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.
Novo Nordisk’s diabetes drug Victoza is now approved in Europe as the only GLP-1 analogue with a label including prevention of cardiovascular events.
Denmark-based, Novo Nordisk developed a drug that stimulates insulin productions called semaglutide a class of drugs which categorized in GLP-1s. The new oral diabetes medicine is a better lowering blood sugar levels compared to the existing drug.
Sanofi will launch public offers to acquire all shares, including ADSs, warrants and convertible bonds of Ablynx. News of the deal will no doubt come as a great disappointment to Novo Nordisk, which recently stepped up its efforts to buy Ablynx with a second offer valued at around 2.6 billion euros.
Novo Nordisk announced that the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) of the US Food and Drug Administration (FDA) voted 16-0 in favour of the approval of once-weekly semaglutide to improve glycaemic control in adults with type 2 diabetes. One member of the committee abstained.
Regeneron is a role model for the biotech community. No biotech company wants to be Regeneron. “Becoming China’s Regeneron” is the slogan of many domestic biotechs. However, such a Regeneron cannot escape its midlife crisis. The attack of opponents, the victory of Eylea generic drugs, and the successive blows of dual-antibodies have put Regeneron in an extremely delicate stage. On the one hand, with two blockbuster drugs, Regeneron has completed the transformation from biotech to big pharma. In the first half of the year, its stock price continued to rise, successfully breaking through the $100 billion threshold, and its market value reached $133.2 billion. On the other hand, although the market believes in Regeneron’s R&D and platform technology capabilities, how can a new billion-dollar blockbuster drug be so easy? And Regeneron’s highly anticipated oncology business is not as glamorous as autoimmunity and ophthalmology, and its progress is also lackluster. So ...
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