Topic:

Regulatory

Latest Headlines

Latest Headlines

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.

Judge tosses Xolair kickback suit against Novartis, Genentech

Novartis and Roche can wash their hands of some kickback accusations. A federal judge tossed a long-standing whistleblower suit Tuesday, nixing allegations that the two drugmakers used kickbacks and off-label promotions to pump up sales of their asthma drug Xolair.

Boston Scientific implantable defibrillator gets FDA green light

Boston Scientific announced that it has received FDA and CE-mark approval to launch the next generation of its subcutaneous implantable defibrillator system, which is implanted under the skin and does not have wires that come into contact with the heart.

Deep dive into Actelion's Uptravi data calms investors as FDA decision date nears

Actelion has presented detailed data on the drug it hopes will cement its position in the pulmonary arterial hypertension market, Uptravi. The shock-free data drove a small uptick in Actelion's stock, but fell short of being the blockbuster-guaranteeing release some were hoping to see.

HK gives nod to Celgene's Abraxane for late-stage pancreatic cancer

Hong Kong's Department of Health has approved Celgene's Abraxane as a new treatment option for late-stage pancreatic cancer, following an international Phase III clinical trial, one of the largest ever conducted in metastatic pancreatic cancer.