We’re reading about Amgen data controversy, J&J suing the feds

Hello, everyone, and how are you today? We are doing just fine, thank you, especially since the middle of the week is upon us. Hang on tight and the weekend will be here in no time. Moreover, we are enjoying clear blue skies and pleasant breezes, so what better way to celebrate than with another cup of stimulation. Our choice today is pistachio creme. Repeat after me: Yummy. As always, you are invited to join us. Meanwhile, here are a few tidbits to help you pass the time. We hope your day is simply smashing and you conquer the world. And of course, do keep in touch. We get lonely easily. …

A tiny shred of data on Amgen’s lead obesity candidate — not yet verified — erased $12 billion in market value on Tuesday, STAT explains. The data, spotted by an analyst at Cantor Fitzgerald, focused on concerns about potential side effects with the drug, called MariTide. Once they were shared widely in an investor note, the company’s shares fell 7%, a reminder that its stock is in a highly precarious position ahead of a critical readout of the therapy. Analyst Olivia Brayer found the data, which were previously unreported, in hidden tabs of a file attached to the publication of early trial results for MariTide. The hidden tabs contained what appeared to be results showing study participants experiencing loss of bone mineral density, especially among those in the group taking the highest doses of the drug, according to Brayer. Amgen subsequently maintained there was no link between its experimental weight-loss drug and changes in bone density, according to Reuters. Four other analysts said the concerns were overblown, especially considering the company was conducting a mid-stage study and planned to invest in a larger late-stage trial as well.

U.S. Food and Drug Administration Commissioner Robert Califf is unsure about the future of the agency under the incoming Trump administration and “disappointed” about the outcome of the election, STAT says. The ability to hire and retain skilled employees may be in jeopardy given Trump ally Robert F. Kennedy Jr.’s hostility to civil servants, he added. Trump has said he plans to give Kennedy, leader of the “Make America Healthy Again” movement, power over health care policy in his administration. “I’m biased, but I feel like the FDA is at peak performance right now and we’ll just see what happens as the new team comes in,” Califf said at a conference hosted by the nonprofit Friends of Cancer Research. Most FDA regulatory decisions are made by rank-and-file employees, but Califf noted that it is completely legal for the commissioner, president, or secretary of health and human services to overrule the entire agency. He said that although FDA decisions are meant to be rooted in science, they have always been subject to political pressure.