In the meantime, Dexcom (Nasdaq:DXCM) is getting ready, VP of Global Clinical Initiatives Tomas Walker said.
Walker recently spoke with Medical Design & Outsourcing to discuss the San Diego-based diabetes device developer’s proactive approach to chronic COVID-19 conditions, technology that can help diagnose new cases, and the likelihood that particular devices and components will be in greater demand in the years ahead.
Get the full story at our sister site, Medical Design & Outsourcing.
Dexcom VP of Global Clinical Initiatives Tomas Walker [Photo courtesy of Dexcom]
New data is showing that COVID-19 may increase a person’s risk of diabetes, but it could be years until we know for sure.In the meantime, Dexcom (Nasdaq:DXCM) is getting ready, VP of Global Clinical Initiatives Tomas Walker said.
Walker recently spoke with Medical Design & Outsourcing to discuss the San Diego-based diabetes device developer’s proactive approach to chronic COVID-19 conditions, technology that can help diagnose new cases, and the likelihood that particular devices and components will be in greater demand in the years ahead.
The following has been lightly edited for space and clarity.
MDO: How does the SARS-CoV-2 virus and its COVID-19 disease affect the pancreas?
Walker: In February, March of 2020, there were a couple of papers published out of China very early in the expe…
The researchers say the steps of estimating the carbohydrate content of a meal, drawing blood to measure blood glucose levels, then calculating the proper insulin dose before injecting the insulin — which typically must be repeated for every meal — make it difficult to maintain a treatment regimen. Those researchers say they’ve developed a new approach that makes the process easier and more efficient while helping diabetes patients maintain their healthy glucose levels.
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Walmart (NYSE:WMT) is launching what it describes as the first private label analog insulin. The company estimates the insulin products will save customers between 58% and 70% of the cost of branded insulin.
Novo Nordisk (NYSE:NVO) will manufacture the analog insulin, which is a type of lab-grown insulin genetically engineered to optimize glucose control. The retail price of analog insulin vials will be $72.88, while a FlexPen insulin pen will cost $85.88. Walmart has concluded that the per-unit savings of the products will be $101 per vial and $251 per insulin pen, respectively.
The insulin will only be available through Walmart’s ReliOn brand of diabetes products.
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Kaiser Permanente touts a study demonstrating that using continuous glucose monitors offers better blood sugar control for patients with type 2 diabetes.
Patients with insulin-treated type 2 diabetes using continuous glucose monitors (CGMs) typically had better blood sugar control and fewer visits to the emergency room for hypoglycemia, the study found. The study was published yesterday in JAMA and was supported by an independent investigator award from Dexcom and funding from the National Institute of Diabetes and Digestive and Kidney Diseases.
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The FDA today issued a draft guidance with recommendations for clinical trials for certain devices intended for treating diabetes.
Included in the guidance are recommendations for feasibility and early feasibility clinical studies for certain medical devices intended to therapeutically improve glycemic control in patients with type 2 diabetes mellitus, independent of medication delivery, according to a news release.
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Insulet (NSDQ:PODD) shares fell 4% today on break-even first-quarter results that were lower than analysts’ expectations. The company, however, raised the low end of its revenue guidance range to 16% to 20%. The range was previously 15–20%.
The Acton, Mass.-based wearable insulin delivery system developer posted a net loss of $0.0 million, or 0¢ per diluted share, on sales of $246.1 million for the three months ended March 31. For the sake of comparison, the company had a net loss of $2.1 million, or $(0.03) per diluted share, in the same quarter of 2020.
Adjusted to exclude one-time items, earnings per share were $0.00. Analysts were looking for EPS of $0.08 on sales of $247.1 million.
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Global pharma firm Novo Nordisk (NYSE:NVO) will launch a Phase 3a study to investigate the potential of oral Ozempic (semaglutide) to treat obesity.
The drug is currently indicated in a subcutaneous form in the U.S. for people with type 2 diabetes to improve glycemic control in conjunction with diet and exercise and to lower diabetics’ risk of major adverse cardiovascular events.
The most recent Phase 3a trial will test an oral 50-mg dose of the drug with roughly 1,000 volunteers who are obese or overweight with comorbidities.
The company anticipates that the 68-week study will kick off in the second half of 2021.
Recent clinical trial results indicate that subcutaneous semaglutide paired with behavioral therapy can support weight loss.
Novo Nordisk has also filed a new drug application with the FDA for a 2.4-mg dose of subcutaneous semaglutide for chronic weight management. The company is seeking a similar indication in the European m…
Two international clinical trials published today in Diabetes Care found that the once-weekly treatment has the potential to offer a convenient alternative to daily insulin shots for those with type 2 diabetes, according to a news release.
Get the full story at our sister site, Drug Delivery Business News.
Two international clinical trials published today in Diabetes Care found that the once-weekly treatment has the potential to offer a convenient alternative to daily insulin shots for those with type 2 diabetes, according to a news release.
Get the full story at our sister site, Drug Delivery Business News.
Novo Nordisk announced that the FDA issued a refusal-to-file letter related to its application to expand the label for once-weekly subcutaneous Ozempic (semaglutide).
The company had sought to expand the label for a 2.0-mg dose of once-weekly semaglutide to treat type 2 diabetes. It filed the letter on Jan. 20, 2021.
The letter indicates that FDA has concluded additional information is needed to review an application.
FDA requested information related to the new proposed manufacturing site for the drug.
Novo Nordisk stated that it believes it has sufficient data to warrant the label expansion application.
The company plans to resubmit the application to FDA in the second quarter of 2021.
The current FDA labeling recommends patients begin taking 0.25 mg of semaglutide once weekly, increasing to 0.5 mg after four weeks. Patients who require additional glycemic control can have the dose to 1 mg once weekly after an additional four weeks…
Vertex Pharmaceuticals announced today that FDA has granted fast track designation for its VX-880, an investigational human stem cell-derived islet cell therapy for type 1 diabetes.
Vertex has begun a clinical trial for VX-880 (formerly known as STx-02) in patients with type 1 diabetes (T1D) with severe hypoglycemia and impaired hypoglycemia awareness.
“Ours is the only approach that produces fully differentiated and fully functional insulin-secreting pancreatic islets. We are very pleased to have received FDA’s fast track designation, which facilitates the development and expedites the review of drugs that treat serious conditions and fill an unmet medical need. We continue to work with urgency to bring this innovative therapy to patients,” said Bastiano Sanna, EVP and chief of cell and genetic therapies at Vertex.
Dr. Camillo Ricordi, director of the Diabetes Research Institute (DRI) and the Cell Transplant Center at the University of Miami, said…