In a high-profile decision, an FDA advisory committee voted 9–2 in early June against recommending approval for Lykos Therapeutics’s MDMA-based therapy, citing a lack of evidence to prove it works and is safe.

The drug, designed to treat post-traumatic stress disorder (PTSD), would be the first FDA-approved psychedelic therapy. It would also be the first new treatment for PTSD to receive approval in more than two decades.

An advisory committee’s recommendation is non-binding, so the drug still has a shot. The agency is set to make its final decision on August 11, leaving the public to wonder: How likely is it that Lykos’s MDMA therapy will get a nod from the FDA?

Historically, the agency tends to agree with the advisors’ recommendations. A 2019 study from New York University School of Medicine and Yale found that the FDA aligns with committee consensus about 80% of the time. Out of 376 voting meetings between 2008 and 2015, the FDA went against advisory committee recommendations 83 times, the study found.

But there have been some instances when the FDA green-lit a drug without endorsement from an advisory committee. In June 2021, for example, the agency approved Biogen’s Alzheimer’s drug Aduhelm after a panel rejected the application, citing concerns over a lack of evidence that the medicine works.

Amy Emerson, CEO of Lykos Therapeutics, told Healthcare Brew that she can’t give an estimate on the likelihood of the drug getting the green light, but she is confident “the FDA will continue to follow and evaluate the data.”

Keep reading here.—MA

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The UPGRADE tool suite from a Department of Health and Human Services agency has the chance to help hospitals improve their patch management plans, i.e., how facilities apply necessary software fixes to their (many) internet-connected devices.

One minor issue with the Universal Patching and Remediation for Autonomous Defense proposed this spring: It doesn’t exist yet.

In May, the Advanced Research Projects Agency for Health (ARPA-H) called for ideas to build “a semi-autonomous cyber-threat mitigation platform that enables proactive, scalable, and synchronized security updates, adaptable to any hospital environment, and across a wide array of the most vulnerable equipment classes.”

The core of the UPGRADE effort relies upon a digital replica, or “twin,” of a hospital’s cyber environment—a kind of “gym” for testing the effects of any proposed device changes, according to Andrew Carney, program manager at ARPA-H.

“You can move through the multiverse of modifications you might make to your network before you deploy. And then ideally, UPGRADE will assist with that deployment,” he said.

In its solicitation request, ARPA-H noted that hospital cyberattacks typically begin through IT system weaknesses.

Keep reading here.—BH

We’re listening, healthcare pros. Healthcare industry job seekers, employees, and employers have opinions. From current trends to perception gaps to real-time stats, there’s some important insight you should brush up on if you work in healthcare. Check it all out here.