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Gilead’s next test, Vijay Pande on the move, and FDA whiplash

January 13, 2026

You're back. We're sort of back. It's Day 2 of JPM, and we're definitely not exhausted or delirious yet.

This is Elaine Chen, Adam Feuerstein, Matt Herper, and Allison DeAngelis again. We've got a lot more news today, so let's get to it.

KitePharma2976-BKite Pharma

cancer

The next test for Kite Pharma — and Gilead

It's anito-cel, the CAR-T therapy for multiple myeloma that Gilead is developing in partnership with Arcellx. Gilead submitted the therapy to the FDA sometime before the end of December, Cindy Perettie, executive vice president of Kite Pharma, the cell therapy division of Gilead, told STAT at a Gilead media breakfast.

Gilead will disclose if or when the anito-cel application is formally accepted by the FDA during the first quarter, Perettie added. Given that application acceptance typically takes 60 days, the Gilead announcement could come in February. 

Why does all this matter? Because of Vinay Prasad, the FDA's top regulator of cell and gene therapies, who has had a love/hate relationship with CAR-T therapies for cancer during his previous career stint as a vocal gadfly of clinical trial design.

Not long ago, worrying about the FDA acceptance of a regulatory submission for a CAR-T therapy, especially from a company with the experience of Gilead, would have been a waste of time. Today? You never know.


WASHINGTON

Richard Pazdur, unfiltered

If you missed STAT's event last night, it's worth your time to check out what happened.

Richard Pazdur, who left the FDA only last month, took questions from Matt about what's been happening at the agency lately; his take was — shall we say — unvarnished. Among other things, Pazdur, the longtime head of the FDA's Oncology Center of Excellence and, briefly, its top drug regulator, said that the firewall between political appointees and drug reviewers at the agency "has been breached," and that there is not enough transparency around a new voucher program that grants accelerated review to certain drugs selected by Trump administration officials.

The extent of damage done at the FDA hasn't been fully realized by the biopharma industry, Pazdur said. He also noted: "The agency is only as good as the people that work there. Period. It's not the program, it's the people."

You can read coverage of the event here and watch a full video of the session with Pazdur, along with former Commissioner Scott Gottlieb and Julie Tierney, a former chief of staff at the FDA, here.



Venture capital

Vijay Pande is looking to raise some cash

Pande, the longtime investor at Andreessen Horowitz, has a new venture capital firm in the works, dubbed VZVC. He co-founded the firm with startup investor Zack Werner last year after stepping away from the bio and health team at a16z, as Andreessen is known.

Pande and Werner haven't spoken publicly about their goals, but a source told STAT that the firm could raise up to $400 million. That would be a significantly smaller pool of capital than Pande was working with at a16z, but a fairly large fund for a new firm. 

"Ten years ago, when I started the bio and health vertical at Andreessen Horowitz, talking about AI and health care was pretty radical or heretical. A lot of people thought this would never happen. … I think, now, it's become quite mainstream," he said in an interview at JPM. 

Read more.


Washington

Oz defends Medicaid cuts 

Mehmet Oz, who oversees the federal Medicare and Medicaid programs, faced some tough questions from hospital execs at an invite-only panel on JPM's sidelines. 

Speaking at the St. Francis Yacht Club, Oz downplayed the effect of President Trump's Medicaid cuts ("catastrophizing") and defended Medicaid work requirements, pointing to debunked data to claim that beneficiaries are watching TV for hours a day. He also defended the actions of his boss, RFK Jr., to curb access to vaccines.

Hospitals mostly put on a brave face at the conference itself, making a measured pitch to investors focused on stability and consistency. The execs who spoke with STAT's Tara Bannow after hearing Oz's remarks were similarly cautious. One hospital CEO told her she's focused on caring for patients.

Read more.


FDA

The latest FDA whiplash

From our colleague Damian Garde: Heading into JPM Week, investors widely expected Travere Therapeutics to win an expanded FDA approval for its kidney disease treatment on or before the agency's promised decision date today. Then, last night, Travere said it had responded to "additional information requests" from the agency, an update that reduced the company's value by nearly a third as it appeared to put approval in doubt.

In the end, Travere's drug was neither approved nor rejected but delayed, with a new decision date of April 13. That rules out "a worst-case scenario," as Leerink analyst Joseph Schwartz wrote in a note to clients, but it apparently didn't assuage investors' fears. Travere was still down about 20% after resuming trading in the afternoon.

Zooming out, Travere's experience is the latest datapoint for FDA watchers to puzzle over. The agency, whose leaders have promised flexibility and transparency, has repeatedly punted on expected approvals, leaving outsiders to sort out whether a given decision is the product of ideological changes or an overburdened workforce running out of resources.


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Thanks for reading! Come back tomorrow!

Adam, Matt, Elaine, Allison


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