A federal court judge ruling leaves in place an FDA determination that shortages of the Novo Nordisk drugs Wegovy and Ozempic are resolved. Consequently, compounding pharmacies must stop making their versions of the metabolic medicines or face FDA enforcement action.
Novo Nordisk’s type 2 diabetes drug Ozempic has expanded its label to include chronic kidney disease. The new FDA approval comes as makers of GLP-1 drugs work to expand the uses of these products.
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The Novo Nordisk/Ascendis partnership’s lead program is once-monthly injectable semaglutide for type 2 diabetes and obesity. This product candidate will be developed with Ascendis Pharma technology that has already yielded two FDA-approved products with longer dosing intervals.
Novo Nordisk’s Wegovy achieved statistically significant improvement in a Phase 3 study in the fatty liver disease MASH. Based on these preliminary results, the company plans to seek U.S. and European Union approvals in this indication in 2025.
Blockbuster Novo Nordisk drug Ozempic now has clinical trial results showing statistically significant reductions in the risk of kidney disease progression. The company said these results support the expansion of the drug’s label to chronic kidney disease.
Zocdoc Founder and CEO Oliver Kharraz gave five predictions about how patient preferences will evolve in 2024. Some of them include Americans increasingly seeking cash-pay care options and an uptick in patients seeking mental health appointments before and after the presidential election.
Radiologists today face a surge in imaging volume and pressure to produce fast, accurate reports. Workflow optimization is about delivering the right results at the right time with less friction.
A study testing Novo Nordisk's semaglutide in chronic kidney disease is ending early after an interim analysis met efficacy goals. Detailed results are not yet available, but they could support expanding use of the GLP-1 agonist, which is far and away Novo Nordisk’s top-selling product.
Novo Nordisk weight-loss drug Wegovy reduced the risk of major cardiovascular events by 20% in a large clinical trial. The company said the results support expanding the drug’s label, but the looming question is whether the data will persuade payers to cover the pricey chronic therapy.
Novo Nordisk can afford the price cuts prices to several branded and non-branded insulins. Flattening revenue for the pharmaceutical giant’s insulin products is offset by demand for diabetes and obesity drugs from its semaglutide franchise, which continues to grow by leaps and bounds.
The drug, Rybelsus, is the first oral medication in the GLP-1 receptor agonist class. The approval was based on data from 10 trials that enrolled more than 9,500 patients.
To ensure effective cost mitigation, employers can’t wait for the market to adjust — they have to punch first.