Antibody-drug conjugates (ADCs) continue to reshape global oncology, yet navigating the evolving regulatory landscape remains a significant challenge. In this new BioSpectrum Asia feature, ICON’s regulatory expert, Eili...
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Beyond viral suppression: Next-generation HIV therapeutics target reservoirs, broadly neutralising antibodies, and gene editing
Long-acting injectables have transformed HIV management, but viral suppression alone is not enough. Researchers are advancing mRNA vaccines, broadly neutralizing antibodies, latency-reversing agents, pediatric immune strategies, and gene editing to eliminate reservoirs and achieve remission. Here’s how next-generation HIV therapeutics aim to move beyond lifelong ART.
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China biotech continues its growth trajectory
Yao Zhong, vice president general manager for ICON China Mainland and Hong Kong, discusses latest survey results on the Chinese biotech market.
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Mission (im)possible? Efficient Global Antibody Drug Conjugate Product Approvals
Antibody-drug conjugates (ADCs) continue to reshape global oncology, yet navigating the evolving regulatory landscape remains a significant challenge. In this latest ICON Regulatory Affairs article we outline the strategic considerations essential for efficient global development. See page 42.
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From uncertainty to strategy: Guiding vaccine decisions in rare autoimmune conditions
Rare autoimmune diseases can increase patients’ vulnerability to infection and often require tailored considerations for vaccination. Read the article to learn what makes these cases distinct and what to factor in when designing a vaccine schedule.
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The Bayesian challenge: complexity that pays off
ICON's Andrew Garrett and Tim Clark discuss the recent FDA draft guidance on how sponsors can use Bayesian models for clinical trials.
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Flexible formulation strategies boost early phase clinical success
Early phase clinical success relies on simple, flexible formulations that can adapt to wide dose ranges, support matching placebos, and deliver reliable stability. This article explores how formulation strategies enable dose escalation, maintain blinding integrity, and streamline development in first‑in‑human trials. It also highlights practical considerations for selecting dosage forms and designing stability programs that balance speed, cost, and clinical needs.
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2025 in Review: Global biotech and funding trends
In this interview, Deepali Suri, President of ICON Biotech, breaks down the key trends shaping today’s biotech industry and their global impact. Using insights from ICON’s global and China biotech surveys, capturing input from more than 260 biotech leaders worldwide, Suri highlights emerging therapeutic innovations, the growing influence of AI in R&D, and how geopolitical tensions are redefining international drug development strategies.
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More than a statistic: What EU Joint Clinical Assessment changes for oncology patients
This article by Dr. Liz O’Brien of ICON, outlines how the EU Joint Clinical Assessment is reshaping global oncology drug development by driving earlier evidence generation, strengthening patient‑centered trial design and enabling more equitable access to innovative treatments across Europe. It underscores the growing emphasis on patient insights, PROs and cross‑functional evidence planning one year after JCA implementation.
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The “R” in CRO: How and why CROs should harness open-source R software
In this Journal of mHealth article, Ashish Koul explains how open-source R software empowers CROs to modernise statistical workflows, cut costs and deliver more transparent, scalable analyses.
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From biopsy bottlenecks to biomarker breakthroughs - how non-invasive tools are reshaping MASH trials
This article examines how non-invasive testing could transform the management of metabolic liver disease and help shape the future of MASH clinical development. It also outlines the rapidly evolving NIT landscape, emerging regulatory perspectives, and key opportunities to optimise MASH trial design and execution.
