By Tristan Manalac Pictured: Novo Nordisk signage outside its office in California/iStock, Sundry Photography Novo Nordisk on Friday announced that it is investing more than $6 billion to boost manufacturing capacity in its home country of Denmark to meet current and future demand for products targeting serious chronic diseases. The Danish company will start rolling out the investment this year, with an initial $3.6 billion capital tranche and will continue to invest over the next six years. The additional funding will be channeled into facilities in Denmark, where the pharma giant currently has more than 23,000 employees—most of whom work at production sites. The multibillion-dollar manufacturing boost comes as Novo is struggling to keep up with the staggering demand for its weight-loss medication Wegovy (semaglutide). Manufacturing issues have also hounded the GLP-1 agonist, forcing the company to restrict the U.S. supply of the lower doses of the therapy. Novo will ...
Eli Lilly weight management drug Zepbound landed its much anticipated FDA approval. The new Lilly product is in the same drug class as Novo Nordisk weight medication Wegovy, but it offers an additional mechanism of action and costs less. By FRANK VINLUAN A blockbuster Eli Lilly drug for type 2 diabetes now has an additional FDA approval in chronic weight management, a regulatory decision that positions the pharmaceutical giant to more directly compete in cardiometabolic conditions against a Novo Nordisk molecule that has become a sales juggernaut in its own right. Lilly’s new drug is the same as its type 2 medication Mounjaro, but it will be marketed under the brand name Zepbound. The Indianapolis-based drugmaker expects Zepbound will become available in the U.S. by the end of this year. The FDA approved Zepbound as a way to help patients lose weight and keep it off. The Wednesday regulatory decision ...
An apparent win for Novo Nordisk’s GLP-1 blockbuster Ozempic in chronic kidney disease (CKD) could herald a shift in how the condition has been treated for decades. But dialysis bigwig DaVita—whose future business could be on the line—is making its skepticism known. Based on the inclusion criteria for CKD patients in Novo Nordisk’s FLOW trial, which stopped early this week after hitting pre-specified criteria for efficacy, DaVita believes there may only be “limited application” of the findings to the overall CKD population. DaVita, which shares a significant chunk of the dialysis industry with its German rival Fresenius, admitted it’s “nearly impossible” to draw any conclusions from Novo’s study at this point, given that the detailed results are still under wraps. Emboldened by Ozempic’s performance thus far, Novo on Wednesday said it would begin powering down FLOW on the advice of the study’s independent data monitoring committee. The company expects the ...
By Tristan Manalac Novo Nordisk is ending its Phase III FLOW trial ahead of schedule after an interim analysis of the kidney outcomes study of semaglutide found a very high likelihood of study success, the company announced Tuesday. FLOW, a large randomized, double-blinded and placebo-controlled superiority trial, was assessing the effects of Novo’s GLP-1 agonist semaglutide on the progression of renal impairment and on the risk of renal and cardiovascular mortality in patients with type 2 diabetes and chronic kidney disease (CKD). Semaglutide is the active ingredient in Novo’s diabetes drug Ozempic and weight-loss treatment Wegovy, approved in January 2020 and June 2021, respectively. The study enrolled more than 3,500 patients worldwide and administered semaglutide as an adjunct to standard of care. FLOW’s protocol allowed for an interim analysis once a specific and pre-determined number of primary endpoint events had already occurred. At this interim analysis, an independent Data Monitoring ...
By Kate Goodwin Novo Nordisk has again bought a weight-loss focused biotech, as the obesity market heats up. Announced Wednesday, the Danish pharma plans to buy Embark Biotech for $16.3 million up front with close to $500 million on the line in milestone payments—Novo’s second obesity-focused acquisition in three weeks. Novo participated in the seed round for Embark in 2017 when the biotech spun out from Novo Nordisk Foundation Center for Basic Metabolic Research at the University of Copenhagen. The company said it was founded on the discovery of a “novel target that suppresses appetite increases energy expenditure and enhances insulin sensitivity.” The acquisition announced Wednesday gives Novo full rights to develop and commercialize Embark Biotech’s lead metabolic program, currently in preclinical stages. Included is a three-year R&D collaboration with Embark Laboratories, a new company being formed by the biotech’s team to develop therapies for obesity and related conditions, with ...
By Tristan Manalac Novo Nordisk’s weight-loss medication Wegovy (semaglutide) met its primary efficacy endpoint in the Phase III SELECT trial, demonstrating strong protective effect on cardiovascular health in overweight and obese adults without diabetes, the company announced Tuesday. At a 2.4-mg dose level, once-weekly Wegovy injections significantly reduced the occurrence of major adverse cardiovascular events (MACE) by 20% as compared with placebo. This treatment effect was statistically significant, according to Novo’s announcement. Wegovy’s safety profile in SELECT was also in line with what had been established in previous studies. SELECT defined MACE as a composite of cardiovascular death, non-fatal myocardial infarction or non-fatal stroke. Wegovy reduced the frequency of all three MACE components in SELECT. Novo was trading approximately 11% higher in pre-market Tuesday following the data drop. The results from SELECT highlight the potential dual benefits of Wegovy for overweight and obese adults who suffer from a heightened risk ...
The European Medicines Agency has identified risks of self-harm and suicidal ideation that could potentially be linked to Novo Nordisk’s medications containing the active ingredients semaglutide and liraglutide. The potential risks were first identified by the Icelandic Medicines Agency, according to a CNN report, citing the EMA. Iceland’s regulator documented one case of suicidal ideation in a patient who had taken the diabetes drug Ozempic (semaglutide) and another after using the weight-loss medicine Saxenda (liraglutide). A third incident involving thoughts of self-harm was also detected in a patient who was receiving Saxenda. The Pharmacovigilance Risk Assessment Committee (PRAC), the EMA’s main group responsible for assessing and monitoring the safety of drug products, has put both treatments under review. The committee is also evaluating whether it will need to extend the review to other products in this drug class, according to CNN. This class, called GLP-1 receptor agonists, include Novo’s Wegovy, Victoza, and Rybelsus, as well as ...
Kyle LaHucik May Associate Editor A few months after the FDA approved the weight loss drug Wegovy for adolescents, researchers are out with a post-hoc look at the late-stage data, this time finding that 45% of the teens taking Novo Nordisk’s drug dipped below the clinical cutoff for obesity. The analysis, presented by University of Minnesota pediatrics professor Aaron Kelly at this week’s European Congress on Obesity in Dublin, gives new insight into the popular drug, which is part of the ballooning obesity R&D field that has Novo and Eli Lilly in the lead and biopharmas like Amgen and Boehringer Ingelheim racing to catch up. The results from the same study, the STEP TEENS trial, were published in the New England Journal of Medicine last December, shortly before the FDA expanded the original 2021 label for adults to include teens 12 years old and older. Almost three-quarters (74%) of teens ...
Novo Nordisk has moved into sickle cell disease through a licensing deal (PDF) with EpiDestiny. The $400 million deal gives Novo worldwide rights to an epigenetic treatment of the disease that is closing in on the start of a phase 2 trial.
Antimicrobial resistance is a global threat to human health. Novo Holdings today announces the launch of an impact fund commissioned by the Novo Nordisk Foundation with a total budget of USD 165 million to invest in companies involved in discovering and early-stage development of therapies to combat antimicrobial resistance.
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