Drugs

Cumberland Recruiting MS Study Participants

Cumberland Pharmaceuticals says it is looking for 48 Duchenne muscular dystrophy (DMD) patients age 7 and older for a Phase 2 FIGHT DMD study funded by FDA to evaluate the safety, efficacy, and duration of effect of its oral ifetroban therapy for cardiomyopathy linked to DMD. A company statement says the study will be conducted at various U.S. locations and will assess participants’ heart and lung function, muscle strength, daily activity, and quality of life.

Ifetroban is described as an inhibitor of the thromboxane receptor that works by reducing fibrosis and fat deposits in the heart. Cumberland says a study has shown that it prevents scarring of the heart tissue and improved survival in mouse models of muscular dystrophy.

FDA awarded Cumberland $1 million from the orphan product grant program to support the trial.

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