Drugs

Janssen Files sNDA for Xarelto Cardiovascular Benefits

Janssen Research & Development has submitted a supplemental NDA for two new Xarelto (rivaroxaban) vascular indications: reducing the risk of major cardiovascular (CV) events such as CV death, heart attack or stroke in patients with chronic coronary or peripheral artery disease (CAD/PAD), and for reducing the risk of acute limb ischemia in patients with PAD. The submission is based on data from the COMPASS study, which showed that Xarelto 2.5 mg twice daily plus aspirin 100 mg once daily significantly reduced the risk of major CV events by 24% compared to aspirin alone. The study was stopped early due to efficacy, and its results were presented during a medical meeting earlier this year.

Xarelto (rivaroxaban) is approved to reduce the risk of stroke and blood clots in people with atrial fibrillation that is not caused by a heart valve problem. It is also used to treat deep vein thrombosis and pulmonary embolism, and to reduce the risk of blood clots happening again in people who continue to be at risk for these conditions.

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