December 16, 2025

The need-to-know this morning

Nektar Therapeutics reported results from a mid-stage study of its drug rezpeg in alopecia areata.

financing

Vivek Ramaswamy reemerges with startup developing pain drug

Vivek Ramaswamy — former Roivant CEO, former presidential candidate, and current Ohio gubernatorial candidate — has returned to the biotech industry with a new startup called Ambros Therapeutics.

Ambros licensed a non-opioid pain drug, neridronate, from the Italian pharmaceutical company Abiogen Pharma S.p.A. It's studying the treatment for a rare form of the chronic pain condition Complex Regional Pain Syndrome.

The FDA has prioritized the development of new pain medicines over past few years and earlier this year approved Vertex's non-opioid drug.

Read more from STAT's Allison DeAngelis.

regulation

FDA initiates priority voucher for J&J's 'Tec-Dara' combo

The FDA yesterday said it contacted Johnson & Johnson to grant the company a Commissioner's National Priority Voucher, following positive Phase 3 results of its combination treatment of Tecvayli and Darzalex for multiple myeloma.

This voucher program, introduced by Commissioner Marty Makary, pledges a one- to two-month review for selected drugs that align with the agency's national health priorities. This program has created new opportunities for some drugmakers but also stoked concerns of politicization of the FDA's decision-making.

Makary said in yesterday's announcement that within hours of J&J's results being published at the American Society of Hematology conference in early December, the agency contacted the company to discuss a voucher. "When a treatment demonstrates outstanding trial results, we have a duty to patients to move swiftly," Makary said in his statement.

The trial found that the "Tec-Dara" comboination reduced the risk of tumor progression by 83% compared to standard multi-drug treatment, achieving the study's primary efficacy goal. At three years, 83% of the patients treated with the regimen were still alive without disease worsening compared to 30% of patients in the control arms.

biotech

Who were the best CEOs in 2025?

We're almost at the end of the year, and that means it's time again for my colleague Adam Feuerstein's annual list of best biotech CEOs.

Adam, reportedly the most feared man in biotech, was uncharacteristically sunny on 2025, noting there were so many outstanding leaders, he couldn't single out just one as the best CEO of the year.

His list includes executives who facilitated major deals, like Whit Bernard and Clive Meanwell of Metsera, which was acquired by Pfizer for up to $10 billion, as well as underdogs who turned their companies around with positive data, like Abivax's Marc de Garide. He additionally calls out a notable maverick.

Read on for the other CEOs who made the list.

biotech

New analysis finds China's drug discovery output is now on par with U.S.

China's contributions to drug discovery are not only rising, but have exceeded the collective output of Europe and the rest of Asia and have gained parity with the United States, a new analysis finds.

The study, conducted by researchers at Stony Brook University and the Purdue University School of Pharmacy, looked at more than 17,000 different drugs tested in clinical settings between 2000 and 2005.

The U.S. is now like "a Ford Mustang racing against the Chinese-built BYD Yangwang U9 supercar," two of the Stony Brook researchers wrote in a new opinion piece for STAT. Federal policies, including changes to the NIH and CDC, are kneecapping American innovation at a critical moment when China's research is growing rapidly, they say.

Drug output by American sources has remained comparatively flat since 2018, while China's contributions nearly tripled in that same period, the researchers said.