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The FDA MyStudies app

Experts has developed a mobile application and secure patient data storage platform – FDA MyStudies – to address privacy, engagement […]

FDA staff back controversial Alzheimer’s drug

In a lengthy statement released on Wednesday, FDA staff appeared to endorse Biogen’s treatment for Alzheimer’s disease. If approved, this […]

FDA benefit-risk frameworks for drug approval

In a recent study published in Therapeutic Innovation and Regulatory Science, researchers conducted a systematic review of the decision factors […]

FDA releases list of evidence-based pharmacogenetic variants

Pharmacogenetics (PGx) is the study of how an individual’s genetic makeup affects their drug response and metabolism. An understanding of PGx could help clinicians make prescribing decisions and has the potential to be implemented in routine care worldwide. PGx has understandably been gaining traction and support, with pharmacogenomic elements being implemented into many international Genomic studies.

New Alzheimer’s Drug Data Issues

Earlier this week the U.S. Food and Drug Administration approved the first new treatment for Alzheimer’s disease in almost 20 […]

Ivermectin as a potential drug for treatment of COVID-19.

Numerous datasets from historic clinical trials are being reviewed in the hope that existing drugs, that have already been cleared […]

Surrogate Endpoint Evaluation Methodology

Robust identification of clinical trial surrogate end points can help to accelerate the development of pharmacotherapies for diseases that are […]

Discovery of Candidate Antibody-Drug Conjugate Targets

A recent study used the Human Protein Atlas as a unique big data resource to identify and prioritise candidate antibody-drug […]

Facilitating Remote Clinical Trials – A Review

Following the COVID-19 outbreak, which caused unprecedented disruption to the running of clinical trials, there has been an increasing interest […]

Ensemble Learning-Based Method for Inferring Drug-Target Interactions

A recent study presented a novel computational method for inferring drug-target interactions, which exploits the primary protein sequence and molecular […]