Rocket Pharma, MDMA therapy, Medicare bill
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Morning! Right this moment, we talk about how a Home committee has overwhelmingly voted in help of 4 health-related payments. Additionally, there’s nonetheless motive to consider that MDMA-assisted remedy might win FDA approval, and extra.
The necessity-to-know this morning
- The FDA rejected Rocket Pharma’s gene remedy for extreme leukocyte adhesion deficiency-I, a uncommon, generally deadly immunodeficiency syndrome. The corporate mentioned the company had manufacturing considerations.
- Apellis mentioned CHMP, the drug-reviewing arm of the European Medicines Company, recommended in opposition to approving Empaveli, its injectable for geographic atrophy. Apellis mentioned it plans to attraction.
- CHMP additionally really helpful against approving an ALS drug and as soon as once more really helpful the EMA not renew authorization for Translarna, a controversial Duchenne muscular dystrophy drug.
- A tiny Swiss biotech’s lengthy Covid trial failed, triggering layoffs.
Home committee passes 4 well being payments
The Home Methods & Means Committee simply handed 4 essential federal well being reimbursement payments. Amongst them was new laws that may develop Medicare protection of weight problems medicine, which till now has been prohibited. The invoice would solely cowl sure of weight problems sufferers, nonetheless — paying for sufferers who had been taking weight reduction medicine earlier than transitioning to Medicare.
A separate invoice would permit Medicare to pay for wholesome individuals to take most cancers screening blood exams. Galleri, a multi-cancer check, has a listing worth of about $950; the invoice would permit Medicare to pay $508 for such exams.
The committee additionally voted in favor of a invoice centered on Medicare protection of breakthrough medical gadgets, and unanimously handed one other that may drive Medicare to rethink particular protection selections after 10 years.
Learn extra.
Why MDMA-assisted remedy nonetheless would possibly win approval
Regardless of an advisory committee overwhelmingly rejecting a bid from Lykos Therapeutics to make use of MDMA as a therapy for PTSD, founder Rick Doblin has remained optimistic. At a latest psychedelics convention, he mentioned he believed there was “considerably greater than a 50/50 likelihood” that the FDA would approve the psychedelic.
Doblin and different psychedelics evangelists have been engaged on persuading regulators for the reason that Eighties that this therapy modality is efficient. The a long time of labor might in the end repay — and Lykos very properly may even see an approval this summer season for its MDMA-based therapy, STAT’s Olivia Goldhill writes.
Learn extra.
The essential well being points this election season
Will Medicare lastly start protecting weight reduction medicine like Zepbound and Wegovy? And what well being care points could also be lightening rods on this election?
STAT chief Washington correspondent Rachel Cohrs Zhang joins the podcast to speak a few new proposal for weight problems drug protection in Washington and what to anticipate from the primary presidential debate. STAT well being tech reporter Brittany Trang additionally visitor co-hosts “The Readout LOUD” this week, the place we talk about AI for drug improvement, the most recent within the H5N1 hen flu outbreak, a shock entrant to the GLP-1 area, and extra information within the life sciences.
Pay attention right here.
Controlling these biotech provide chains
America’s potential to remain on prime of the biotech business will rely upon its potential to guard genomic knowledge and mental property, opines Josh Carpenter, CEO of a nonprofit translational analysis institute centered on drug discovery and genomic analysis. These are the important instruments in creating extra superior precision medication in an more and more complicated worldwide market.
“China poses a risk to each securing genomic knowledge and defending mental property,” he writes. “This misappropriation of genomic knowledge and fecklessness with IP underscores the necessity for stringent protections from entities that pose such dangers.”
Learn extra.
Extra reads
- Making an attempt to outrun her prion illness, researcher creates highly effective epigenetic editor in mice, STAT
- Supreme Court docket rejects the controversial Purdue chapter plan, STAT
- Spain’s Rovi receives presents for potential sale of €2B-plus CDMO group, FiercePharma
