The FDA has approved its first adjuvanted vaccine against a potential outbreak of the deadly bird flu. It just won't be available at the local pharmacy.
The whole pay-to-delay issue has gotten a lot of attention in the U.S., particularly with the U.S. Supreme Court this year making it easier for regulators and payers to attack those deals. But Europe also thinks the deals tend to stink for patients and government payers, and it has begun issuing fines to alleged violators. Next up looks to be Novartis and Johnson & Johnson.
France's AB Science watched its shares tank as much as 31% on Friday after a European Medicines Agency panel rejected its gastrointestinal cancer treatment, casting serious doubts on the drug's potential approval.
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.
The European Medicines Agency Friday granted Tecfidera just what Biogen has been waiting for--a "new active substance" designation, paving the way to even greater sales for the hot product.
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.
Forest Laboratories has a slate of new products meant to be its life raft. But what happens when one of those new products--the antipsychotic drug cariprazine--gets a thumbs down from the FDA?
The FDA set up a potentially serious roadblock for Forest Laboratories and its partner Gedeon Richter, rejecting their application for the schizophrenia/bipolar drug cariprazine and likely delaying any possible approval until the agency gets additional clinical trial data.
GE Healthcare has gotten FDA approval for its plant in Oslo, Norway, to make a heart imaging agent. The company said that with approval, it will be the only contrast media manufacturer to supply its own stock to the U.S.
Roche's Kadcyla, a drug some refer to as a "super Herceptin," was approved by the European Commission Wednesday for patients with previously treated HER2-positive advanced breast cancer.