Drugs

Roche Reports Positive Data on Alzheimer’s Drug

Roche is reporting new data on its Alzheimer’s therapy trontinemab and its plans to begin two Phase 3 clinical trials by the end of the year. Trontinemab, delivered via Roche’s proprietary Brainshuttle technology, continues to show promising results in an ongoing Phase 1b/2a study, according to the company. After 28 weeks of treatment, 91% of participants in the 3.6 mg/kg cohort demonstrated a significant reduction in amyloid plaques, becoming PET scan-negative for amyloid pathology — a hallmark of Alzheimer’s disease, it says. Deep plaque clearance was seen in 72% of patients. The rate of ARIA-E, a potential side effect linked to anti-amyloid therapies, remained below 5%, with all cases mild and mostly symptom-free, it adds.

Roche plans to launch two global Phase 3 trials, TRONTIER 1 and 2, by the end of 2025 to evaluate trontinemab in people with early symptomatic Alzheimer’s. Both studies will use changes in cognition and function, assessed via the Clinical Dementia Rating – Sum of Boxes (CDR-SB), as the primary endpoint after 18 months of treatment. The company also announced plans for a third Phase 3 trial targeting individuals in the preclinical stage of Alzheimer’s who are at high risk of cognitive decline.

Additionally, Roche announced encouraging real-world data on its Elecsys pTau217 and pTau181 assays, which are designed to detect Alzheimer’s disease using a blood sample. These blood-based biomarkers were shown to be comparable to PET scans and cerebrospinal fluid tests in detecting amyloid pathology, the company says.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome