Drugs

Judge Reverses $27.8 Million Xarelto Award

A Pennsylvania state judge has overturned a $27.8 million award approved by a jury for an Indiana couple who said Bayer and Johnson & Johnson failed to sufficiently warn about the risk of internal bleeding with their drug Xarelto (rivaroxaban). Reuters reports the judge ruled after a hearing on the companies’ motion to reverse the verdict, which they said was their first trial loss in litigation over the drug.

In the suit, a woman said she was prescribed Xarelto to prevent strokes as a result of atrial fibrillation. She took the drug for about one year and in 6/2014 was hospitalized with severe gastrointestinal bleeding, which she blamed on the drug. She has since recovered.

In her 2015 suit, the jury awarded $1.8 million in compensatory damages and $26 million in punitive damages.

The suit was one of about 21,400 the companies say are pending in federal and state courts. The companies said they welcomed the court’s decision and will continue to defend against the allegations in the other suits.

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