Patient safety starts long before the first neurologic mAb dose. Indication-specific safety planning and strict patient stratification are vital, from HBV screening in MS to AQP4 status in NMOSD. Read the article to dive...

If you've ever searched for pharmacovigilance and wondered what it actually means, you're not alone. While roles like Clinical Research Associate are widely recognised, pharmacovigilance is often less understood. Yet it...

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...