Drugs

Enough Women in Some CV Clinical Trials: Researchers

FDA researchers say that women were well represented in trials of drugs for hypertension and atrial fibrillation, and over-represented for pulmonary arterial hypertension. However, the representation of women fell below a participation to prevalence ratio of 0.8 for trials in heart failure, coronary arterial disease, and acute coronary syndrome. Writing in the open-source Journal of the American College of Cardiology, the FDAers say that over the past several decades, women’s participation in clinical trials has improved in some, but not all, cardiovascular disease areas.

The researchers studied women’s participation in cardiovascular disease trials supporting NDA approvals, as well as gender differences in trial results. The proportion of women enrolled in cardiovascular trials supporting drug approvals ranged from 22% to 81%, with participation varying by disease area.

The study concludes that future research is needed to identify factors leading to under-participation of women in cardiovascular clinical trials, particularly those occurring before screening. “Research is needed to better define barriers that limit participation of diverse populations, not only of women, but also of minorities and the aged,” the authors say. “….As we move into the era of precision medicine, that is, assessing the impact of a wide range of patient and disease characteristics on drug effects, it is imperative that clinical trial participants represent the full spectrum of patients for whom the drug will be prescribed.”

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