. In particular, the improperly listed Orange Book patents happened to be for the company’s cash-cow, GLP-1 inhibitor medicines. Originally, GLP-1 inhibitors were approved as treatments for Type 2 diabetes. But in 2014, Novo Nordisk applied for (and received) an FDA “label extension” for its then-current GLP-1 inhibitor known generically as liraglutide which was branded as Victoza for Type 2 diabetes. Novo Nordisk branded the version sold to used as a weight-loss drug as “Saxenda”. It followed the exact same pattern with its newer, and slightly-improved GLP-1 inhibitor known generically as semaglutide (sold as Ozempic and Rybelsus for Type 2 diabetes, and under the brand name Wegovy for weight-loss. These are slightly improved over liraglutide (requiring less frequent dosage, and in smaller volumes, for example), but the improvements are not materially significant.

Anyway, by the FTC challenging the improper Orange Book listings for patents on pen injector devices via the FDA patent dispute process, that effectively opens the door to biosimilar competition sooner, rather than later. At this very, Biocon, Sandoz, Amphastar Pharmaceuticals and Lannett Company all have biosimilar versions of liraglutide. In fact, Sandoz (now a newly public company which was spun-off from Novartis) forecasts that liraglutide biosimilars (made by China’s Gan & Lee, the same company which will culture its biosimilar insulins for glargine, aspart and lispro) could generate 69% of the company’s new product revenues in 2024 if its forecasts are correct. Rival Biocon received approval from the UK Medicines and Healthcare Products Regulatory Agency (MHRA) to sell a copy of liraglutide in the UK in April 2024.

Curiously, while the FTC complaint also challenged one of Amphastar Pharmaceuticals’ Orange Book patent listings for the inhalable glucagon product branded as Baqsimi, those patents were listed in the FDA Orange Book by the former owner Eli Lilly & Company. Ironically, while Amphastar may lose patent protections it is not legally entitled to on Baqsimi, Amphastar Pharmaceuticals is poised to concurrently benefit from the FTC actions against Novo Nordisk’s improper Orange Book listings. Amphastar has a Biologics License Application (BLA) on file for liraglutide as well. 

Just thought you might like to see what’s going on, behind the news you read … many thanks to Scott Strumello!

Read more: FTC Again Polices FDA’s Laziness With Improper Orange Book Listings


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