Tag Archive for: European Medicines Agency (EMA)

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.

Novartis’ sickle cell disease therapeutic Adakveo (crizanlizumab) is under review by the European Medicines Agency’s Committee for Medicinal Products for Human Use after failing to replicate previous efficacy results in a Phase III trial.

The European Union’s health regulator has advised the use of antiviral treatments over monoclonal antibodies to treat COVID-19 in patients at risk of their condition worsening, citing concerns over decreasing effectiveness against newer virus variants.

Ionis Pharmaceuticals Inc. announced that the European Medicines Agency (EMA) has accepted the marketing authorization application (MAA) for review of tofersen, an investigational medicine for the treatment of superoxide dismutase 1 (SOD1) amyotrophic lateral sclerosis (ALS). SOD1-ALS is a progressive and uniformly fatal disease that affects fewer than 1,000 people across Europe.

Recent uptake of COVID-19 vaccine booster doses in the European Union has been “rather disappointing,” an official said on Thursday, amid concerns that protection against severe cases of the disease could weaken during the winter.

Sanofi said on Thursday it won European Union approval for its COVID-19 vaccine booster, jointly made with British partner GSK, after a drawn-out development effort that saw the pair fall behind now-dominant vaccine suppliers.

An official at the European Union’s drugs regulator said on Tuesday the COVID-19 pandemic was not over, contradicting U.S. President Joe Biden, and that a planned vaccination campaign in the region during the cold season was key to fighting it.

France’s national health body warned on Friday of a resurgence of COVID-19 cases in the country, and urged people to continue to get vaccinated to protect themselves against the virus.