Tag Archive for: European Medicines Agency (EMA)

The European Medicines Agency is investigating the potential impacts that Novo Holdings’ $16.5 billion acquisition of contract manufacturing giant Catalent will have on drug supply, according to reporting Wednesday by Reuters.

Europe’s medicines regulator said on Friday its human medicines committee had recommended Eli Lilly’s diabetes drug Mounjaro also be approved as a weight-loss treatment.

The European Medicines Agency’s safety committee, on Friday, recommended pregnant women not use topiramate-containing medicines to prevent migraine or manage their body weight as their newborns could have a higher risk of neurodevelopmental disorders.

The European Medicines Agency (EMA) said on Wednesday its human medicines committee (CHMP) recommended authorizing Pfizer’s updated COVID-19 vaccine targeting the dominant XBB.1.5 variant of Omicron.

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.

Amylyx Pharmaceuticals Inc. said on Tuesday that a European regulatory panel had taken a negative view on its amyotrophic lateral sclerosis (ALS) treatment, stalling the company’s plans on introducing its first commercial drug in the region.

Brussels on Wednesday published a long-awaited draft of its proposed overhaul of laws governing the European Union’s pharmaceuticals industry, setting up a tussle with drugmakers which warn they will invest and innovate elsewhere.

The European Medicines Agency (EMA) expects COVID vaccination campaigns to be conducted once a year, similar to the approach with flu inoculation, it said on Wednesday.

A European Medicines Agency (EMA) committee said on Friday it has started a review of decongestant medicines for cold and flu that contain the ingredient pseudoephedrine following safety concerns.

While many countries around the world have reported shortages of antibiotics as respiratory infections return with a vengeance after the lifting of pandemic restrictions, the problem in Europe is particularly acute.