In an order filed Tuesday, U.S. District Judge Paul Gardephe refused to dismiss claims that Novartis lavished entertainment on certain physicians in return for increased prescriptions.
Days after Health Canada said it would talk to the FDA about Apotex, the regulator has banned the import of finished dosage forms and APIs from two of the drugmaker's plants in India.
Allergan announced that the FDA has approved the company's Ozurdex sustained-release biodegradable implant to treat diabetic macular edema (DME). The expanded indication means the therapy, based on a proprietary delivery system, is approved for use in the general DME population, not just those with an artificial lens implant or in need of cataract surgery.
Valeant Pharmaceuticals has grown quickly over the past few years as it has pursued, bought and divested pharmaceutical assets. But somewhere along the way oversight of a supplier slipped. The FDA spotted the problems during a recent visit to Valeant's U.S. headquarters, leading to the posting of a warning letter.
Ireland's Trinity Biotech gained a CE mark for its new heart failure point-of-care diagnostic and is now turning its sights toward the U.S. regulatory process within the next few months.
Salix Pharmaceuticals nabbed the new Relistor approval it was counting on. The FDA blessed the injectable drug as a treatment for all patients with constipation caused by opioid pain relievers, boosting its target market more than tenfold.
A study published Sept. 29 in The Journal of the American Medical Association concluded that publicly available information to support the safety and effectiveness of implanted, 510(k)-cleared devices is lacking.
Nightscout touts itself as an open source, do-it-yourself project to enable remote monitoring of blood glucose levels of patients with Type 1 diabetes.
Gilead has been seeking FDA approval for HIV drugs Tybost and Vitekta for a while now, but the agency dealt the drugmaker a setback with Complete Response Letter last year. Now, 17 months later, the two have passed muster.
Infraredx isn't a big company yet. But the Massachusetts maker of an intravascular imaging system designed to help diagnose and manage coronary artery disease continues to meet major goals for international expansion. The latest: Japan's regulators granted approval for its signature device.