A Food and Drug Administration adcomm announced it will review Eli Lilly’s Alzheimer’s drug candidate donanemab on June 10. The panel of Alzheimer’s experts will question the pharma giant’s data and set up an approval decision following a surprise delay by the FDA in early March. (Reuters)
TikTok sued the federal government in an effort to stop enforcement of a bill that seeks to force the app’s Chinese owner ByteDance to sell the app or have it banned. Legal proceedings will pause that timeline, meaning it could be years before a TikTok ban goes into effect. (NBC News)
Zenas BioPharma closed a $200 million Series C funding round to support its research of autoimmune treatments. Zenas is testing obexelimab in Phase 3 for IgG4-related disease — which can cause tumor-like growths on some organs — and in Phase 2 for multiple sclerosis, systemic lupus erythematosus and warm autoimmune hemolytic anemia. (Endpoints News)
A young boy died in a trial for Pfizer’s experimental gene therapy for Duchenne muscular dystrophy, the company told patient advocates. The boy was enrolled in Daylight, a trial studying the treatment in boys aged 2 or 3, and had received the therapy early last year. (Seeking Alpha)
A study published this week suggested that a gene variant plays an even more important role than scientists had realized and causes a distinct form of Alzheimer’s. Nearly all of the APOE4 homozygotes showed biological signs of Alzheimer’s in the brain, and they typically developed dementia and other symptoms, and died sooner than people with Alzheimer’s who lack APOE4. (STAT News)
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