FDA proposes setting a bar for weight-loss therapies; exposure to aircraft noise and heart function; Athira Pharma Inc. pays $4 million to settle false claims allegation – Morning Medical Update

Author(s):

Austin Littrell

Key Takeaways

FDA's draft guidance recommends a minimum 5% weight loss for investigational obesity therapies to establish efficacy.
Aircraft noise exposure is associated with stiffer heart muscles and increased risk of major cardiac events.
Athira Pharma Inc. settles for $4 million over allegations of not reporting research misconduct in NIH and HHS grant applications.

The top news stories in medicine today.

FDA proposes setting a bar for weight-loss therapies

In a draft guidance released to the public for comment on Tuesday, the U.S. Food and Drug Administration (FDA) set out efficacy standards for investigational obesity therapies, recommending a minimum of 5% weight-loss for drug developers intent on establishing the efficacy of their investigational obesity candidates. Under the guidance, a drug candidate would be considered effective for long-term weight loss and management if it is able to demonstrate at least a 5% decrease in body weight compared to the control after one year of treatment. BioSpace has more here, and you can find the FDA draft guidance here.

Exposure to aircraft noise linked to worse heart function

A new study led by University College London (UCL) researchers and published in the Journal of the American College of Cardiology (JACC), found that people who live close to airports could be at greater risk of poor heart function. According to the study, individuals living in areas with higher-than-recommended aircraft noise levels had “stiffer and thicker heart muscles.” Their heart muscles had more difficulty contracting and expanding and were less efficient at pumping blood around the body. Researchers found that people living in these conditions could have double to quadruple the risk of major cardiac events, including heart attack, life-threatening heart rhythms or stroke, when compared to people without these abnormalities.

Athira Pharma Inc. agrees to pay $4 million to settle false claims allegation

Athira Pharma Inc. has agreed to pay $4,068,698 to settle allegations that it violated the False Claims Act (FCA) by failing to report allegations of research misconduct to the National Institutes of Health (NIH) and Department of Health and Human Services (HHS) Office of Research Integrity in grant applications and grant award progress reports.