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.
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.
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.
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.
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.
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 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.
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.
The European Medicines Agency's experts have backed approval for two drugs that have already gained green lights for the U.S. market.
France drug regulator in January yanked Bayer's contraceptive Diane-35 off the market and insisted the European Medicines Agency investigate its off-label use as an acne treatment and its risks of blood clots. The EMA has done that and has come down in support of the drug, even for the off-label use.