Drugs

ev3 Agrees to Plead Guilty and Pay $18 Million

The U.S. Justice Department has announced that medical device manufacturer ev3 has agreed to plead guilty to introducing an adulterated medical device into interstate commerce. The Onyx Liquid Embolic System is approved for use as a device that is surgically injected into blood vessels to block blood flow to arteriovenous malformations in the brain. From 2005 to 2009, company sales representatives “encouraged surgeons to use Onyx for unproven and potentially dangerous surgical uses outside the brain,” the government says. “The firm also set up a system of sales quotas and bonuses that incentivized sales representatives to sell the device for unapproved uses and trained the sales force on how to instruct physicians on unapproved uses of the device. The company, ev3, is expected to pay a criminal fine of $11.9 million and forfeit $6 million.”

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome