Eli Lilly, Pfizer, Interius, UniQure latest
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Good morning. STAT revealed an investigation this morning on the untold story of the Human Genome Undertaking and ethics considerations surrounding the bold mission. Test it out right here.
The necessity-to-know this morning
- Pfizer Chief Scientific Officer and R&D Chief Mikael Dolsten is leaving the company after 15 years. A seek for his successor is predicted to final till early subsequent yr, the pharma big mentioned.
- UniQure mentioned its experimental gene remedy known as AMT-130 slowed the progression of Huntington’s disease by 80% in comparison with an exterior management group in a mid-stage medical trial.
Interius to begin first ever in-vivo CAR-T medical trial
Interius Biotherapeutics will quickly start the world’s first medical trial of in-vivo CAR-T remedy. Sufferers will obtain an IV infusion designed to rework their immune cells into most cancers killers inside their our bodies.
Conventional CAR-T remedy is “ex-vivo,” which means the immune cells are manipulated outdoors the physique. It’s an advanced and costly course of that includes extracting the cells from the affected person, delivery them to a specialised facility to be labored on, after which reinfusing the cells again into the affected person.
Conventional CAR-T is out of attain for a lot of sufferers, and researchers hope that the brand new in-vivo strategy may present a less expensive and extra scalable choice.
Learn extra from STAT’s Jason Mast.
Pharma is dropping pals on Capitol Hill
Pharma’s place in Washington has already been weakening over the previous few years, as underscored by the passage of the Inflation Discount Act, which allowed Medicare to barter drug costs. The business’s affect is about to wane much more as a few of its closest allies depart Capitol Hill.
My colleague Rachel Cohrs Zhang stories that no less than six key pharma-friendly lawmakers are anticipated to have left their seats by the start of subsequent yr, and their doubtless replacements are much less pleasant to the business and fewer desirous about well being care.
One instance is Sen. Bob Menendez of New Jersey, residence of pharma giants Johnson & Johnson, Merck, and Bristol Myers Squibb. Menendez is presently on trial for bribery prices, and the Democrat vying to switch him, Rep. Andy Kim, helps the social gathering’s extra bold drug pricing plans.
Learn extra on the opposite allies pharma can be dropping.
Lilly’s weight problems drug appears stronger than Novo’s in observational examine
In its pivotal Section 3 trial, Eli Lilly’s tirzepatide (offered as Mounjaro/Zepbound) led to extra weight reduction than what was seen within the trial of Novo Nordisk’s semaglutide (offered as Ozempic/Wegovy). It’s been laborious to straight evaluate the 2 medication, although, since there haven’t but been outcomes from any head-to-head trials, however a brand new observational examine suggests Lilly’s drug could certainly result in higher weight reduction.
The examine, published yesterday in JAMA Internal Medicine, analyzed the well being data of over 18,000 individuals and located that these on tirzepatide had about 15% weight reduction at one yr, whereas these on semaglutide had about 8%. Moreover, 42% of sufferers on tirzepatide achieved greater than 15% weight reduction, in contrast with 18% of sufferers on semaglutide.
Because it’s a retrospective observational examine, there are numerous limitations. For instance, sufferers could have encountered shortages and will not have been capable of persistently take their drugs. Sufferers could have additionally been on totally different diets and train regimens.
We’ll be waiting for outcomes of a randomized head-to-head trial that Lilly is working that’s anticipated to finish in November this yr.
A non-public fairness strategy to investing in neuro medication
Traders have lengthy been reluctant to put money into drug applications for neurological issues. There’s been a historical past of failed research and lots of trial endpoints are subjective and tough to measure.
Bruce Leuchter, CEO of Neurvati Neurosciences, a Blackstone Life Sciences portfolio firm, argues in a brand new opinion piece that buyers ought to undertake a a “non-public fairness mannequin” to put money into neurology drug candidates.
This implies taking a look at molecules later within the growth lifecycle quite than at early-stage medication that the traditional enterprise mannequin focuses on. Whereas the prices to amass a later-stage drug can be increased, buyers would be capable of higher vet this system and make sure the rationale behind the drug’s mechanism, Leuchter writes.
Learn extra.
Extra reads
- When can pharma firms appropriate on-line misinformation? FDA explains, Endpoints
- AI leads the way in which as well being tech funding inches towards a post-pandemic stability, STAT
- Trump’s 2024 platform abandons calls to chop Medicare, broadly limit abortion, STAT
- New examine sparks debate about whether or not H5N1 virus in cows is customized to higher infect people, STAT