Insulin Biosimilars Expected in 2024; Dexcom’s CGM for Hospital Use; Tymlos for Men?

The nonprofit drugmaker Civica announced plans to make three types of lower-cost insulin — biosimilars of Lantus, Humalog, and Novolog — which are expected to be available in the U.S. by 2024. (Reuters)

The FDA granted breakthrough device designation to Dexcom’s continuous glucose monitor (CGM) for use in a hospital setting, the company announced.

The Endocrine Society updated its policy for journal authors changing their names — designed to support transgender or nonbinary authors, as well as those who change their names due to marriage, divorce, religious conversion, or other reasons — allowing for name changing without a public announcement through a correction notice.

Radius Health submitted a supplemental new drug application to the FDA for the subcutaneous injectable abaloparatide (Tymlos), looking for an indication in men with osteoporosis at high risk for fracture. The supporting findings from the phase III ATOM study will be presented at this year’s American Association of Clinical Endocrinology (AACE) Annual Meeting.

Following the huge demand — and subsequent supply shortage — of the obesity drug Wegovy (semaglutide), maker Novo Nordisk has more than doubled its sales targets by 2025. (Reuters)

That being said, a new report from GlobalData predicted that Novo Nordisk will “successfully overcome the supply challenges surrounding Wegovy in the second half of 2022 and that the drug will likely become a blockbuster therapy for obesity from 2023.”

And in related news, the Institute for Clinical and Economic Review said it plans to compare the clinical efficacy and value of the following obesity treatments: subcutaneous semaglutide (Wegovy), phentermine/topiramate (Qsymia), liraglutide (Saxenda), and naltrexone/bupropion (Contrave).

Lipid profiling — also know as lipidomics — can help to pinpoint one’s risk for developing type 2 diabetes and cardiovascular disease. (PLOS Biology)