STAT+: Pharmalittle: FDA probes CAR-T therapy for links to lymphoma; White House official attacks Bristol over Medicare price talks

The FDA is investigating whether CAR-T therapy, which uses genetically modified white blood cells to attack tumors, can in rare cases cause lymphoma.

Nov 29, 2023 - 18:00
STAT+: Pharmalittle: FDA probes CAR-T therapy for links to lymphoma; White House official attacks Bristol over Medicare price talks

Good morning, everyone, and how are you today? We are doing just fine, thank you. Given that this is already the middle of the week and we have survived this far, no reason not to continue, yes? Just consider the alternatives. In fact, this modest accomplishment calls for celebration. So please join us in quaffing a ritual cup of needed stimulation. Our choice today is gingerbread. Or grab a bottle of water, if you prefer. Meanwhile, here are a few items of interest to help you along. We hope you have a meaningful day and, of course, keep in touch. We enjoy hearing your tips and tidbits. Telegrams and postcards are still accepted, by the way. …

The U.S. Food and Drug Administration is investigating whether CAR-T therapy, which uses genetically modified white blood cells to attack tumors, can in rare cases cause lymphoma, a blood cancer, STAT says. The agency noted that it is investigating reports of T cell lymphoma, including cancer cells carrying the engineered T cells, in patients who received CAR-T therapy. Experts in the field, which has produced multiple approved products to treat blood cancer, expressed surprise and puzzlement at the announcement, saying that they had not previously seen data about the risk.

Senior Biden administration officials met with RSV vaccine makers to underscore the need for manufacturers to urgently meet demand as winter approaches, Reuters writes. At a White House meeting, the manufacturers agreed to plan now to meet next year’s demand for the vaccines targeting respiratory syncytial virus, which generally causes mild, cold-like symptoms but can develop into severe illness in infants and older adults. Separately, the U.S. Centers for Disease Control and Prevention said it had expedited the release of more than 77,000 additional doses of Sanofi and AstraZeneca’s RSV drug Beyfortus, which was approved earlier this year to prevent the disease in infants and toddlers.

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