FDA's new CDER chief eyes SSRIs, RSV

In her first address to CDER staff, acting director Tracy Beth Høeg signaled yesterday that two long-standing areas of her interest — SSRI antidepressants in pregnancy and RSV monoclonal antibodies that protect infants — are now squarely on the drug center's agenda.

She said the agency hasn't done enough "thorough safety monitoring" of antidepressants during pregnancy, STAT's Lizzy Lawrence reports exclusively, and called for more randomized data in pregnant populations, framing a fetus as "a very small child."

She also questioned the safety profile of RSV monoclonals, flagging deaths in trials deemed unrelated to the products and raising the specter of seizure risk despite CDC data finding no such safety signal. Høeg, who quoted Ayn Rand according to a recording obtained by STAT, urged staff to "question the norms."

Høeg, the fifth person to lead CDER since the start of last year, took over the center after Richard Pazdur's retirement, and amid internal unease about politicization in the drug approval process.

cancer

Grail's Galleri blood test fails major NHS cancer study

Grail's long-touted Galleri blood test for multi-cancer early detection just failed to hit its primary endpoint in a massive 142,000-person NHS trial that was supposed to quiet skeptics. The goal was to catch cancers earlier so fewer patients present with stage IV disease — and statistically, it simply didn't get there, STAT's Matthew Herper writes.

Grail is now leaning on what it calls a "favorable trend" — that is, a not-quite-statistically-significant result — in that it tracked a reduction in stage IV diagnoses within a pre-specified subset of patients with 12 high-mortality cancers.

But as Scripps Research Translational Institute director and founder Eric Topol bluntly put it, giant trials with this kind of power aren't graded so obliquely: "There's no such thing in clincial trials as a faorable trend, especially in a trial that has got immense statistical power," he said.

Investors noticed — shares plunged nearly 50% after hours.

DIGITAL HEALTH

FDA's new AI gatekeeper has industry roots

The FDA has installed Rick Abramson, a former chief medical officer at a health AI company, as director of its Digital Health Center of Excellence. It's a consequential pick, since the agency is currently recalibrating how aggressively it intends to regulate clinical AI, STAT's Mario Aguilar and Lizzy Lawrence write.

Abramson, who was chief medical officer of a subsidiary of Harrison.ai that develops AI products to interpret radiological images, has been advising the commissioner's office since last summer. He was reportedly part of the internal push to soften oversight of clinician-support AI and allow more wellness tools to sidestep review.

As he steps into the role, the FDA is weighing a petition from Harrison.ai that would let certain AI devices bypass premarket review.

GENETICS

Element Biosciences launches table-top sequencer capable of $100 genome

From my colleague Jonathan Wosen: Genomics startup Element Biosciences yesterday announced the launch of VITARI, a sequencer small enough to fit on a laboratory benchtop but capable of decoding large amounts of genomic information. The instrument, which will be sold for $689,000 starting in the second half of this year, can read a human genome for $100 when run at full capacity, returning results in around 36 hours.

In an interview with STAT, CEO Molly He described the launch as an effort to make sequencing more accessible to labs that don't have the space or resources for larger and more expensive high-throughput machines.

Element is looking to compete with fellow San Diego firm Illumina, a genomics juggernaut that controls about 80% of the current market. (The startup, started by Illumina veterans, is locked in an ongoing patent infringement suit with Illumina.)

In a note to investors, market analyst Puneet Souda wrote that VITARI's launch likely doesn't pose an immediate competitive risk for Illumina's high-end sequencers but could draw interest from smaller labs that aren't already Illumina customers.

podcast

Hims' Super Bowl fallout, and the FDA reverses course

Was Hims' Super Bowl ad the final straw for regulators? Is the bar being lowered for psychedelic medicines? And what's happening behind-the-scenes with Moderna and the Food and Drug Administration?

We discuss all that on this week's episode of "The Readout LOUD." STAT's Katie Palmer joins Adam, Elaine, and Allison to discuss the Hims GLP-1 pill fallout. The hosts also discuss the latest on Moderna's influenza vaccine application and Compass Pathways' depression psychedelic data.

Listen here.

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