Drugmakers Novartis and Bristol Myers halt or pause parts of their autoimmune disease cell-therapy programs after reports of patient deaths and severe, life-threatening side effects. Novartis pauses multiple trials of its rap-cel therapy following patient fatalities tied to a serious immune reaction. Bristol Myers then follows with precautionary pauses for its related autoimmune cell-therapy studies, citing safety concerns.
The companies are working to determine why the treatment triggered dangerous responses, and the trial freezes are being treated as a key test of patient safety and risk-management for the broader cell-therapy pipeline. Outlets report that the pauses create an urgent effort across teams and regulators to understand the underlying cause, including the nature of the immune reaction and which trial participants were affected.
While both sources agree on the core decision to stop trials and the seriousness of the outcomes, they differ in emphasis: one focuses on the immediate timeline and the number of studies affected by Novartis, while the other highlights the sequence of companies acting first and then following for precautionary reasons.