Tag Archive for: semaglutide

U.S. drug regulators issued a report detailing quality control lapses at Novo Nordisk’s main factory in North America as early as May last year, according to the report obtained by Reuters via a Freedom of Information Act request.

Reuters was not immediately able to authenticate the report. Novo Nordisk declined to comment on the report, but said in an emailed statement that the site was “running and producing for the market”.

Novo Nordisk notched another win Friday as its mega blockbuster Wegovy (semaglutide) proved to also help patients with a common type of heart failure. The Danish pharma company announced results from a Phase III trial, published in The New England Journal of Medicine, adding to the drug’s growing list of benefits. 

The Medicines and Healthcare products Regulatory Agency said AstraZeneca’s GLP-1 drug for type 2 diabetes, called exenatide and marketed as Bydureon, was also included in the review.

The European Medicines Agency (EMA) is probing Novo Nordisk’s diabetes drug Ozempic and weight-loss treatment Saxenda after Iceland’s health regulator flagged three cases of patients on the drugs thinking about suicide or self-harm.

The European Medicines Agency recently flagged a safety signal related to GLP-1 receptor agonists and sent a list of questions to manufacturers including Novo Nordisk, Eli Lilly, Sanofi and AstraZeneca.

Novo Nordisk is the only company with FDA approval to sell semaglutide drugs. It said that the pharmacies are selling new drugs without FDA approval and claiming to compete with Novo Nordisk’s approved drugs, violating federal and state law.

Novo plans to seek U.S. and European regulatory approval of the high-dose pill later this year, but timing of a market launch is “to be determined,” according to Mico Guevarra, medical director at Novo Nordisk.

A thyroid cancer safety signal was raised by the EU’s drugs watchdog last month over several Novo Nordisk (NOVOb.CO) products including semaglutide, which is used in popular diabetes and obesity medicines Ozempic and Wegovy.

Wegovy maker Novo Nordisk on Tuesday said it had sued some medical spas and wellness clinics in the United States for selling products claiming to contain semaglutide, the key ingredient in its popular weight-loss and diabetes drugs.