Health

Rocket Pharma, MDMA therapy, Medicare bill

Published

2 days ago

June 30, 2024

Rocket Pharma, MDMA therapy, Medicare bill

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Morning! Today we discuss how a House committee voted overwhelmingly in favor of four health care bills. There’s also still reason to believe that MDMA-assisted therapy could win FDA approval and more.

The must-know this morning

The FDA turned down Rocket Pharma’s gene therapy for severe leukocyte adhesion deficiency-I, a rare, sometimes fatal immunodeficiency syndrome. The company said the agency was experiencing production issues.
Apellis said that CHMP, the medicines evaluation arm of the European Medicines Agency, recommended against approving Empaveli, the injectable product for geographic atrophy. Apellis said it plans to appeal.
CHMP also advised in return for approved an ALS drug and again recommended that the EMA not renew the authorization for Translarna, a controversial drug for Duchenne muscular dystrophy.
The long Covid process of a small Swiss biotech failedwhich leads to layoffs.

The House of Representatives committee passes four health bills

The House Ways & Means Committee just passed four major federal health care reimbursement bills. This included new legislation that would expand Medicare coverage of obesity drugs, which has been prohibited until now. However, the bill would only cover certain obesity patients: It would pay for patients who were taking weight-loss medications before switching to Medicare.

A separate bill would allow Medicare to pay for healthy people to undergo blood tests for cancer screening. Galleri, a multicancer test, has a list price of about $950; the bill would allow Medicare to pay $508 for such tests.

The committee also voted in favor of a bill aimed at Medicare coverage of breakthrough medical devices, and unanimously approved another bill that would force Medicare to reconsider special coverage decisions after ten years.

Why MDMA-assisted therapy could still gain approval

Despite an advisory committee overwhelmingly rejecting a bid by Lykos Therapeutics to use MDMA as a treatment for PTSD, founder Rick Doblin has remained optimistic. At a recent psychedelics conference, he said he believed there was “substantially more than a 50/50 chance” that the FDA would approve the psychedelic.

Doblin and other psychedelics evangelists have been working since the 1980s to convince regulators that this treatment modality is effective. The decades of work could finally pay off — and Lykos could very well win approval for its MDMA-based treatment this summer, STAT’s Olivia Goldhill writes.

The important health issues this election season

Will Medicare finally start covering weight loss medications like Zepbound and Wegovy? And what health care issues could be a lightning rod in this election?

STAT Chief Washington Correspondent Rachel Cohrs Zhang joins the podcast to talk about a new proposal for obesity drug coverage in Washington and what to expect from the first presidential debate. STAT health tech reporter Brittany Trang is also this week’s guest host of “The Readout LOUD,” where we discuss AI for drug development, the latest news on the H5N1 avian flu outbreak, a surprise entrant to the GLP-1 field, and more news in the life sciences.

Listen.

Controlling these biotech supply chains

America’s ability to remain at the top of the biotech industry will depend on its ability to protect genomic data and intellectual property, says Josh Carpenter, CEO of a nonprofit translational research institute focused on drug discovery and genomic research . These are the crucial tools in developing more advanced precision medicine in an increasingly complex international market.

“China poses a threat to both securing genomic data and protecting intellectual property,” he writes. “This misappropriation of genomic data and carelessness with IP underscores the need for strong protections against entities that pose such risks.”