Author Archives: Patricia Inacio PhD

FDA Grants Breakthrough Therapy Designation to Gantenerumab

The U.S. Food and Drug Administration (FDA) has granted breakthrough therapy status to gantenerumab, a human antibody that’s expected to slow or even prevent cognitive decline and memory loss in Alzheimer’s disease. The FDA designation is intended to accelerate the development and review of candidate therapies with clinical…

FDA OKs Phase 1 Trial of Nasal Spray Immunotherapy Protollin

I-Mab will launch a Phase 1 clinical trial evaluating Protollin, its nasal spray immunotherapy candidate for Alzheimer’s disease. The biotech company’s announcement follows the recent approval of an investigational new drug (IND) application for Protollin by the U.S. Food and Drug Administration (FDA). “Advancing Protollin into clinic is…

Device to Spot Alzheimer’s Onset in Adults Recognized by FDA

Altoida’s artificial intelligence (AI)-powered device, intended to indicate the start of Alzheimer’s disease in adults with mild dementia but no evident disease symptoms, has been designated a breakthrough device by the U.S. Food and Drug Administration (FDA). The non-invasive device uses a software that measures and monitors neurocognitive function to…

Gosuranemab Fails TANGO Trial; Biogen Stops Development

Gosuranemab, an investigational antibody against the tau protein, failed to meet its primary and exploratory efficacy goals in the TANGO Phase 2 study, its developer, Biogen, has announced. Now, the TANGO trial has been terminated and Biogen will cease the clinical development of gosuranemab as a potential therapy for…