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How to navigate EU MAA Regulations and Registration For Chinese pharma and biotech companies looking to expand into the European Union’s market of over 450 million people, the first step is to understand the significant...

Want to know what’s missing in next-gen drug delivery? In this article for BioPharm International, ICON’s Head of Regulatory CMC, Venkat Sunkara, outlines current product development trends happening in the world of bio...

By integrating molecular design, advanced delivery technologies and robust manufacturing practices, pharmaceutical companies can translate cutting-edge biopharmaceuticals into safe, effective therapies that reach patient...

USP compounding may be fast — but is it costing you quality, compliance, and insight? In this insightful session, our experts discussed: - Why GMP manufacturing offers a strategic edge in early phase trials - Real-worl...

While cardiovascular outcome trials are critical to demonstrating clinical value, they can also be complex and costly. Among the most challenging aspects are the people involved, from patients to investigators and commit...

While cardiovascular outcome trials are critical to demonstrating clinical value, they can also be complex and costly. Among the most challenging aspects are the people involved, from patients to investigators and commit...

Continuing our series of articles discussing managing risk for medical devices, ICON’s regulatory expert Jeremy Tinkler turns his focus on the biological risk estimate and looks into the logical basis for the use of comp...

The key to estimating biological risk in medical devices is establishing a good comparison. However, identifying the right comparison can be challenging. In the latest blog in our managing risk for medical devices series...

Our Creative & Digital Services and Global Medical Communications teams have been honoured for the ISMPP Academy Poster with an Rx Club Award of Excellence in the Posters/Display category. Congratulations for delivering ...

Our Creative & Digital Services and Global Medical Communications teams have been honoured for the ISMPP Academy Poster with an Rx Club Award of Excellence in the Posters/Display category. Congratulations for delivering ...

2025 has seen both the EMA and the FDA publish new position papers and opinions on streamlining the trial process for biosimilars. On the surface, reducing reliance on comparative efficacy trials has the potential to sav...

There is great excitement following the announcements by the FDA and EMA around streamlining the biosimilar trial process. They promise to reduce the burden on developers and therefore increase the number of more afford...