FreeStyle Libre 3 Sensor Class I Recall; Second OTC CGM Cleared; Weekly Insulin Win

The FDA designated Abbott’s recall of FreeStyle Libre 3 sensors as the most serious, class I type due to the risk for incorrect high glucose readings.

After parts of her large intestine died and needed to be removed, a patient is suing Novo Nordisk, claiming the label of semaglutide (Ozempic, Wegovy) didn’t adequately warn about serious side effects. (CBS News)

A denosumab biosimilar demonstrated comparable efficacy and safety to branded Prolia in a phase III study of women with postmenopausal osteoporosis. (Journal of Clinical Endocrinology & Metabolism)

Abbott launched an over-the-counter continuous glucose monitoring system, Lingo, for adults not on insulin — the second such device to hit the market.

In a phase I dose-finding study of people with overweight or obesity, the highest dose of investigational oral GLP1-1 receptor agonist TERN-601 yielded a 4.9% placebo-adjusted weight loss over 28 days, said developer Terns Pharmaceuticals.

Modular Medical said the FDA cleared its MODD1 insulin patch pump for all adults with type 1 and 2 diabetes.

The agency also cleared Embecta’s disposable patch pump with a 300-unit insulin reservoir for people with type 2 diabetes.

Exposure to particulate matter with a diameter less than 2.5 µm was tied to infertility in Danish men ages 30 to 45. (BMJ)

Once-weekly insulin efsitora alfa had non-inferior HbA1c reduction compared with daily insulin glargine or insulin degludec (Tresiba) over 52 weeks in adults with type 2 diabetes, according to the QWINT-1 and -3 trials, respectively. Developer Eli Lilly will release results from the QWINT-2 and -5 trials at this week’s European Association for the Study of Diabetes (EASD) annual meeting.

Here’s how to spot fake Ozempic. (Reuters)

Some patients with obesity aren’t receiving necessary joint replacements when doctors say the procedures are too risky due to their weight. (New York Times)

SGLT2 inhibitors added to standard-of-care for 30 days didn’t increase days free of organ support or reduce mortality in adults hospitalized with COVID-19, the ACTIV-4a trial found. (Lancet Diabetes & Endocrinology)

Nonsteroidal anti-inflammatory drugs (NSAIDs) were the most effective for managing pain in acute osteoporotic vertebral compression fractures, a 20-trial meta-analysis found. (JAMA Network Open)

Women exposed to higher levels of certain per- and polyfluoroalkyl substances (PFAS) early in pregnancy had higher risks for adiposity around age 51. (Journal of Clinical Endocrinology & Metabolism)

Britain’s healthcare regulator cleared GLP-1 agents of being linked with suicidal thoughts, in line with conclusions from a European regulatory review and preliminary findings from the FDA.

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