Topic:

Regulatory

Latest Headlines

Latest Headlines

IRS battles it out with Medtronic and Covidien over offshore tax paying tactic

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.

Sanofi adds another quadrivalent to its quiver with Fluzone Intradermal approval

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 heads to the FDA with its $1B rare disease drug

Jazz Pharmaceuticals has kicked off a rolling FDA submission for defibrotide, a rare disease treatment acquired in its $1 billion buyout of Gentium.

FDA works to improve medical device approval times

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.

India's NPPA extends pricing policy on drugs, adding fuel to price cap fire

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.

Actavis plan to stop making original Namenda derailed by court

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 snags CE mark for molecular diagnostic platform for sepsis

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 next-gen Gardasil wins FDA approval

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 wins FDA approval for Gardasil's heir

Merck won the FDA's blessing for a next-generation HPV vaccine designed to usurp Gardasil, putting it in line for billions in revenue.

St. Jude gains CE mark for first pacemaker with MultiPoint Pacing

St. Jude Medical has gained approval for a quadripolar cardiac resynchronization therapy pacemaker that for the first time incorporates its MultiPoint Pacing technology that's been shown to be better for patients who don't respond to traditional biventrical pacing.