Because combination products do not fit neatly into a single category, their regulation can be difficult to navigate. However, there are several broad strategies that can help guide planning for drug-device combination p...
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Clinical success for CNS mAbs depends on more than mechanisms of action alone
The success of CNS monoclonal antibodies (mAbs) depends on more than innovative science. Robust clinical operations and safety governance are critical to protecting patients and advancing development. Discover the key operational considerations for neurologic mAbs in the article.
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Navigating the Risks and Rewards of Biomarker-Based Surrogates and Accelerated Approval
Examine how accelerated approvals can unlock earlier market access and why weak biomarker foundations, self-competitive confirmatory trials and payer misalignment remain critical risks.
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It’s complicated! When APAC global ambition meets regulatory reality
While not all sponsors plan to market treatments beyond the country of origin, many do. Those sponsors with global ambitions must decide which regulatory route offers the most strategic advantages and which market, particularly between the EU and US.
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June 2026 Medical/Commercial Pulse Check
With the first EU JCAs finalized and CMS extending deadlines for its ambitious Medicaid international-pricing model, ICON and other industry leaders share how they are navigating the friction between global harmonization and local execution including the practical evolution of global pricing floors, the maturing role of AI agents, and the new reality of European access.
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The Next Wave of Biosimilars: Why Hematology Is a High-Stakes Opportunity
A confluence of patent expiries and rising healthcare costs are accelerating both interest and investment in biosimilars across the world. In this article on Citeline we discuss how this relates to one of the major impacted areas, hematology.
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When your CRO’s AI platform upgrades, who pays for the change management?
This article examines the operations and cost considerations of ICON’s AI platform evolution, following it’s partnership with Microsoft to scale the Orbis platform across clinical trials.
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ICON names Microsoft tech partner as Q1 results grow analyst confidence
This article reports on ICON naming Microsoft as a technology partner to scale its Orbis AI platform, while highlighting growing analyst confidence driven by improving performance and demand.
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Biosimilar Success in an Evolving Landscape: Development Considerations for Staying Competitive
Regulatory pathways for biosimilars are changing, with reduced clinical requirements placing greater emphasis on analytical comparability and manufacturing excellence. Understanding how to respond to these shifts can make the difference between speed to market and costly delays. Explore the key considerations shaping today’s biosimilars landscape in ICON's latest article.
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ACT Brief: ICON-Microsoft AI Partnership, DCT Site Burden, and AI-Enabled Neuroimmune Discovery
This podcast discusses ICON’s selection of Microsoft as a preferred technology partner to scale its agentic AI platform across the clinical trial lifecycle.
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ICON selects Microsoft to power AI-enabled clinical development
This article reports on ICON’s selection of Microsoft as a preferred technology Partner, bringing Microsoft 365 Copilot, Azure, and AI infrastructure to scale its Orbis Platform and enable AI-driven clinical development.
