European Medicines Agency
Coverage of European Medicines Agency in the Nexus archive.
- STAT+: European regulators take steps to bolster clinical trial transparency
European regulators, specifically the European Medicines Agency (EMA), are taking rapid action to enhance clinical trial transparency. An analysis revealed that less than half of studies in the Clinical Trial Information System (CTIS) met reporting deadlines, with only 42% fully reporting results. The CTIS was established in 2022 to improve transparency across the European Union and European Economic Area.
- Most of Wall Street rises, but sinking AI stocks keep it on track for a losing week
Most U.S. stocks rose Friday as oil prices retreated from wartime highs, but declines in AI stocks limited gains. The S&P 500 remained nearly flat, on track for its second weekly loss in 13 weeks due to AI sector pressures. Health care stocks gained after European drug approval recommendations, while United Airlines and Eli Lilly rose on lower oil costs and regulatory news.
- EMA oversight sparks friction in medical devices overhaul
Italy and Czechia are opposing a proposed expansion of the European Medicines Agency's decision-making role in the overhaul of medical devices regulations. The move has sparked friction among stakeholders involved in the regulatory process.
- FIRST AID: EMA warns on HTA side effects
The European Medicines Agency (EMA) has issued a warning regarding side effects associated with HTA. The article also mentions nicotine pouches, deadly heat, and dioxine as related topics.
- Europe—not US—first to authorize Moderna's combo mRNA flu-COVID vaccine
Moderna's mRNA-based combination vaccine against flu and COVID-19, mCOMBRIAX (mRNA-1083), has been authorized in Europe by the European Commission, making it the first such combo vaccine. The US, where it was developed, has not yet approved it. The vaccine aims to simplify immunization for high-risk adults and strengthen healthcare systems.