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The FDA issued draft guidance that outlines steps drugmakers and device manufacturers should take to improve representation of women and people of color in clinical testing.
Stat:
FDA Issues Long-Awaited Draft Guidance For Enrolling More People Of Color In Clinical Trials
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)
Reuters:
US FDA Approves Verona Pharma's Inhaled COPD Therapy
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 —
Stat:
Journal Retracts Study Tied To Micronoma’s Cancer Blood Test
Nature retracted a high-profile paper that served as part of the scientific groundwork for Micronoma, a San Diego-based startup, on Wednesday. “Some of the findings of the article are affected and the corresponding conclusions are no longer supported,” Nature said in the retraction. (Chen, 6/26)
Boston Herald:
Alzheimer’s Research: Scientists Create AI Model To ‘Catch Alzheimer’s Disease Early’
Boston researchers say they’ve created a promising AI model that predicts the likelihood of someone developing Alzheimer’s early. The Boston University researchers on Tuesday announced that they designed the new artificial intelligence computer program — which identifies those with mild cognitive impairment who are likely to develop Alzheimer’s within six years. (Sobey, 6/26)
Bloomberg:
Startup’s Fentanyl ‘Vaccine’ Aims To Chemically Prevent High
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)
Stat:
Medicare Coverage Of Wegovy, Zepbound: New House Proposal
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)
The Boston Globe:
Moderna Headquarters Unveiled In Kendall Square
As hundreds of employees gathered in the sweltering heat Wednesday outside Moderna’s new six-floor headquarters in Kendall Square, its chief executive said consolidating dispersed employees at the new site will spur collaboration on drug discovery. “We’ve got the Cambridge team back together,” Moderna chief executive Stéphane Bancel said at the grand opening of the headquarters on 325 Binney St. “We’re going to be here on Binney Street for a very long time.” (Weisman, 6/26)
