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  • The Next Test for AI in Pharmacovigilance Is Trust, Not Accuracy

    Monday, September 21, 2026
    An AI model can be right and still not be trusted. That’s what Bristol Myers Squibb (BMS) found six months into rolling out AI-powered adverse event processing: while F1 performance scores were tracking upward, the audit trail found reviewers still reopening cases the system had already cleared. read more
  • Horizon Lines: A Quarterly Review of NDAs – April to June 2026

    Monday, September 21, 2026
    This quarterly review on New Drug Applications contains data for applications approved for the first time during the second quarter of 2026, which includes New Molecular Entities (NMEs) and new biologics. read more
  • The Human Advantage in ADME Testing

    Friday, September 18, 2026
    Animal models do not accurately recapitulate several aspects of human physiology, and these differences lead to variations in drug behaviors across species. Each contributes useful evidence, but what is missing is the connected human biology needed to predict ADME behavior with confidence. read more
  • Upperton Receives MHRA License for Sterile Manufacturing Facility

    Thursday, September 17, 2026
    Upperton has received approval from the U.K. Medicines and Healthcare products Regulatory Agency for a variation to its Manufacturing and Importation Authorisation for Investigational Medicinal Products license covering a new sterile manufacturing facility in Nottingham. read more
  • From Data to Tissue

    Thursday, September 17, 2026
    The national-security regulatory landscape now layers a geopolitical framework onto the data flows, sample logistics, and vendor relationships that make modern clinical research possible. This architecture will not simplify. The DSP’s country-of-concern list may expand, the BIOSECURE Act’s ... read more
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