Drugs

BMS Opdivo Trial Misses Primary Endpoint in Lung Cancer

Bristol-Myers Squibb has reported disappointing topline results from its Phase 3 CheckMate -331 study evaluating Opdivo (nivolumab) versus the current standard of care, topotecan or amrubicin, in patients with small cell lung cancer (SCLC) who relapsed following platinum-based chemotherapy. The study did not meet its primary endpoint of overall survival for patients treated with Opdivo versus chemotherapy. Opdivo’s safety profile in the trial was consistent with that seen in previously reported monotherapy studies, the company says. Bristol-Myers adds that it is continuing investigating the role of Opdivo plus Yervoy and Opdivo monotherapy versus placebo in frontline setting as a maintenance therapy for patients with SCLC who do not progress on first-line chemotherapy.

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