Type 2 Diabetes

FDA approval means that pharmacists can swap biosimilar Semglee, an insulin product, for brand-name Lantus, although state-level pharmacy rules may apply.

The approval allows for substitution at the pharmacy counter for Lantus, its reference product.

Keytruda gets a full approval in endometrial cancer; while Xeljanz will miss another PDUFDA date.

New vaccine for pneumococcal disease, an sNDA approved based on real-world data, a new therapy for skin and muscle disease, Keytruda combination receives full approval in endometrial cancer, a new diabetes therapy is approved, and another JAK inhibitor misses PDUFA date round out this week’s FDA news.

FDA staff raised safety concerns ahead of the advisory panel hearing.

Keytruda loses one indication but gains another, Biogen narrows use of Aduhelm, Padcev gets regular approval and expanded indication, Amgen submits application for asthma biologic, agency issues complete response letter for diabetes prevention therapy teplizumab, Novartis resubmits NDA for inclisiran.

Study published in the Annals of Internal Medicine elaborates on past positive findings for Zynquista (sotagliflozin), a dual inhibitor of SGLT1 and SGLT2.

A longstanding four times per day testing requirement will cease, and patients using inhaled insulin now qualify for continuous glucose monitoring.

Semaglutide injection is a weekly injection for chronic weight management in adults.

Harvard researchers say, well, maybe.

The AstraZeneca drug is the first SGLT2 inhibitor approved for chronic kidney disease regardless of whether the patient has diabetes.

Dr. Kathleen Bethin, clinical professor, and Dr. Lucy Mastrandrea, associate professor and division chief of endocrinology/diabetes both at the Jacobs School of Medicine & Biomedical Sciences at the University at Buffalo, spoke with Vic Baldry of Cecelia Health to discuss the challenges telehealth has created when caring for families with children who have type 1 diabetes.

Access to care and other health disparities result in the low use of novel therapies for Black, female and lower income type 2 diabetes patients. If these barriers aren't addressed, disparities among kidney and cardiovascular patients may worsen in the U.S.

Application to the FDA is based on results from a placebo-controlled trial showing a 15% decrease in body weight among those who are obese or overweight.

Diabetes education has shifted from in-person classes to Zoom meetings.

Commercial health insurance plan enrollees are more likely to take glucose-lowering medications.

The findings are encouraging for future use of remote digital monitoring.

AstraZeneca’s leading diabetes medication could be approved to treat chronic kidney disease for patients with and without type 2 diabetes.

Digital health apps offer solutions to improve diabetes self-management.

Dr. Anthony Fauci addresses the American Heart Association Scientific Sessions.

After an FDA denial and a lost sponsor, sotagliflozin shows it can cut cardiovascular events and possibly treat a form of heart failure that has no approved therapies.

The findings are the first in a series of six studies involving a registry supported by drug makers in the diabetes, cardiovascular, and heart failure space.

Flu increases the risk of heart attack, especially among people with diabetes and atherosclerotic cardiovascular disease (ASCVD). COVID-19 and the possibility of co-infection makes getting vaccinated against the flu particularly important this year.

Three healthcare organizations provide models for managing the disease and keeping a close eye on the bottom line.