Tag:

European Medicines Agency

Latest Headlines

Latest Headlines

EMA posts guide to help IT teams with its new pharmacovigilance database

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.

AstraZeneca's $1.3B gout drug comes under EU scrutiny

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.

Ombudsman pushes EMA for explanation of Humira CSR redactions

The EMA responded quickly to the publication of the letter, issuing a release to outline its approach to the redaction of commercial confidential information.

EU's top regulator canned on a technicality

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.

EMA director Rasi sidelined by complaint from colleague who wanted his job

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.

EMA to discuss possible glitch in Thermo bioequivalence software

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.

EMA overturns ban on data downloads in final transparency policy

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.

UPDATED: Europe approves Gilead's cancer drug Zydelig amid challenging pricing environment

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.

Wearables project aims to provide new source of data for MS trials

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.

EMA approves 39 drugs in H1, down from 44 last year

The European Medicines Agency approved 39 new drugs in the first half of the year, PharmaTimes reports.