Off-Label GLP-1 Use Skyrockets in Young Kids

Saturday, September 5 – (MedPage Today) — Prescribing GLP-1 receptor agonists to children ages 8 to 11 years with obesity surged 310-fold since 2019, despite a lack of FDA approval in kids under 12, a large cross-sectional analysis showed.
Among over 3.5 million children…

GLP-1 Scripts Rising Faster Among Adults With Serious Mental Illness

Saturday, September 5 – (MedPage Today) — Adults with serious mental illness (SMI) received GLP-1 drug prescriptions at higher rates than those without SMI from 2018 to 2024, an analysis of U.S. insurance claims data showed.
Among people with an underlying GLP-1-indicating…

Regulatory: Nods for Mounjaro in lowering CV risk, Bixlenvo and Tivicay in HIV

Saturday, September 5 – Regulatory snapshots for biopharma and med tech, including global submissions and approvals, and other regulatory decisions and designations: Abbott, Abbvie, Alvotech, Astrazeneca, Beyond, Biogen, Biontech, Bonesupport, Cortec, Cytomx, Daiichi Sankyo, Eisai, Eli Lilly, GE, Gilead, Hamamatsu, Highlife, Hutchmed, Juniper, Karyopharm, Kowa, Moderna, Nicox, Novavax, Palvella, Pfizer, Pharmassentia, Pixcell, Priovant, Revolution, Roche, Ropca, Scholar Rock, SL, Takeda, T-Maximum, Uniqure, United, Vara, Viiv, Xentria, Zambon.

FDA Approves Mounjaro for Cardiovascular Risk Reduction in Type 2 Diabetes

Thursday, September 3 – The FDA has approved Mounjaro for cardiovascular risk reduction in people with type 2 diabetes. Milko · E+/Getty

The FDA has approved Mounjaro to help reduce the risk of major cardiovascular events in people with type 2 diabetes who are at high risk.

A major clinical trial found that Mounjaro performed as well as Trulicity for reducing the risk of heart attack, stroke, and cardiovascular death.