<span>Three ways to help prevent dementia and Alzheimer’s disease</span>
June 13, 2024

Three ways to help prevent dementia and Alzheimer’s disease

June is here—and in addition to officially kicking off summer, it’s also Alzheimer’s and Brain Awareness Month. While June is used to recognize and support those experiencing cognitive decline, it can also be a month for both young and old to take proactive steps to achieve and maintain optimal brain health.
<span>Cell and Gene Therapy Answers: What to know about companion diagnostics development</span>
June 4, 2024

Cell and Gene Therapy Answers: What to know about companion diagnostics development

A companion diagnostic (CDx) is an in vitro diagnostic providing essential information for the safe and effective use of a corresponding therapeutic product. By identifying patients most likely to benefit from or who are at risk of adverse events from a therapy, CDx can help guide decisions for targeted treatment strategies—which is why many regulatory bodies now recommend incorporating CDx within cell and gene therapy (CGT) programs. However, for many developers, questions remain about when CDx are truly needed, how to choose the right CDx partner and the kind of testing required for CDx assays. To gain clarity on CDx strategy and best practices, we spoke with Devin Craven, associate director of regulatory affairs for Labcorp, and Laura Huning, a scientist for Labcorp’s diagnostic development services.
<span>ECHA guidelines</span>
June 4, 2024

ECHA guidelines

ECHA sets deadlines to provide data after dossier and substance decisions are issued

Following a dossier or substance evaluation from the European Chemicals Agency (ECHA), standard deadlines to provide data (normally, new study data) will be provided in a draft decision letter.