European Medicines Agency

Latest Headlines

Latest Headlines

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.

EMA: No new safety flags in Roche's stash of unreported side effects

A European Medicines Agency probe found that Roche failed to flag tens of thousands of side-effect reports, EMA reviewers said. But sifting through those unreported adverse events didn't turn up any new safety worries on Roche's leading drugs, as some had feared.

EMA warns of possible delay to final trial data transparency policy

When the European Medicines Agency released its draft policy on clinical trial data disclosure in June, it expected a big response. And it got one, with more than 1,000 comments submitted in the four-month consultation period. Working through this feedback is taking a little longer than expected, though.

EMA to start accepting digital signatures next month

Over the past 18 months the European Medicines Agency (EMA) has kick-started its electronic submissions project. The eSubmission Gateway went live in April 2012, and now the EMA is set to roll out the next phase of the initiative--digital signatures.

Celgene's blood cancer therapy nabs European approval

Celgene has received the stamp of approval from the European Commission for its oral medication pomalidomide, in combination with the steroid dexamethasone, for the treatment of relapsed and refractory multiple myeloma in patients who have received previous therapies.

Big Pharma agrees to widen access to clinical trial data

After dragging their feet in opposition to proposed European rules that would require public sharing of clinical trial data, pharma companies have conceded, agreeing to make certain information widely available.

Bayer, Raptor reel in endorsements from EMA for new therapies

The European Medicines Agency's experts have backed approval for two drugs that have already gained green lights for the U.S. market.