Tag Archive for: European Union

The drugmaker stated that the Committee for Medicinal Products for Human Use’s (CHMP) positive opinion was an “important recognition of the unmet medical need among adolescents living with obesity and the need for additional treatment options”.

Europe will lose out to countries like the U.S. and Japan on new medical research, trials and treatments unless draft rules reforming the European pharmaceutical landscape change, the CEO of Danish drugmaker Novo Nordisk warned on Thursday.

Pfizer Inc. and its German partner BioNTech SE (22UAy.DE) have applied for emergency use authorization of their Omicron-adapted COVID-19 vaccine in the United States as a booster dose for children aged six months through four years, the companies said on Wednesday.

European Commission President Ursula von der Leyen’s silence about her dealings with drugmaker Pfizer leading to the EU’s biggest COVID-19 vaccine contract is hurting public trust and is a problem that will not go away, its ombudsman said.

The antiviral pill, brand named Lagevrio, could not demonstrate benefits in treatment of COVID patients who do not need oxygen support and are at risk of their disease worsening, the European Medicines Agency said.

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.

The companies announced today that the EU approval is indicated for treating children as young as 6 months old with severe atopic dermatitis.

Although nearly all the countries in Europe are reporting shortages, the EMA is not going to label the ongoing shortage of antibiotics in the continent a “major event”, according to a source familiar with the matter.

The letter sent to the European Medicines Agency comes as antibiotics, including amoxicillin – used to treat bacterial infections and often prescribed for ear and chest infections in children – have been in short supply since October.

The European Cancer Imaging Initiative is an effort to speed up innovation and early cancer diagnosis using artificial intelligence.