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Regulatory

Latest Headlines

Latest Headlines

Medtronic's stent for peripheral artery disease wins expanded indication from FDA

After staving off Treasury Department rules, angry politicians and antitrust regulators, Medtronic is earning early victories from its $50 billion mega-acquisition of Covidien. The company announced that the former rival's Protégé GPS peripheral stent for treating peripheral artery disease now has the FDA's blessing to be used against lesions in the common and external iliac arteries, located in the pelvis.

FDA will discuss challenges and opportunities of robotic surgery at public meeting this summer

The FDA is putting robot assisted surgery in the spotlight this summer. 

Lawsuit would force FDA to ban or label wheat gluten as ingredient

Celiac sufferer Michael Weber is suing the FDA for dragging its feet on a citizen petition he filed in 2008. The lawsuit attempts to force the FDA to either ban gluten from use in drugs or at least require labels to indicate it is an ingredient in prescription and over-the-counter drugs.

Indonesia drug industry investment lags despite universal insurance program

Indonesia's new and ambitious healthcare program has done little to infuse new money into the country's pharmaceutical industry, partly because of a long-term weakness in the nation's currency, the rupiah, according a review of company reports.

U.S.-based lawsuits pile up for Japan's Olympus in superbug case

Olympus Medical Systems has received its fifth suit filed by a patient claiming to have been infected with the hospital "superbug" as a result of inadequate sterilization of its duodenoscope.

India's Wockhardt, Granules, suggest recent FDA inspections went well

India's Wockhardt and Granules India each reported surviving a U.S. FDA inspection without any problems being cited.

Wockhardt says FDA impressed by the strides it made at a banned plant

FDA actions against Wockhardt have piled up over the last couple of years with warnings letters for two plants in India that the FDA also banned in 2013 from shipping products to the U.S. But the Indian drugmaker suggests one of those facilities has started digging out from under the mountain of issues raised by the FDA.  

England's Cancer Drugs Fund changes its tune, holds onto Novartis' Afinitor

England's Cancer Drugs Fund is backtracking in its decision to remove certain treatments from its list of covered drugs, agreeing to keep Novartis' cancer med Afinitor for two of the three indications for which it was supposed to be removed.

Diabetes research advocacy groups call for better insulin pump regulation

The American Diabetes Association and the European Association for the Study of Diabetes have published a statement calling for the adoption of improved and harmonized safety standards for insulin pumps.

Retrophin bags rare disease approval, FDA voucher in $75M deal

Orphan drug biotech Retrophin is the new owner of an FDA-approved rare disease treatment and a potentially lucrative voucher for a future speedy review thanks to a $75 million buyout agreement.