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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 Court docket choice on abortion tablet
Biopharma leaders applauded the Supreme Court docket’s ruling yesterday that anti-abortion medical doctors didn’t have standing to problem the FDA’s regulation of the abortion tablet mifepristone.
The trade had warned {that a} choice favoring the plaintiffs might have destabilized the drug approval course of. Final 12 months, 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 carry new medication available on the market.
We checked again in with a few of these individuals after the Supreme Court docket choice yesterday:
John Maraganore, longtime biotech govt and investor: “This can be a big win for the FDA and its authorities, for science and the significance of proof over spiritual beliefs, and for girls 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 customary for drug approvals.”
Learn extra on how different trade leaders reacted.
And, in fact, FDA Commissioner Robert Califf was joyful concerning the choice. It appeared he heard about it when he obtained a name throughout a live-streamed FDA assembly (which we’ll focus on 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 skilled conferences have performed an important position for greater than 50 years in serving to regulators determine whether or not a drug or gadget deserves approval, observers say there’s room for enchancment. FDA Commissioner Robert Califf kicked off the hours-long public discourse on methods 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 therapy for Alzheimer’s illness, and Bob Langer’s most up-to-date startup.
We additionally test in with STAT’s business determinants of well being reporter, who, as a substitute of continually working at his desk, typically drives round city to purchase issues like weed, vapes, and uncooked milk — all within the title of excellent journalism.
Hear 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 large, closed its first fundraising, bringing in additional than $500 million to put money into life science startups, it announced yesterday.
J.P. Morgan had launched its life sciences personal capital group in late 2022, hiring Regeneron and Alexion Prescribed drugs cofounder Stephen Squinto to steer the group. What does the group plan to put money into? Weight problems therapies, in fact, together with therapies for cardiometabolic illness, immune-driven situations, and extra.
Notably, the group will begin and incubate new biotech firms, a mannequin that VC companies have typically struggled to execute on, Squinto informed STAT in 2022. “It’s very straightforward to put in writing a test and get an organization launched. It’s tougher to navigate the early levels of constructing an organization,” he mentioned beforehand. “I truthfully don’t suppose there are lots of companies that try this properly.”
Extra reads
- With MDMA debate spreading past biotech, Lykos CEO tries to dispel efficacy, security issues, Fierce Biotech
- Versant debuts biotech engaged on ‘anger administration for the immune system’, Biopharma Dive
- Telehealth startup Achieved’s high management arrested beneath fraud fees, STAT
- International well being chief critiques ‘ineptitude’ of U.S. response to fowl flu outbreak amongst cows, STAT
