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European Medicines Agency

Latest Headlines

Latest Headlines

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.

EMA backtracks on clinical trial data download ban

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.

Boehringer's lung disease drug hits the EU fast track in a race with InterMune

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.

EU ombudsman probes link between AbbVie case and trial transparency U-turn

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.

BMJ accuses EMA of watering down open trial data policy

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.

EMA criticized for flip-flopping on clinical trial data transparency

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.

Counterfeits of Roche's Herceptin found in EU supply chain

European authorities are warning that vials of Roche's cancer med Herceptin that were stolen in Italy are now showing up across the continent with little or none of its active ingredient.

Digital documents: Can electronic tools ease biopharma's clinical trial file headaches?

Clinical trials have increased in complexity over the past decade, with sponsors working with an increasing number of sites, countries and service providers. These massive globalized studies place new strains on the organization of essential study documents, collectively known as the trial master file.