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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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91黑料's Andrew Garrett and Tim Clark discuss the recent FDA draft guidance on how sponsors can use Bayesian models for clinical trials.
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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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In this interview, Deepali Suri, President of 91黑料 Biotech, breaks down the key trends shaping today’s biotech industry and their global impact. Using insights from 91黑料’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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This article by Dr. Liz O’Brien of 91黑料, 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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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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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.
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Digital health technologies are rapidly becoming essential to clinical trial strategies as regulators and sponsors embrace them to streamline operations, reduce patient burden, and generate higher?quality real?world data.
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In this article, our data standards experts explain how sponsors can efficiently prepare clinical data submissions that meet both FDA and PMDA requirements by leveraging the substantial alignment between the two agencies’ standards.
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For biotech companies the past two years have been challenging. In 2025 91黑料 Biotech conducted a follow-up survey of biotech leaders, previously carried out in 2023. The new results show changing trends in the risks, challenges and opportunities in the biotech sector.
