Earlier this month, colleagues from ICON Mexico came together for our fifth consecutive Blood Donation Campaign. Around 90 colleagues registered to take part, with 37 successfully donating blood following assessment by ...

The EU’s PPWR is not a standalone regulatory change. It is a strategic transformation that touches the entire product lifecycle. In this article ICON’s Global Labelling & Ad Promotion team outlines practical recommendat...

Heart failure affects millions of people worldwide and can significantly impact quality of life. Research into new treatment approaches remains critical to improving outcomes and expanding options for patients living wit...

Biomarker-based surrogate endpoints can accelerate development timelines – but only when the evidence, pathway and expectations are aligned. In the latest issue of Drug & Device World ICON’s Elizabeth Madichie and Jack ...

The success of CNS monoclonal antibodies (mAbs) depends on more than innovative mechanisms of action. Rigorous clinical operations and robust safety governance are critical to protecting patients and advancing developmen...

"Plan early" remains key in the new EU HTA landscape. Companies should proactively map evidence needs across key countries, pursue joint scientific advice where possible, and allocate additional time and budget for anal...

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...

For APAC biotechs with global ambitions, choosing the right regulatory pathway can be a critical strategic decision. In PharmaTimes Magazine, ICON’s Senior Director of Regulatory Strategy, Graham Bell, explores the comp...

Agentic AI is reshaping how work is executed in biopharma. In this Bio-IT World article, ICON’s SPV of Enterprise AI, Tony Clarke, explores the shift from task-based automation to coordinated, autonomous workflows – whe...

Sites are often asked to adapt to sponsor and CRO processes that sit outside their day-to-day workflows. What if we took a different approach? Join Brian Mallon (ICON), Scott Uebele (Advarra), Denise Snyder (Duke Univer...

The first EU Joint Clinical Assessments (JCAs) may reduce some duplication in clinical assessments, but they are also creating new challenges for evidence planning. Mia Malmenäs of ICON notes that manufacturers are navi...

Companies that have not historically developed biosimilars are recognising the opportunity represented by recent regulatory changes. Discover how the biosimilars market is being impacted and how developers can help the...