Real-World Evidence

FDA’s proposed easing of biosimilar pathways is a mixed blessing for CROs even as it, along with tariff threats and funding scarcity, has led to paused clinical studies. Parexel’s India head talks about keeping up with the regulation and other AI-led changes in this interview.

The verdict from the front lines of drug development is unmistakable: RWD and AI won’t transform trials through hype alone – they deliver only when welded to airtight data practices, transparent models and accountable operations.

Real-world evidence (RWE) studies in India face challenges like lack of data reliability and uniformity and absence of clear guidelines but firms like Bharat Serums have scored a regulatory win. Pink Sheet examines the RWE landscape and the BSV case study for lessons in beating the odds

Bharat Serums showed it’s possible to score a regulatory win with real-world evidence (RWE) studies in India when it ran one leading to a label expansion for its mAb trinbelimab. As cell and gene therapies and rare disease drugs gain currency, sponsors could look at takeaways from the RhYTHM study.

A new AI-based platform is designed to condense months of clinical data analysis into minutes by translating plain language data queries into epidemiologically valid research requests.

The French company will start shipping its blockbuster shortly to meet expected strong demand in the 2025–26 RSV season.

In the final part of an interview with Scrip, Menarini’s Asia-Pacific CEO talks about the group’s digital capabilities, including their impact on a shortage issue in Australia, and leveraging RWE to inform healthcare practices across the region. The Italian company is also revving up its business development and alliance engine.

Draft guidance from the European Medicines Agency explores how data quality can impact the use of real-world data to generate real-world evidence for regulatory assessments.

The US FDA’s Office of Women’s Health provides a research roadmap to address health concerns specific to women. The FDA recently updated the roadmap, outlining areas in which further research is needed.

The Cardiovascular and Renal Drugs Advisory Committee voted 10-6 that efficacy had been shown for the ultra-rare disease, but even panelists in the majority questioned whether the product satisfied the threshold requirement for an adequate and well-controlled study.

The US FDA’s Office of Women’s Health provides a research roadmap to address health concerns specific to women. The FDA recently updated the roadmap, outlining areas in which further research is needed.

While they could speed enrollment and lead to more representative samples, based on what FDA says local health care providers would be allowed to do as part of trial conduct, there may only be limited opportunities to integrate clinical studies into routine clinical practice.