European Medicines Agency
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.
Drugmakers in Europe have been sweating over whether China and India will meet a looming deadline to certify their APIs meet EU standards. An update from the European Commission is not likely to stop the fretting and the sweating. It says that both countries have made progress but do not have the process nailed down.
The European Medicines Agency's drug-review committee has recommended approval for Sanofi's new multiple sclerosis treatment Aubagio. But the EMA says it doesn't deserve "new active substance" status, because it's a revamped version of a much older drug. And that means Sanofi's monopoly would be severely limited.
GlaxoSmithKline's move to rehabilitate its reputation with a commitment to open up its data vault on approved drugs has won widespread acclaim, and at least limited support from Roche. Read more >>
The European Medicines Agency has opened a debate on the safe use of animal-derived products in vaccines. Publication of the draft guidelines comes three years after the discovery of pig-virus DNA in vaccines from GlaxoSmithKline ($GSK) and Merck ($MRK) prompted a regulatory rethink.
Sanofi is one step closer to marketing its latest 6-in-one children's vaccine in Europe, winning the support of the European Medicines Agency's Committee for Medicinal Products for Human Use.
The European Medicines Agency and the European Commission gave Intercell renewed hope by granting it marketing authorization of Ixiaro in 27 EU member countries and Norway, Liechtenstein and Iceland.