REGULATION
The thorny path ahead on lab-developed tests
A few months ago the FDA finally made plans to regulate lab-developed tests, or LDTs, in order to improve test safety and reliability. But that's sparked controversy, and labs have launched lawsuits to challenge the agency's authority. Meanwhile, patient groups and traditional diagnostics companies support regulatory oversight in order to prevent harm from unvetted tests.
But the FDA's plans to shift policy could very easily be derailed — particularly with Donald Trump reentering the White House next month, STAT's Lizzy Lawrence writes.
"I would say there's a lot more caution in the community to wait and see what happens with litigation, the new administration, and the final rule," one diagnostics CMO told STAT.
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glp-1 drugs
Lilly's $3 billion investment in Wisconsin
To meet the incredible demand for drugs like Zepbound and Mounjaro, Eli Lilly will be infusing $3 billion into a Wisconsin manufacturing facility that it acquired earlier this year — its "single largest U.S. manufacturing investment" outside of its home base in Indiana, the company said.
The plan is to help support the need for injectables — particularly in the diabetes and obesity space. Lilly's dedicated more than $23 billion since 2020 to expand its manufacturing footprint worldwide.
The company said it'll use advanced automation like guided vehicles, robotics, and production equipment to speed medicine production. It'll add about 750 skilled jobs to the 100-ish who already work there.
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