European Medicines Agency (EMA)

Ten new medicines recommended for approval by EMA

The European Medicines Agency Committee for Medicinal Products for Human Use has recommended ten medicines for approval, including one biosimilar and two orphan medicines…

Adalimumab biosimilar exhibits same efficacy and safety for rheumatoid arthritis as originator

Patients with rheumatoid arthritis who switched from adalimumab (Humira) to its biosimilar, adalimumab-adbm (Cyltezo), saw no clinically meaningful difference, according to the results of a 48-week Phase III clinical trial…

Too many cancer drugs, too few survival benefits

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EMA calls for feedback on new guidance to support development of medicinal products against RSV

New guidelines to support the development of vaccines and medicines to prevent and treat infections caused by the respiratory syncytial virus have been released for consultation by the European Medicines Agency…

UK could lose its influence when EMA leaves UK, Hunt says

The UK could lose influence when the European Medicines Agency (EMA) leaves London following Brexit, health secretary Jeremy Hunt has admitted to MPs.…

Indicators developed to measure EU progress on tackling antibiotic resistance

A set of outcome indicators has been developed to help EU member states monitor their progress in combating antimicrobial resistance.…

Avoiding medicines stalemate post Brexit

With three rounds of negotiations concluded and little agreed, the reality of a no-deal Brexit looms large over both the European Medicines Agency (EMA) and the Medicines and Healthcare products Regulatory Agency (MHRA).…

Relocation of the EMA: implications for medicines regulation

On 20 November, the General Affairs Council of the European Union will officially announce the new location of the European Medicines Agency (EMA).…

Cities compete to host EMA

The European Medicines Agency (EMA) has assessed the bids of 19 cities that have applied to host its headquarters following the UK’s exit from the European Union in 2019. The final relocation decision will be made by the European Council on 20 November 2017.…

Sales of veterinary antibiotics fall across Europe

The sales of veterinary antibiotics are declining in most countries in Europe, a report from the European Medicines Agency (EMA) has found.…