Tag:

CHMP

Latest Headlines

Latest Headlines

EMA hands Novartis good news on Xolair but a rebuke for serelaxin

Swiss drugmaker Novartis got a mixed bag of news from European regulators Friday. It got a recommendation for its asthma drug Xolair to treat a chronic form of hives. Regulators, however, slapped down its new heart drug serelaxin, a product that Novartis is counting on bringing in more than a billion dollars a year.

Bristol-Myers, AstraZeneca get EU nod for diabetes drug

AstraZeneca and Bristol-Myers grabbed a win in the EU today for one of the drugs sprung from their diabetes treatment partnership. But the recommended approval comes even as questions have bubbled up about the future of that relationship.

Ariad's Iclusig further restricted by EMA

Drugmaker Ariad left its European operations untouched last month when it took an ax to its workforce after the FDA requested it pull its leukemia drug Iclusig off the market in the U.S. Regulators in the EU did not make the same request, but they also did not ignore the clotting risks that raised a red flag at the FDA.

Glaxo, Roche, J&J and others score backing on big day for EU regulator

Friday, the EU's Committee for Medicinal Products for Human Use (CHMP) recommended 11 new drugs for a variety of diseases--the most nods it's given in a single meeting all year.

EU decision a rare positive for Dendreon

In the two years since cancer vaccine maker Dendreon sent its share price into a precipitous decline by pulling the forecast on its debut drug, Provenge, bad news has mounted up. Weak sales drove shares down 30% last year, and the slide has continued in 2013.

Europe's CHMP recommends 10 drugs in 1 week

It was a very, very big week in Europe for drugmakers. The European Committee for Medicinal Products for Human Use (CHMP) recommended 10 drugs for approval, including two biosimilars, it said today.

Dendreon's Provenge gets recommendation in Europe

Dendreon today got the best news it has had in a long time for its prostate cancer vaccine Provenge, a thumbs up from the Europe's Committee for Medicinal Products for Human Use (CHMP) for approval in Europe.

Arena pulls app for weight-loss drug Belviq in EU

Arena Pharmaceuticals has decided to take its drug application and go home. The drugmaker Friday said it was giving up for now on breaking through the European wall of resistance to its weight-loss drug Belviq. The company, which got FDA approval last year, yanked its application with little explanation.

Pfizer appealing CHMP ruling on RA treatment Xeljanz

Pfizer has big expectations for its oral rheumatoid arthritis treatment Xeljanz--about $3 billion worth. But those expectations were struck a serious blow when European Medicines Agency regulators Thursday turned it down for approval.

UPDATED: Novartis has a win some, lose some day with Gleevec

Novartis and its cancer drug Gleevec had one of those days that starts off not looking so good and then something comes along to turn things around.