June 14, 2024

The need-to-know this morning

Cabaletta Bio presented early data on an experimental CD-19 targeting CAR-T therapy for autoimmune disease at a European rheumatology meeting.

biotech

Industry cheers Supreme Court decision on abortion pill

Biopharma leaders applauded the Supreme Court's ruling yesterday that anti-abortion doctors did not have standing to challenge the FDA's regulation of the abortion pill mifepristone.

The industry had warned that a decision favoring the plaintiffs could have destabilized the drug approval process. Last year, after a federal judge in Texas suspended the FDA's approval of mifepristone, hundreds of biopharma executives and leaders signed onto an open letter blasting the decision, saying that it created uncertainty for the entire industry, which relies on the agency's autonomy and authority to bring new drugs on the market.

We checked back in with some of these people after the Supreme Court decision yesterday:

John Maraganore, longtime biotech executive and investor: "This is a huge win for the FDA and its authorities, for science and the importance of evidence over religious beliefs, and for women and their rights. Thank God!"

Daphne Zohar, Seaport Therapeutics CEO: The "decision ensures patients and drug developers can rely on the rigorous FDA approval process as the scientific and trusted standard for drug approvals."

Read more on how other industry leaders reacted.

And, of course, FDA Commissioner Robert Califf was happy about the decision. It appeared he heard about it when he received a call during a live-streamed FDA meeting (which we'll discuss below): "All right! How are you! We got good news," he exclaimed.

regulation

FDA gets sharp advisory committee critiques

From STAT's Meghana Keshavan: It was all a bit meta — yesterday, the FDA convened what was essentially an advisory committee to upend advisory committees. Although these expert meetings have played a crucial role for more than 50 years in helping regulators decide whether a drug or device merits approval, observers say there's room for improvement. FDA Commissioner Robert Califf kicked off the hours-long public discourse on how to make these committees better.

Advocates spoke passionately about how patient voices need to be better heard, and better represented, during these panels. And there's long-standing worry that conflicts of interest are rampant among committee members.

podcast

Duchenne therapy setback, an Alzheimer's drug endorsement, and buying weed for journalism

This week on the "The Readout LOUD," we chat about Pfizer's Duchenne gene therapy setback, the likely approval of Lilly's treatment for Alzheimer's disease, and Bob Langer's most recent startup.

We also check in with STAT's commercial determinants of health reporter, who, instead of constantly working at his desk, often drives around town to buy things like weed, vapes, and raw milk — all in the name of good journalism.

Listen here.

financing

J.P. Morgan has officially jumped into early stage biotech investing

From STAT's Allison DeAngelis: J.P. Morgan Life Sciences Private Capital, a small team within the investment banking giant, closed its first fundraising, bringing in more than $500 million to invest in life science startups, it announced yesterday.

J.P. Morgan had launched its life sciences private capital team in late 2022, hiring Regeneron and Alexion Pharmaceuticals cofounder Stephen Squinto to lead the group. What does the team plan to invest in? Obesity therapies, of course, along with treatments for cardiometabolic disease, immune-driven conditions, and more.

Notably, the group will start and incubate new biotech companies, a model that VC firms have generally struggled to execute on, Squinto told STAT in 2022. "It's very easy to write a check and get a company launched. It's harder to navigate the early stages of building a company," he said previously. "I honestly don't think there are many firms that do that well."

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