Biologics

Noninferiority Trials Can Identify Innovations: Study

Harvard Medical School researchers say that noninferiority clinical trial designs are being applied more commonly and broadly and when appropriately designed and executed can identify innovative treatment alternatives with clinical value. Writing in the New England Journal of Medicine, the authors say that noninferiority trials “have become a major tool for the evaluation of drugs, devices, biologics, and other medical treatments.”

The article provides a framework for considering the features, including pitfalls, or noninferiority studies. It uses cardiovascular treatment trials as examples, while acknowledging that noninferiority trials can be conducted in many fields.

Suggestions the authors make for improving noninferiority trials include: providing an explicit justification of the acceptable margin that is based on a measurement or anticipated benefit of the experimental treatment, being cautious when considering composite endpoints that may include components with discordant benefits and risks, and strongly considering sensitivity analysis regarding missing data in the planning and analysis of noninferiority trials.

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