Latest Articles

  • 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

  • Executive Q&A - A Strategic Acquisition: Insights and Ideas

    An interview with Brian Morrissey, General Manager of Gaelic Laboratories, which has acquired Athlone Laboratories in a strategic deal that typifies the current pharma M&A landscape and puts all of Ireland’s Beta-Lactam manufacturing capacity under one ownership umbrella. read more

  • Shore to Please

    As this year is coming rapidly to a close, I thought it might be interesting to review the ten biggest announced projects since January: read more