FDA Drug Official Steps Down, Is Sued By Drugmaker Over ‘Personal Vendetta’
George Tidmarsh left his post after a former business partner filed a complaint alleging Tidmarsh's personal animosity, through his actions and public comments, was hurting his company. Tidmarsh denies any wrongdoing. Also: Kimberly-Clark is buying embattled Tylenol maker Kenvu.
Stat:
FDA's Top Drug Regulator, George Tidmarsh, Resigns Amid Probe
George Tidmarsh, the Food and Drug Administration’s top regulator of drugs, has resigned after being accused of using his regulatory authority to inflict financial harm on a former business associate, STAT has learned. (Lawrence and Feuerstein, 11/2)
The Washington Post:
Fluoride Prescriptions To Children Restricted By FDA
Most children should not receive prescription fluoride, Food and Drug Administration officials said Friday as they announced measures to restrict sales of the cavity-fighting drug. The agency said children under 3 and older children not at high risk for tooth decay should avoid ingestible fluoride, which is often sold as tablets or drops. It sent letters to manufacturers warning them not to market the products to such children. (Roubein, 10/31)
Kimberly-Clark is buying the company that makes Tylenol —
The New York Times:
Kimberly-Clark To Buy Tylenol Maker Kenvue For $40 Billion
The owner of Kleenex and Huggies will acquire the company that has fought claims by the Trump administration that a common pain reliever is linked to harmful side effects. Shares of Kenvue have plummeted this year as U.S. health officials have claimed, without new evidence, that acetaminophen — the active ingredient in Tylenol — was linked to autism. In September, President Trump said that pregnant women should “fight like hell not to take it.” Shares of Kenvue rebounded strongly on the deal announcement, rising 20 percent in premarket trading. (Hirsch, 11/3)
In other pharma and tech developments —
Newsweek:
Walmart Expands Access To Weight-Loss Jab
From mid-November, single-dose vials of the popular weight-loss jab — Zepbound (tirzepatide) — will be available to buy from Walmart pharmacies across the U.S., thanks to a new collaboration between the retailer and pharmaceutical company Eli Lilly. According to the Centers for Disease Control and Prevention, over two in five American adults are obese. (Greenwood, 11/2)
Bloomberg:
Pfizer Sues To Block Novo Bid For Obesity Drugmaker Metsera
Pfizer Inc. sued Metsera Inc. and rival drugmaker Novo Nordisk A/S to block the Danish company’s rival bid for the obesity startup. In a statement Friday, Pfizer said the Novo offer can’t qualify as a “Superior Company Proposal” under the merger agreement, in part because it’s not likely to survive regulatory review. Pfizer is asking the Delaware Court of Chancery to block Metsera for now from closing a deal with Novo to allow Pfizer time to be heard. (Muller and Feeley, 10/31)
San Francisco Chronicle:
Methylene Blue Anti-Aging Claims Face Scientific Reality
Methylene blue, a synthetic compound once used to dye fabric, suddenly seems to be everywhere — touted by celebrities and wellness influencers and apparently used by Health Secretary Robert F. Kennedy Jr., as seen in a viral video that shows him squeezing a few drops of dark blue liquid in a glass of water. A few drops of methylene blue, many users claim, help boost energy and brain function. The compound is being studied by some longevity researchers as a potential anti-aging drug. (Ho, 11/2)
The Baltimore Sun:
Tiny Robots Could Revolutionize Medicine Within Blood Vessels
One day, robots might navigate through your blood vessels to break up clots, deliver targeted chemotherapy or repair ruptured blood vessels more efficiently and effectively than existing tools, researchers say. A soft robot catheter developed at the University of Maryland Bioinspired Advanced Manufacturing Laboratory brings these innovative treatment concepts one step closer to reality. (Hille, 10/31)
