• An interview with Franco Negron

    In this interview, we spoke with Franco Negron, CEO of Simtra, about how the company is advancing its position as a premier CDMO for sterile injectables while preparing for the next wave of complex biologics. read more
  • Horizon Lines: A Quarterly Review of NDAs – October- December 2025

    This quarterly review of New Drug Applications contains data for applications approved for the first time during the last quarter of 2025, which includes New Molecular Entities (NMEs) and new biologics. A total of 40 applications were approved by the FDA during these three months. read more
  • How Early Data Drives Better Cell Line Performance

    In the race to bring new biologics to market, development teams are constantly balancing speed, quality, and regulatory expectations. Yet one factor often determines long-term success more than any other: the strength of the data generated in the earliest phases of cell line development. read more
  • Limitations of Existing Life Science Software - and the Opportunity to Evolve

    ELNs, LIMS and SDMS systems aren’t going away anytime soon. They provide a foundation for doing reliable, collaborative, and impactful science. The key here is that by embracing and adopting new technologies, scientific organizations can protect their existing investments while unlocking new levels of efficiency, collaboration, and discovery - at their own pace and on their own terms. read more