Drugs

Bayer/Janssen Pay $775 Million to Settle Xarelto Claims

Bayer and Janssen Pharmaceuticals have agreed to pay $775 million to settle about 25,000 claims against blood thinner Xarelto (rivaroxaban) and alleged serious and sometimes fatal bleeding episodes. Bayer expects its liability insurance to cover part of the settlement costs. While the companies say the claims are without merit and there is no admission of liability under the agreement, the settlement would end the distraction and significant cost of continued litigation.

In a statement from Janssen, the company says it is hopeful that the settlement will reduce or end news coverage of the litigation and plaintiff lawyer ads trying to recruit clients to join the litigation. “The ads frequently contain unsubstantiated, incomplete and misleading claims about the medicine,” the company says, adding that it can “create barriers to the critical doctor-patient relationship and complicate decisions about treatment options. The consequences of this lawyer advertising can also be deadly. Throughout this litigation, we have received independent reports of deaths, strokes and other adverse consequences due to patients viewing plaintiff lawyer advertising and stopping their prescribed anticoagulant medications.”

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