Biologics

More Data Needed on Glaxo COPD Add-on Drug

FDA has issued GlaxoSmithKline a complete response letter for its supplemental BLA for mepolizumab as an add-on treatment to inhaled corticosteroid-based maintenance treatment for reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD), guided by blood eosinophil counts. The letter states that more clinical data are required to support an approval decision. The company says it will work closely with the agency to determine the appropriate next steps.

Mepolizumab is a first-in-class monoclonal antibody that targets IL-5, and was first approved in 2015 for severe eosinophilic asthma. It is believed to work by preventing IL-5 from binding to its receptor on the surface of eosinophils, the company says. Inhibiting IL-5 binding in this way reduces blood eosinophils.

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