Direct-to-consumer DNA testing outfit 23andMe has run afoul of the FDA, and the agency served up a warning letter demanding that the company take its genetic screens off the market until it gets the proper clearance.
Novo Nordisk won the endorsement of a key European regulatory committee for a device designed to work in tandem with a Roche insulin pump to help simplify treatment for diabetics. A CE marking is likely and could open lucrative doors for both companies.
The creation of the new site follows a surge in visits by people using mobile devices. Almost 1-in-4 visitors to FDA.gov now uses a mobile device.
While the recent hack of FDA databases raised plenty of questions about its cybersecurity policies, the agency offered few answers. If a damning new report into government-wide practices is in any way representative of the FDA though, the agency will need to tighten up.
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.