Oncobesity News Posts

Off-Label GLP-1 Use Skyrockets in Young Kids

Off-Label GLP-1 Use Skyrockets in Young Kids

(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…

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

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.

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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.

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GLP-1 RAs produce significant weight loss in adults without diabetes, with newer treatments showing greater results

Wednesday, September 2 – An updated systematic review evaluating the efficacy and safety of glucagon-like peptide-1 receptor agonists (GLP-1 RAs) and coagonists among adults with overweight or obesity without diabetes found that, among currently available treatments, tirzepatide produced the greatest weight loss, while newer experimental drugs showed even larger effects.

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GLP-1s do not cause major psychiatric harm, according to new study

Tuesday, September 1 – There is no link between the widely used diabetes and obesity medications known as GLP-1 receptor agonists and increased suicidal thoughts, depression or other serious psychiatric harm, based on an integrative review of current scientific evidence conducted by researchers at New Mexico State University and the University of Nevada, Las Vegas.

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GLP-1 Drugs Tied to Gallbladder and Biliary Risks in Youth

Tuesday, September 1 – (MedPage Today) — Use of GLP-1 receptor agonists was associated with increased cumulative gallbladder and biliary events in youths, according to a retrospective analysis of TriNetX data.
Among over 37,000 adolescents and young adults with overweight…

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Court: No harm done when GLP-1s dropped from FDA shortage list

Tuesday, September 1 – Since the Federal Food, Drug and Cosmetics Act requires the U.S. FDA to maintain an updated list of prescription drugs that are in shortage, does the FDA have to go through months of a notice-and-comment rulemaking before it can remove a drug from the list when the agency determines it’s no longer in short supply? The U.S. Court of Appeals for the Fifth Circuit danced around that question even as it upheld a lower court’s summary judgment shutting down compounders’ challenges to the FDA removing Eli Lilly and Co.’s and Novo Nordisk A/S’ popular GLP-1 drugs from the shortage list in October 2024.

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About a Quarter of Those Who Stop Wegovy Start Again

Saturday, August 29 – (MedPage Today) — Nearly half of adults who started semaglutide (Wegovy) for obesity management stopped treatment within a year, a Danish cohort study showed.
Among 157,822 first-time semaglutide initiators without diabetes, 49% discontinued…

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5th Circ. Backs FDA, Pharma Cos. In GLP-1 Shortage Fight

Saturday, August 29 – The U.S. Food and Drug Administration did not unlawfully remove blockbuster GLP-1 medications made by Eli Lilly & Co. and Novo Nordisk from the national drug shortage list, the Fifth Circuit ruled Thursday, handing a loss to compounding pharmacies that produce copycat doses of the drugs.

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Fighting childhood obesity: Researchers study semaglutide with adolescents

Saturday, August 29 – Kentucky has one of the highest childhood obesity rates in the country, and the health consequences carry forward throughout life. That’s one of the reasons researchers at the University of Kentucky are leading a groundbreaking clinical trial to determine whether medical intervention can reverse the early signs of heart disease in children struggling with severe obesity.

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GLP-1 meds prompt rethink of obesity and eating disorder care

Saturday, August 29 – Obesity and eating disorders have traditionally been treated as separate areas of health care—but the rapid rise of GLP-1 medicines is increasingly bringing the two together. Adelaide University researchers say the growing use of medicines such as Ozempic and Mounjaro is highlighting an underrecognized overlap between the conditions—and raising important questions about who could benefit and who may be at risk.

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Pharmacy Asks Court To Toss Novo Nordisk Semaglutide Suit

Wednesday, August 26 – A pharmacy asked a Texas federal judge to toss claims brought by Novo Nordisk Inc. accusing the pharmacy of illicitly compounding a lucrative weight-loss drug called semaglutide, saying Novo Nordisk’s complaint amounts to a grievance list against the compounding industry.

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People’s bodies are changing in the age of Ozempic. How are we meant to talk about it?

Wednesday, August 26 – Discussing people’s bodies can be fraught. We asked eating disorder experts how to do so – or not – responsiblyIn the age of Ozempic and people being open about plastic surgery, discussion about people’s bodies is rife. At the same time, nobody seems quite sure how to talk about them, as shown by recent coverage of celebrities like Ariana Grande.It is a fraught topic. We asked eating disorder experts for guidelines to follow when talking about other people’s bodies, and how to do so without doing harm. Continue reading…

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Smart probiotics can sense high blood sugar and release GLP-1 on demand

Monday, August 24 – For people living with diabetes, managing blood sugar can mean constantly watching the clock, keeping meals and medications on schedule and staying alert to changes in glucose levels. While little can be done about timed meals, researchers have developed a biological system that detects rising blood sugar levels and automatically responds by releasing medication to bring glucose back down.

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