Topic:

Regulatory

Latest Headlines

Latest Headlines

GSK's Breo for asthma? FDA panel says yes--but only in adults

Good news for GlaxoSmithKline: An FDA panel of experts says the efficacy and safety data for blockbuster wannabe Breo support the asthma indication it's gunning for in adults 18 and older. When it comes to children aged 12 to 17, though? The panelists aren't having it.

U.S. FDA softens approach in meetings with Indian regulators

The U.S. FDA is adopting a "carrot and stick" approach to the problems with India's pharmaceutical production. The new plan calls for rating India drugmakers and providing incentives for meeting good manufacturing practices along with use of its usual enforcement tools.

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.