Top of the morning to you, and a fine one it is. Despite frigid temperatures and icy paths, we are getting off to a good start here on the Pharmalot campus, where the officials mascots are snoozing in their respective corners and we are firing up the coffee kettle for another cup of stimulation. Our choice today is maple cinnamon French toast. Sweets for the sweet, you know. Please feel free to join us. And now, here are your tidbits. Hope you have a productive and meaningful day, and, as always, please do keep in touch. We gladly welcome feedback, tips, and criticism. …
Pfizer took its next steps Tuesday in its attempted resurrection in the obesity market, STAT says. The company disclosed that an experimental weight loss drug, recently picked up through its contested acquisition of Metsera, hit its marks in a mid-stage study, demonstrating the potential to be a once-a-month treatment. Investors, however, will be parsing the data to assess how they compare to outcomes offered by other drugs in the increasingly competitive obesity market. Pfizer’s share price was down some 4% in pre-market trading as the company also reported 2025 earnings. At the data cut off, patients had been given the drug weekly for 12 weeks, and then monthly for another 16 weeks. Overall, the drug helped patients lose a placebo-adjusted 12.3% of their weight on average. Pfizer said all four dosing regimens tested outperformed placebo on weight reduction.
U.S. Food and Drug Administration officials are advising drug developers to study the long-term effects of using CAR-T to treat patients with autoimmune conditions, out of concern the therapies could cause cancer or fertility issues, STAT notes. The recommendations were outlined in an op-ed published in the Annals of Internal Medicine in which Vinay Prasad, who heads the FDA’s Center for Biologics Evaluation and Research, and two agency colleagues, recommended that long-term studies be conducted when using CAR-T to treat autoimmune diseases “as is standard for genetic therapies and CAR T-cells for oncological indications.” The paper does not specify how long autoimmune patients should be followed, but in cancer cases, the agency requires patients to be tracked for 15 years after the treatment is first administered. The op-ed also does not cite any specific cases in which any of the autoimmune patients who have received a CAR-T thus far developed cancer or secondary health issues. Continue to STAT+ to read the full story…