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News
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.
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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.
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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.
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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.
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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 ...
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