Skip to main content
SciBX
Feature Story

The FDA's push for better biomarkers

By Lauren Martz, Staff Writer

The FDA's push for better biomarkers

Despite the huge output of preclinical papers on new biomarkers, few result in validated agents that contribute to clinical trials. The FDA turned to stakeholders from industry and academia last week to discuss the challenges in the space and hear proposals for how to address them. Meeting attendees agreed that clarity and standardization of the regulatory process involving biomarkers is critical for advancing the use of biomarkers.

Full Article

Today's Biotech & Pharma News

Battling Ebola

  • COVER STORY

    Neutralizing HIV rebound

    Rockefeller University researchers have shown that broadly neutralizing antibodies against HIV envelope proteins can knock the virus out of its latent reservoirs, thus opening an inroad to fully eliminating HIV from infected individuals.

  • TRANSLATIONAL NOTES

    The FDA's push for better biomarkers

    The FDA is calling on stakeholders to help define a path for validating and approving biomarkers to enable their use in drug development.

  • Translational tidbits

    The FDA reviews the status of RNA sequencing; Serono builds on its lupus partnerships; Genomics England receives over £300 million ($500 million) in new investments; a roundup of recent public-private partnerships.

  • TOOLS

    Bad blood

    Whereas pharmacological approaches to treat sepsis have languished in the clinic, a microfluidic device developed by a Massachusetts team cleanses pathogens and endotoxins from blood and increases survival in rat models of sepsis.

  • THERAPEUTICS

    This Week in Therapeutics

    Countering MEK and BRAF inhibitor resistance in cancer by disrupting eIF4F; treating DMD with CRISPR-mediated genomic editing; inhibiting CRFR1 signaling to prevent hypoxia-induced cerebral edema; and more...

  • TECHNIQUES

    This Week in Techniques

    A marmoset model of MERS-CoV infection; a fully functional thymus generated from reprogrammed fibroblasts; noninvasive methods for diagnosing Creutzfeldt-Jakob disease; and more...

Subscribe Now
Free Trial