Remove tag pathology
article thumbnail

Roche’s Early Alzheimer’s Blood Test Gets FDA Breakthrough Device Designation

XTalks

The Elecsys pTau217 assay is designed to detect amyloid pathology, a hallmark of Alzheimer’s disease, by measuring phosphorylated tau protein in human plasma. Previously, Roche secured an FDA breakthrough tag for another one of its Alzheimer’s blood tests that detects levels of pTau-181 and ApoE4 (apolipoprotein e4).

article thumbnail

Potential disease-modifying therapy for Parkinson’s disease

Drug Discovery World

Importance of healthy mitochondrial function Dysfunctional mitochondria are usually tagged for removal via mitophagy with a protein ‘flag’ called ubiquitin. These new findings suggest that maintaining healthy mitochondrial function by blocking USP30 may slow or even stop the progression of pathology which drives PD.

In-Vivo 52
Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

First gene therapy trial for Hunter syndrome opens in Manchester, UK

Drug Discovery World

The newly inserted IDS gene produces an IDS enzyme that contains a proprietary ApoEII-tagged sequence, which can bind to ApoE-dependent receptors on the blood brain barrier, and move enzyme into the brain more efficiently, thus potentially normalising brain pathology.

article thumbnail

Grand Rounds Ethics and Regulatory Series October 14, 2022: Responding (or Not) to Signals of Potential Clinical Significance in Pragmatic Clinical Trials (Joseph Ali, JD; Tanya Matthews, PhD; Leslie J. Crofford, MD)

Rethinking Clinical Trials

Professor of Medicine and Pathology, Microbiology & Immunology. Johns Hopkins Berman Institute of Bioethics. Tanya Matthews, PhD. HRPP Director. Kaiser Permanente Washington. Crofford, MD. Wilson Family Chair in Medicine. Chief, Division of Rheumatology. Vanderbilt University Medical Center. Ethics, IRB, FM-TIPS. Key Points.

article thumbnail

Roche’s anti-amyloid beta antibody gantenerumab granted FDA Breakthrough Therapy Designation in Alzheimer’s disease

The Pharma Data

This designation is predicated on data showing that gantenerumab significantly reduced brain amyloid pillar, a pathological hallmark of Notice, in the ongoing SCarlet RoAD and Marguerite RoAD open- tag extension trials, as well as other studies.

article thumbnail

Biogen’s Aducanumab Becomes First Drug Approved for Alzheimer’s in Nearly 20 Years Despite Controversy

XTalks

Aducanumab Controversy and Price Tag. Of the three studies, two were Phase III trials — the EMERGE and ENGAGE studies — which involved patients with early stages of Alzheimer’s disease (mild cognitive impairment and mild dementia) with confirmed presence of amyloid pathology.

Drugs 98
article thumbnail

AI is critical to solving new complexities in drug discovery

Drug Discovery World

At the same time, we are developing a better understanding of disease pathology, leading to a more complicated picture of how diseases manifest. The second scenario is that a better understanding of complex disease pathology will unlock new insights that lead to new, more effective and safer therapies. This creates two scenarios.

Drugs 52