The clinical side of orphan drug use has many twists and turns, not least of which is matching patient ability to pay with the right drug and an openness to understand the dynamics of a "Dallas Buyers Club" approach to use.
The European Medicines Agency recommended 20 new veterinary drugs for approval in 2014--the highest number of positive opinions it has issued in the past 5 years in animal health.
The Marketing Authorization Application for SB4, the Enbrel (etanercept) biosimilar candidate developed by Korean biopharmaceutical company Samsung Bioepis, has been validated and accepted for review by the European Medicines Agency. It will become the first Enbrel biosimilar subjected to regulatory review in the European Union.
The European Medicines Agency (EMA) has taken another step toward the creation of a database of all suspected adverse reactions reported within its jurisdiction. The EMA laid out the technical details of the system and how it will affect biopharma companies in a 100-page guide it published this week.
The European Medicines Agency has accepted AstraZeneca's application for lesinurad, a gout treatment with a checkered efficacy record, stoking the company's hopes that it can make the drug into a blockbuster.
The EMA responded quickly to the publication of the letter, issuing a release to outline its approach to the redaction of commercial confidential information.
The European Medicines Agency didn't follow procedure when it appointed Executive Director Guido Rasi, a court has ruled, forcing the continent's top drug regulator to step down and sending the organization scrambling for answers.
For three years, Guido Rasi has been Europe's top pharma regulator, moving aggressively to restore the image of the European Medicines Agency. But his future there is now in doubt, sidelined by a colleague who was miffed that he was not picked for the job himself, the Financial Times reports.
Increased reliance on software to support aspects of drug development has simplified many tasks but created the possibility that an IT glitch could have far-reaching implications. Now, the European Medicines Agency is to discuss whether this situation has already happened.
After years of debate and a late controversy, the European Medicines Agency has adopted a clinical trial transparency policy that will come into force on January 1. And unlike a recent draft of the policy, the final version allows researchers to download the data.