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European Medicines Agency

Latest Headlines

Latest Headlines

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. 

EU pushes Bayer PAH drug Adempas further down the road

Germany-based Bayer got an added boost today for its lung disease drug Adempas when the European Medicines Agency's Committee for Medicinal Products for Human Use recommended approval for the treatment of both chronic thromboembolic pulmonary hypertension and pulmonary arterial hypertension.

EMA makes inspection reports public

The European Medicines Agency is now making public its reports on companies that have failed plant inspections. The FDA has made warning letters and some Form 483 reports public for some years, but the EMA had not, according to  Pharmafile, which went through the nearly 7 dozen reports in the data base that date back to 2007.