European drug agency to appeal ruling that it stop releasing trial dataBMJ 2016; 354 doi: https://doi.org/10.1136/bmj.i5331 (Published 30 September 2016) Cite this as: BMJ 2016;354:i5331
- Nigel Hawkes
The European Medicines Agency is at loggerheads with an EU court over the disclosure of trial data.
At the end of July the president of the EU General Court (a constituent court of the Court of Justice of the European Union) made interim orders prohibiting the agency from releasing a clinical study report on ataluren (which is marketed as Translarna), a drug for Duchenne muscular dystrophy, and three toxicology reports relating to fluralaner (Bravecto), a treatment for tick and flea infestations in dogs.
In both cases requests for the documents had been made by other drug companies and …