August 24, 2026

The need-to-know this morning

A blood test from Roche that can help doctors identify Alzheimer’s disease has picked up FDA clearance. The test, called Elecsys pTau217, can determine whether someone with cognitive decline has a buildup of amyloid, a protein involved in the development of Alzheimer’s. The milestone reflects how the field has been moving to make diagnostics simpler and more accessible, including in primary care settings.
The FDA has again paused trials for Regenxbio’s gene therapy for a rare childhood brain disorder, after small masses were found on the spines of five patients.

special report

The long, winding path for the Moderna-Merck cancer vaccine

Even Moderna’s own leaders weren’t sure its personalized cancer vaccine would work. But a positive late-stage melanoma study with Merck has transformed a decade-long, often precarious experiment into what could be the first major success for the long-elusive idea of vaccinating against cancer.

The project began as a tiny Moderna unit trying to solve an almost absurd logistical problem. Researchers worked to sequence each patient’s tumor, then used an algorithm to select the mutations unique to it. From there, they manufactured a bespoke mRNA vaccine, and then got it back to the patient within weeks.

Merck eventually helped bankroll the effort, but both companies repeatedly doubted whether it would succeed — particularly as Covid disrupted the trial and drove up costs, according to a special report from STAT's Matthew Herper, Angus Chen, and Jason Mast.

Now, the question is whether this same approach can be used to develop other cancer vaccines.

"I don't think this is going to be a one-off,” said Eric H. Rubin, who led Merck’s oncology clinical development until he retired in 2023. “I think this is likely to be something that's going to be helpful for a lot of cancer patients, which is just great."

patents

FTC challenges Amgen's Enbrel patent strategy

The FTC is weighing in on an antitrust case accusing Amgen of using a patent deal to keep generic competitors of its anti-inflammatory drug Enbrel off the market.

The health insurer CareFirst alleges that Amgen acquired exclusive rights to pending patent applications, shaped them to cover the blockbuster inflammatory-disease drug, and then used the resulting patents to extend its monopoly.

Amgen argues that acquiring patent applications can’t constitute illegal monopolization. But the FTC says private deals involving pending patent applications are subject to antitrust scrutiny just like acquisitions of issued patents.

startups

Lady Gaga and her fiancé launch a biotech startup

Lady Gaga and her fiancé, Michael Polansky, have built a biotech startup called Outer Biosciences. The company, which she promoted on X the other day, is trying to speed up biological discovery by keeping real human skin alive outside the body for up to a month. The idea is that researchers can then use AI to predict promising compounds, test them on the tissue, and feed the results back into its models.

Gaga herself sits on Outer’s board, TechCrunch notes, and the startup has even collaborated with Haus Labs, her cosmetics company. Outer has raised about $23 million and currently has six active leads, mostly cosmetic ingredients it hopes to license to beauty or pharma companies.

Artificial intelligence

FDA readies rules for generative AI devices

The FDA is developing formal guidance for medical devices powered by generative AI, STAT’s Mario Aguilar reports exclusively. This includes not just broad, formal policy guidance, but more more targeted rules for particularly complex use cases, the director of the agency's Digital Health Center of Excellence, Rick Abramson, told STAT.

The agency is considering a “competency-based” framework modeled loosely on how doctors are credentialed: Rather than testing a device on every possible scenario, FDA could benchmark it, clinically confirm how it performs, and continue monitoring it after it’s in use. This could help the agency tolerate uncertainty before a product’s approved in exchange for stronger postmarket oversight.

drug pricing

Medicaid's transgender health rule could have broader coverage implications

The Trump administration’s new restrictions on Medicaid covering gender-affirming care could have implications far beyond transgender health, STAT’s John Wilkerson writes. A new CMS rule prevents federal Medicaid and CHIP dollars from paying for pediatric gender-affirming drugs and surgery, even though this isn’t a category Congress allows states to exclude from Medicaid coverage.

“They are sort of ignoring congressional intent on these provisions that just happen to be inconvenient to their policy agenda,” Edwin Park, a researcher at Georgetown University who focuses on Medicaid, told STAT.

This approach could potentially be used to restrict coverage of other medications. The rule takes effect Oct. 13 and is expected to face legal challenges.

Thanks for reading! Until tomorrow,