The FDA just issued new guidance on the MRI compatibility--or in some cases incompatibility--of implants that do not require electrical power to service their function, such as cardiovascular stents, intracranial aneurysm clips, endovascular grafts and transprostatic tissue retractors.
As lawmakers and regulators crack down on med tech companies launching corporate inversions for tax-paying purposes, the U.S. Internal Revenue Service is zeroing in on another tactic used by devicemakers like Medtronic and Covidien to guard offshore earnings and avoid steep domestic tax rates.
Last year, Sanofi's fourth-quarter flu vaccine sales soared on the introduction of a quadrivalent contender, surging more than 94%. Now, looking to keep that growth coming, the company is adding another four-strain shot to the mix.
Jazz Pharmaceuticals has kicked off a rolling FDA submission for defibrotide, a rare disease treatment acquired in its $1 billion buyout of Gentium.
Deputy director for science at the FDA's Center for Devices and Radiological Health, Bill Maisel, addressed the issue of long approval trials in a speech at Cambridge yesterday.
Amid escalating tension between Big Pharma and India's National Pharmaceutical Pricing Authority over price caps on "essential drugs," the NPPA has extended its pricing policies to cover 52 additional meds, including commonly used painkillers and antibiotics and drugs for cancer and skin disease treatment.
A federal judge in New York has decided Actavis CEO Brent Saunders' plan to move patients to a new version of its Alzheimer's treatment Namenda IR by stopping production on the older, patent-threatened version is not so clever. The court will order the drugmaker to keep making it for now.
Abbott Laboratories snagged a CE mark for its molecular diagnostic platform for blood-related infections, continuing its diagnostics winning streak and moving the company one step closer to securing stateside approval for its product.
Merck's Gardasil follow-up is here, meaning blockbuster sales are likely on the way. But they'll come at the expense of the previous iteration.
Merck won the FDA's blessing for a next-generation HPV vaccine designed to usurp Gardasil, putting it in line for billions in revenue.