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Thursday, Jun 27 2024

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FDA's Late Guidance Tackles Lack Of Diversity In Clinical Trials

The FDA issued draft guidance that outlines steps drugmakers and device manufacturers should take to improve representation of women and people of color in clinical testing.

The Food and Drug Administration has drafted guidance aimed at getting drug companies and medical device makers to enroll more people of color and women in the clinical trials that test whether products work. (Wilkerson, 6/26)

The U.S. Food and Drug Administration has granted approval to a treatment from Verona Pharma for a chronic lung disease that commonly affects smokers, the U.K.-based company said on Wednesday. (Jain and Chari, 6/26)

In other pharma and tech news 鈥

Nature retracted a high-profile paper that served as part of the scientific groundwork for Micronoma, a San Diego-based startup, on Wednesday. 鈥淪ome of the findings of the article are affected and the corresponding conclusions are no longer supported,鈥 Nature said in the retraction. (Chen, 6/26)

Boston researchers say they鈥檝e created a promising AI model that predicts the likelihood of someone developing Alzheimer鈥檚 early. The Boston University researchers on Tuesday announced that they designed the new artificial intelligence computer program 鈥 which identifies those with mild cognitive impairment who are likely to develop Alzheimer鈥檚 within six years. (Sobey, 6/26)

A new startup called Ovax Inc. has raised $10 million to develop a vaccine to prevent fentanyl deaths, aiming to commercialize academic research that prevents the drug from reaching the brain. The startup has licensed intellectual property from researchers at the University of Houston who have successfully tested a fentanyl vaccine in rats. Ovax, which officially launches this week, plans to begin the first human trials of the vaccine early next year. If successful, the vaccine will block users of fentanyl from getting high or overdosing from the drug. (Chapman and Langreth, 6/26)

As weight loss medications have exploded in popularity, a bill to allow Medicare to cover the drugs has languished virtually unchanged in Congress for a decade. Until now. (Zhang, 6/26)

As hundreds of employees gathered in the sweltering heat Wednesday outside Moderna鈥檚 new six-floor headquarters in Kendall Square, its chief executive said consolidating dispersed employees at the new site will spur collaboration on drug discovery. 鈥淲e鈥檝e got the Cambridge team back together,鈥 Moderna chief executive St茅phane Bancel said at the grand opening of the headquarters on 325 Binney St. 鈥淲e鈥檙e going to be here on Binney Street for a very long time.鈥 (Weisman, 6/26)

This is part of the Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.
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