politics
Makary dropped by BIO, too
From my colleague Elizabeth Cooney: FDA Commissioner Marty Makary gave vaccines a vote of confidence and applauded regulatory methods that speed drug approvals to a receptive crowd at the BIO conference yesterday.
“Vaccines save lives,” he said. “Any case of a vaccine-preventable illness is a tragedy. We want to continue to encourage innovation in the vaccine space.”
As for existing Covid boosters, he said he leans toward European standards for who should get them, disparaging what he called any approach “based on a theory that every 12-year-old healthy child in America needs another 60 doses for the rest of their life, one every year.”
While highlighting the FDA’s established accelerated approval program and new pilot for priority vouchers, he advocated for being creative in the way medications are evaluated.
“We have to build on the success of many of these pathways. Talk to anybody who has benefited from a drug with the acceleration pathway, or rapid review designation, or the priority review voucher program,” he said. “Ask anybody who has benefited on the ground, do you think we should postpone the release a couple more years?"
A version of this item also appeared in STAT's BIO in 30 seconds newsletter. Sign up here to get the daily news coming out of the ongoing BIO conference.
biotech
Psychedelics proponents see hope for acceptance in the Trump administration
There's growing enthusiasm and momentum in the psychedelics field again, as companies and investors view many officials in the Trump administration as critical allies, my colleagues report.
Health secretary RFK Jr. has voiced support for psychedelics as a potential mental health treatment, and White House adviser Calley Means has written that psychedelics “should be an important public policy priority for the United States.”
The renewed hope is a boost for the field, which suffered a setback last year when the FDA rejected a company’s application to use MDMA as part of a treatment protocol for post-traumatic stress disorder.
Read more from STAT's Olivia Goldhill and Meghana Keshavan.
biotech
New neuro company raises $140M for depression drug
From my colleague Drew Joseph: A new neuropsychiatry-focused company launched today, saying it raised has raised $140 million as it pursues a treatment for major depressive disorder.
The company, called Draig Therapeutics, was created through a collaboration between Cardiff University's Medicines Discovery Institute and SV Health Investors. Other backers of the company include Access Biotechnology, Canaan Partners, SR One, Sanofi Ventures, Schroders Capital, and ICG. Ruth McKernan, an operating partner at SV and founder of Draig, is serving as interim CEO as the team seeks out a permanent leader.
The firm is based off research by two scientists at Cardiff, John Atack and Simon Ward. It's already tested its lead candidate, called DT-101, in a Phase 1 study in major depressive disorder, and the new funding will allow Draig to push the drug into Phase 2 trials. The company has two other compounds that it says could go into clinical development next year that have “potential across a range of prevalent and underserved neuropsychiatric disorders.”
