Today, a brief rundown of news from the Food and Drug Administration and Kenvue, as well as updates from Moderna, Eli Lilly and AAVantgarde that you may have missed.
George Tidmarsh, the head of one of the Food and Drug Administration’s principal drug review office, has resigned amid an investigation by federal officials into “serious concerns about his personal conduct,” according to multiple published reports. Tidmarsh was appointed in July to run the Center for Drug Evaluation and Research and, along the way, publicly criticized — in unusual fashion — a marketed drug from Aurinia Pharmaceuticals. According to reporting from STAT and the Associated Press, the episode triggered a lawsuit from Aurinia alleging Tidmarsh had been using his post to enact a “personal vendetta” against the company’s board chair, Kevin Tang, who was involved in Tidmarsh’s exit from La Jolla Pharmaceuticals years ago. — Ben Fidler
Kimberly-Clarke has agreed to acquire Kenvue in a cash-and-stock deal that values the former consumer health division of Johnson & Johnson at about $48.7 billion. The deal creates a personal care company with 10 billion-dollar brands, among them Huggies diapers and the over-the-counter medications Tylenol and Zyrtec. Kenvue went public in a $3.8 billion initial public offering in 2023. But it’s had a turbulent run of late, as activist investors have pushed the company to sell itself and it’s been targeted in lawsuits since President Trump alleged, without clear evidence, that the active ingredient in Tylenol is linked to autism. — Ben Fidler
Moderna said Monday it has dosed its first patient in an early stage trial evaluating an experimental T-cell engager in people with relapsed or refractory multiple myeloma. The company has seen its share price cut in half over the last year following several research setbacks, flagging COVID-19 vaccine sales and policy shifts affecting vaccine and messenger RNA research. The drug, known as mRNA-2808, is part of an effort to branch out into oncology and the first T-cell engager it’s brought to human testing. — Delilah Alvarado
Eli Lilly will build a new $3 billion facility in the Netherlands designed to help boost its capacity to produce oral medicines. That site will also be among the facilities manufacturing orforglipron, the diabetes and weight loss pill Lilly soon aims to submit for regulatory approval. The plant will bring 500 jobs to the region and another 1,500 during construction, which is expected to begin next year. Lilly has four production facilities in Europe and has shared plans for three others since 2020. — Ben Fidler
Gene therapy startup AAVantgarde Bio said Monday it closed on a $141 million Series B financing round. The funds will be used to complete early-stage trials the company is running in two inherited eye diseases, Stargardt disease and Usher syndrome 1B, as well s a natural history study in people with Stargardt. The funding was co-led by new investor Schroders Capital along with existing backers Atlas Venture and Forbion, which co-led the company’s Series A round in 2023. — Delilah Alvarado
