The new Clinical trial regulation (CTR) - which enters into force at the end of the month - together with the Accelerating clinical trials initiative (ACT EU) aiming to gain back EU's position among clinical research leaders worldwide.
A new Lancet publication found that most clinical trials conducted in Europe were too small and did not provide meaningful results on the COVID-19 pandemic. According to one of the authors of the publication, Herman Goossens, "the world failed in clinical research response".
Europe's drugs regulator said on Monday (16 August) that it was evaluating the use of Roche's arthritis drug, Actemra, in hospitalised adults with severe COVID-19, in its latest review of a potential coronavirus treatment.
A preliminary study investigating the safety and effectiveness of a vaccine against COVID-19 has found the vaccine to be "safe" and that it triggered a "significant" immune response in human volunteers.
The new European Commission should tackle "head-on" rheumatic and musculoskeletal diseases, the president of the European League Against Rheumatism (Eular) told EURACTIV in an interview, referring to chronic diseases that affect one-quarter of all Europeans, creating healthcare and social security costs.
The EU's preparedness for outbreaks of infectious disease has increased, but member states still need to overcome ethical, administrative, regulatory and logistic bottlenecks for boosting clinical research, medical experts said at a scientific meeting in Brussels.
The Commission’s upcoming proposal on Health Technology Assessment (HTA) will focus on clinical aspects and leave member states to decide on economic or ethical parts, a European Commission spokesperson told EURACTIV.com.
“Salami-slicing” the cost of medicines, which represent almost one-fifth of health system budgets and are subject to rigorous value assessments, won’t make healthcare systems more sustainable in the future, Nathalie Moll told EURACTIV.com in an interview.
The European Medicines Agency approved 39 new cancer drugs between 2009 and 2013 despite having no evidence that they worked, unnecessarily exposing patients to toxicity, researchers said Thursday (5 October).
Britain's biotech sector boasts the strongest new drug pipeline in Europe but industry leaders say it needs continued access to global talent, funding and regulatory clarity to thrive in the future - all of which could be jeopardised by Brexit.
The African Unions EU representative, Ajay Bramdeo, told EURACTIV Germany that plans for a Marshall Plan for Africa are fundamentally good but warned that the continent needs to be the focus and that healthcare must be the priority.
Unless the European Commission changes its attitude, the innovation gap between Europe and the US will likely increase, and it could be overtaken soon by China, with dire consequences for living standards, warns Philip Stevens.
EXCLUSIVE / National healthcare systems should embrace the digital era and use Health Technology Assessment (HTA) to become truly sustainable and cost-effective, European Commissioner for Health and Food Safety Vytenis Andriukaitis told EURACTIV.com in an interview.
An upcoming assessment by a European Commission committee on the risks of UV radiation and sunbeds is hamstrung by in-built bias and a failure to comprehensively address all the issues, warns Frank Harbusch.
The UK's vote to leave the European Union has come at a crucial moment in the development of an international medical project that throws into sharp relief the state of flux Brexit has cast over collaborative research, says Jack Barton.
A new breed of drugs, called “value added medicines”, could help patients improve their everyday life while in treatment, without increasing healthcare budgets, Christoph Stoller said in an interview with EURACTIV.com