Author Archives: Patricia Inacio PhD

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…

Longeveron’s Stem Cell Therapy Shows Potential in Phase 1 Trial

Longeveron’s Lomecel-B, an investigational bone marrow-derived medicinal signaling cell (MSC), showed an ability to slow cognitive decline and the loss of daily life abilities in patients with mild Alzheimer’s disease relative to those given a placebo in a Phase 1 clinical trial, the company announced. Treatment with Lomecel-B was deemed safe,…

Non-invasive Neurostimulation Device Wins FDA’s Breakthrough Status

Cognito Therapeutic’s neurostimulation device — a next-generation digital therapeutic designed to treat memory and cognition symptoms in Alzheimer’s disease — has been granted a breakthrough device designation by the U.S. Food and Drug Administration (FDA). The device, part of a new class of disease-modifying digital therapies, uses proprietary,…