Drugs

Progress Seen in Sex-Inclusive Research

Academic researchers from Northwestern University and Smith College say the number of sex-inclusive research studies has significantly increased across most biological disciplines since the National Institutes of Health implemented a 2016 policy requiring investigators to consider sex as a biological variable. Writing in eLife, the researchers say while their review indicates progress, in eight of the disciplines there was no change in the proportion of studies that included data analyzed by sex.

“The majority of studies failed to provide a rationale for single-sex studies or the lack of sex-based analyses, and those that did relied on misconceptions surrounding the hormonal variability of females,” the authors write. “Together, these data demonstrate that while sex-inclusive research practices are more commonplace, there are still gaps in analyses and reporting of data by sex in many biological disciplines.”

The authors say their results highlight a continued need for education, awareness, and advocacy surrounding sex-based research practices including the consideration of sex as a biological variable. “We call upon academic publishers to require a description of sex, rationale for single-sex studies or lack of sex-based analyses in the experimental methods,” they conclude. “In the absence of formal policies, reviewers can ask for these essential criteria. In addition, funders can also contribute to the advancement of rigorous sex-inclusive science by requiring grant proposals to include appropriate sex-based reporting and analyses and determine funding success on the evaluation of sex and other key biological variables.”

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