Exclusive | Drugmakers Halt Autoimmune Trials After Deaths, Life-Threatening Side Effects
wsj.com/health/pharma/drugmakers-halt-autoimmune-trials-after-deaths-life-threatening-side-effects-14e786fd
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Serious Safety Events Halt Autoimmune CAR-T TrialsNovartis reported three study deaths; Bristol Myers cited ICANS, a form of brain inflammation, during its research pause.
- In early June, Bristol Myers told regulators, researchers and patient groups about a pause over life-threatening side effects; public disclosure came three months later.
- Novartis confirmed a similar pause in August after an analyst found it, then reported three study-participant deaths one week later.
- Novartis has enrolled more than 500 patients across eight autoimmune trials of rap-cel; Bristol Myers halted other studies beyond lupus.
- Novartis’s cases involved a rare immune-system overreaction; Bristol Myers cited ICANS, a form of brain inflammation.
Every piece of information is critical.— Dr. Anca Askanase, rheumatology chief at the Hospital for Special Surgery in New York City, commenting on the need for full disclosure and detail surrounding the paused autoimmune-trial data.
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