The European Medicines Agency is set to review several diabetes and weight-loss treatments this week in connection with potential increased risk of suicidal ideation and self-harm, according to a draft agenda document of the agency’s Pharmacovigilance Risk Assessment Committee.
Tag Archive for: European Medicines Agency
The European Union’s medicines regulator has delayed it decision on Eisai and partner Biogen’s Alzheimer’s disease drug that was expected this week, the Japanese company said today.
A week after Britain’s debut of the four-week Kwikpen, a European Medicines Agency panel is slated to review Eli Lilly’s multi-dose, pre-filled pen injector for diabetes drug Mounjaro.
The EU’s drug regulator was still reviewing on Friday whether Novo Nordisk’s popular weight-loss drug Wegovy could also be used in some cases to reduce the risk of strokes and heart attacks.
The healthcare industry is acutely aware of the elevated compliance concerns involved with artificial intelligence and machine learning, and its governing organizations are taking swift action to address these challenges. In fact, the latest guidelines proposed by international regulatory organizations such as the FDA, European Union (EU), and European Medicines Agency (EMA) are poised to reshape the lifesciences industry, especially for clinical trials.
For this study, published online in the journal Nature and funded by the U.S. National Institutes of Health, researchers reviewed data on 240,258 U.S. patients prescribed Wegovy or other medications for weight loss and nearly 1.6 million with type 2 diabetes prescribed Ozempic or other treatments.
The European health regulator cited recent data that did not confirm the blood cancer drug’s effectiveness.
Sanofi’s Fexinidazole Winthrop is the first oral treatment for an acute form of sleeping sickness, a lethal parasitic disease transmitted by the bite of infected tsetse flies and found in 36 African countries.
The move follows a review that started in July and covered a range of drugs known as GLP-1 receptor agonists, also including Eli Lilly’s Trulicity, Sanofi’s Suliqua, AstraZeneca’s Bydureon and Novo’s Rybelsus and Saxenda.
The company said that the marketing authorization decision could come early next year.
