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Morning! As we speak, we see some holes within the information for MDMA-assisted remedy, and ponder how which may influence the FDA’s upcoming determination over its approval. Additionally, the company’s advisers debate Guardant’s colon most cancers liquid biopsy check, and we see new information exhibiting Ozempic’s efficacy in stopping loss of life in diabetes and persistent kidney illness sufferers.
One programming be aware: This text is taking a vacation Monday in observance of Memorial Day. Have a superb lengthy weekend. Don’t work too exhausting.
MDMA trials don’t account for sufferers with unfavorable experiences
MDMA-assisted remedy is on the precipice of a possible FDA approval. However whereas one small examine touted an 83% response charge, that isn’t everybody. One affected person reported that she severely thought-about suicide whereas on the cellphone together with her examine therapists. “For the primary time in a extremely very long time I went, ‘I’m executed,’” she mentioned. “All that’s pounding by my head is: ‘Why am I not that 83%?’”
Incidents like these aren’t mirrored in revealed information from the trial, STAT’s Olivia Goldhill writes. However critics argue that there are inconsistencies and shortcomings within the information that might compromise the integrity of the medical trials being reviewed by the FDA.
Suicidal ideation was tracked in all research, a spokesperson for Lykos Therapeutics — the trial’s sponsor — informed STAT. But it surely wasn’t thought-about an antagonistic occasion until recorded ranges of suicidal ideation had been greater after the trial than earlier than.
Learn extra.
Ozempic cuts threat of loss of life in kind 2 diabetes, persistent kidney illness
Ozempic has racked up one other medical trial win: The Novo Nordisk blockbuster slashed the chance of loss of life in sufferers with kind 2 diabetes and persistent kidney illness by 20%. It lower cardiovascular-related deaths by 29%, and lowered the chance of main coronary heart problems by 18%. These information counsel that these GLP-1 medicine may confer benefits to sufferers over different courses of medication, STAT’s Elaine Chen writes.
Novo plans to hunt FDA approval to increase Ozempic’s utilization to deal with persistent kidney illness. Wegovy, Novo’s obesity-focused GLP-1 counterpart, lately gained approval for cardiovascular threat discount. Novo is testing Wegovy in coronary heart failure, MASH, and Alzheimer’s.
Learn extra.
Extra tumult at BIO
How does a drug trade lobbying group transfer ahead after years of upheaval, together with having 4 CEOs in 4 years?
This week on “The Readout LOUD,” STAT’s chief Washington correspondent, Rachel Cohrs Zhang, joins us to debate the layoffs at commerce group BIO and the way issues could also be altering. We additionally invite STAT reporter Eric Boodman on to speak about his new investigative sequence of tales exploring how Black girls with sickle cell illness had been coerced into getting sterilized.
Hear right here.
FDA advisers suggest Guardant’s blood-based colon most cancers check
An FDA advisory committee yesterday really useful that the company approve a blood-based colon most cancers detection check made by Guardant Well being. Of the 9 voting members, eight deemed it secure, six thought-about it efficient, and 7 believed its advantages outweighed dangers.
If regulators do approve the diagnostic, it might pave the way in which for potential protection from CMS.
In 2021, CMS declined to cowl Epi proColon, an FDA-approved, blood-based colon most cancers check made by Epigenomics, STAT’s Angus Chen and Jonathon Wosen write. Quickly after the CMS denial, the corporate mentioned it might cease advertising the check, and final yr Epigenomics introduced restructuring and layoffs.
However Defend, the check made by Guardant, is likely to be simply correct sufficient that the FDA and CMS alike will approve it.
Learn extra.
Extra reads
- Forward of ASCO, J&J stories combined information on next-generation radiopharmaceutical, STAT
- After $4B Takeda deal, Nimbus lays out ‘grand’ hopes for its next-gen immunotherapy drug, Endpoints
- Setting the desk: What to anticipate at this yr’s ASCO assembly, STAT