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Single Pivotal Trials Demand Stronger Data and Risk Strategies
Single-trial approvals are raising the bar on trial design and execution. The new paradigm is pushing sponsors to plan earlier, step up their data and risk‑based quality management and use modeling and AI to generate one compelling, regulator‑ready evidence package.
March 10, 2026
·
3 min read
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Jennifer C. Smith-Parker
Manufacturing
Nonprofit Aims to Modernize Manufacturing by Clearing Capital Hurdle
Industry groups have identified upfront costs as a barrier to streamlining U.S. drugmaking. The nonprofit API Innovation Center has a proposed answer for how to tilt finances in favor of investments in continuous manufacturing.
March 10, 2026
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4 min read
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Nick Paul Taylor
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March 9, 2026
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March 9, 2026
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March 9, 2026
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ProstACT Global Phase 3 Study (Part 1) Achieves Primary Objectives
March 9, 2026
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Precision BioSciences to Report Fourth Quarter and Fiscal Year 2025 Results on March 12, 2026
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Transcat Appoints Jaime Irick as President and Chief Executive Officer
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Prothena Announces Achievement of $50 Million Clinical Milestone Payment from Novo Nordisk Related to Ongoing Phase 3 Clinical Trial for Coramitug (Formerly PRX004) in ATTR Amyloidosis with Cardiomyopathy
March 9, 2026
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Vertex Announces Positive Week 36 Interim Analysis Results for Primary and All Secondary Endpoints in the RAINIER Phase 3 Trial of Povetacicept in Adults With IgA Nephropathy
March 9, 2026
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