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.
European authorities have battered expectations for Pfizer's rheumatoid arthritis pill Xeljanz, spurning the drug giant's request for approval over concerns about the risk-benefit profile. The surprise rejection cools the company's run of regulatory success, which included 5 FDA approvals in 2012.
The labeling logo is designed to encourage doctors and patients to report side effects, as part of a new effort to more closely monitor drug safety. The list of 100-plus products includes all new drugs and biologics approved since January 2011.
Citing heart risks, an EMA committee has recommended further restrictions for Protelos, an osteoporosis drug made by Servier, the company at the center of a scandal in France for off-label use of its Mediator diabetes drug, which also was tied to heart risks.