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.
The approval puts Gilead well on track to meet analyst expectations that Zydelig (idelalisib) will be hauling in $1.2 billion in annual sales by 2020, though there's little doubt Gilead will face pressure from European health agencies to keep a lid on the new drug's price.
The study aims to recruit 40 people in the United Kingdom to wear watch-sized sensors on their belts. By placing the sensors around the body's center of mass the team from Imperial College London hope to gather data on each individual's position and walking speed.
The European Medicines Agency approved 39 new drugs in the first half of the year, PharmaTimes reports.
The controversy surrounding the European Medicines Agency's trial data transparency draft terms put this week's management board meeting in the spotlight, with campaigners hoping the regulator would rethink its policy. And to an extent, the EMA did, but the compromise it proposed is unlikely to fully satisfy either side of the debate.
The European Medicines Agency has agreed to an accelerated review of Boehringer Ingelheim's much-watched lung disease therapy, likely shortening its path to market.
With days to go until the European Medicines Agency meets to finalize its clinical trial data policy, the region's ombudsman has confirmed she is probing a possible link between a settlement with AbbVie and a shift in the transparency plans.
As Europe prepares to open its clinical trial data vaults in a move toward greater transparency, the British Medical Journal is criticizing the European Medicines Agency for seemingly backtracking on its promises to make important information available to consumers.
When European politicians voted overwhelmingly in favor of a clinical research data sharing law last month, it looked like a big step forward for transparency campaigners. Yet just weeks later researchers have raised concerns that the European Medicines Agency is already trying to lessen the impact of the legislation.