J.P. Morgan, mifepristone, Cabaletta Bio news
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Good morning. We’ve made it to the tip of the week! Let’s preserve it brief and get straight to the information of the day.
The necessity-to-know this morning
- Cabaletta Bio presented early data on an experimental CD-19 focusing on CAR-T remedy for autoimmune illness at a European rheumatology assembly.
Business cheers Supreme Courtroom choice on abortion capsule
Biopharma leaders applauded the Supreme Courtroom’s ruling yesterday that anti-abortion medical doctors didn’t have standing to problem the FDA’s regulation of the abortion capsule mifepristone.
The trade had warned {that a} choice favoring the plaintiffs may have destabilized the drug approval course of. Final yr, after a federal decide in Texas suspended the FDA’s approval of mifepristone, a whole bunch of biopharma executives and leaders signed onto an open letter blasting the choice, saying that it created uncertainty for the complete trade, which depends on the company’s autonomy and authority to deliver new medicine in the marketplace.
We checked again in with a few of these folks after the Supreme Courtroom choice yesterday:
John Maraganore, longtime biotech government and investor: “It is a big win for the FDA and its authorities, for science and the significance of proof over spiritual beliefs, and for ladies and their rights. Thank God!”
Daphne Zohar, Seaport Therapeutics CEO: The “choice ensures sufferers and drug builders can depend on the rigorous FDA approval course of because the scientific and trusted commonplace for drug approvals.”
Learn extra on how different trade leaders reacted.
And, after all, FDA Commissioner Robert Califf was blissful concerning the choice. It appeared he heard about it when he acquired a name throughout a live-streamed FDA assembly (which we’ll talk about beneath): “All proper! How are you! We bought excellent news,” he exclaimed.
FDA will get sharp advisory committee critiques
From STAT’s Meghana Keshavan: It was all a bit meta — yesterday, the FDA convened what was primarily an advisory committee to upend advisory committees. Though these professional conferences have performed an important position for greater than 50 years in serving to regulators determine whether or not a drug or machine deserves approval, observers say there’s room for enchancment. FDA Commissioner Robert Califf kicked off the hours-long public discourse on learn how to make these committees higher.
Advocates spoke passionately about how affected person voices should be higher heard, and higher represented, throughout these panels. And there’s long-standing fear that conflicts of curiosity are rampant amongst committee members.
Learn extra.
Duchenne remedy setback, an Alzheimer’s drug endorsement, and shopping for weed for journalism
This week on the “The Readout LOUD,” we chat about Pfizer’s Duchenne gene remedy setback, the probably approval of Lilly’s remedy for Alzheimer’s illness, and Bob Langer’s most up-to-date startup.
We additionally verify in with STAT’s industrial determinants of well being reporter, who, as an alternative of continually working at his desk, typically drives round city to purchase issues like weed, vapes, and uncooked milk — all within the identify of fine journalism.
Pay attention right here.
J.P. Morgan has formally jumped into early stage biotech investing
From STAT’s Allison DeAngelis: J.P. Morgan Life Sciences Non-public Capital, a small group throughout the funding banking big, closed its first fundraising, bringing in additional than $500 million to spend money on life science startups, it announced yesterday.
J.P. Morgan had launched its life sciences personal capital group in late 2022, hiring Regeneron and Alexion Prescription drugs cofounder Stephen Squinto to steer the group. What does the group plan to spend money on? Weight problems therapies, after all, together with therapies for cardiometabolic illness, immune-driven situations, and extra.
Notably, the group will begin and incubate new biotech corporations, a mannequin that VC corporations have typically struggled to execute on, Squinto advised STAT in 2022. “It’s very simple to write down a verify and get an organization launched. It’s tougher to navigate the early phases of constructing an organization,” he mentioned beforehand. “I actually don’t suppose there are lots of corporations that try this effectively.”
Extra reads
- With MDMA debate spreading past biotech, Lykos CEO tries to dispel efficacy, security considerations, Fierce Biotech
- Versant debuts biotech engaged on ‘anger administration for the immune system’, Biopharma Dive
- Telehealth startup Achieved’s high management arrested underneath fraud fees, STAT
- International well being chief critiques ‘ineptitude’ of U.S. response to chook flu outbreak amongst cows, STAT
