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.
Positive preliminary results for Eli Lilly’s efsitora alfa continue to build the case for this once-weekly insulin in type 2 diabetes patients. Lilly is trying to catch up to Novo Nordisk’s once weekly insulin icodec, which is commercially available in several markets around the world but is not yet approved by the FDA.
Monica Vajani, Executive Director for mHUB’s MedTech Accelerator, discusses how mHUB is helping innovators transition healthcare towards value-based care.
The FDA rejected Novo Nordisk’s biologics license application for icodec, citing questions about the manufacturing process for this once weekly insulin as well as its use by type 1 diabetes patients. But there are several high-profile FDA approvals in our recap of recent regulatory news.
The Phase 3 results for ocedurenone come less than nine months after Novo Nordisk acquired the drug from KBP Biosciences. Novo Nordisk has stopped the clinical trial in uncontrolled hypertension and chronic kidney disease, but is evaluating potential applications of the small molecule in other indications.
Novo Nordisk’s focus on diabetes and obesity shape its business development work, but the company is also exploring other areas. Top Novo Nordisk M&A executive John McDonald discussed his company’s strategy during a session at the BIO conference in San Diego.
GLP-1 agonists are transforming the weight loss market. Experts weighed in on the changes they’re seeing, speaking in a panel discussion during the MedCity News INVEST Conference in Chicago.
Closing cancer health equity gaps require medical breakthroughs made possible by new funding approaches.
Novo Holdings’ $16.5 billion planned acquisition of Catalent is facing another delay. Just weeks after Novo decided to resubmit its application to the FTC, the agency is seeking more information about the deal. This move has triggered a second 30-day delay in the antitrust review process.
Novo Nordisk’s strategy to grow beyond metabolic diseases includes expanding into adjacent areas such as cardiovascular disease. Acquiring Cardior Pharmaceuticals adds a novel RNA-based therapy that is a potential heart failure treatment.
Novo Nordisk reported its weight loss pill amycretin led to greater weight loss measured at 12 weeks compared to clinical trial results for its blockbuster obesity drug Wegovy. But these results are from a small Phase 1 study and more testing is needed.
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.
PurpleLab® stands out from others in this sector by providing its data analytics services to several different groups of users across healthcare and pharma companies.
After Novo Holdings acquires Catalent, it will sell three of the contract manufacturing giant’s sites to Novo Nordisk. Those facilities already make Novo Nordisk’s GLP-1 drugs for metabolic conditions, and they will help the company meet projected demand for these products in years to come.
Insulin prices have long been a pain point for diabetics. The big three insulin manufacturers have cut prices across their product lineups, but potential competition from other biosimilar insulins is still in earlier stages of development.
The FDA has found no clear relationship between GLP-1 drugs, such as Ozempic and Mounjaro, and reports of suicidal thoughts or actions. But the agency added that it can’t definitively rule out the risk, and its review is ongoing.
Novo Nordisk's planned expansion will more than double the footprint of its France production site, bringing new capacity for manfacturing GLP-1 drugs for metabolic conditions. The location is already one of the company’s largest for making diabetes products.
The KBP Biosciences drug Novo Nordisk is acquiring has reached Phase 3 testing as a potential treatment for uncontrolled hypertension and advanced chronic kidney disease. It’s the latest in a string of business deals aimed at expanding the Novo Nordisk pipeline beyond diabetes.