Blogs

For decades, clinical development leaders in US and Europe have viewed China primarily through a logistical lens: a large patient pool capable of accelerating trial enrolment. However, the industry dynamics…

FDA’s 2026 draft guidance quietly rewrites the rules for how Bayesian methods can drive—not just decorate—primary efficacy decisions in drug and biologic trials, but sponsors still face major friction around…

The FDA released final guidance on real-world data in July 2024. The EMA expanded DARWIN EU to 30 partners covering 180 million patients across 16 European Countries (EMA, 2025). Japan's PMDA now…

Seventy-seven percent of drugs for rare diseases with pivotal efficacy data have orphan designations, and most are approved with Phase III randomized controlled trials (Domike et al, 2024). This creates…

The estimands framework is not optional sophistication. It's becoming mandatory intellectual honesty about what research questions a trial will actually address. Organizations that treat estimands as a regulatory checkbox rather…

For the first time, FDA has declared that one pivotal trial plus confirmatory evidence will be its default pathway for drug approval—effectively ending the informal “two-trial” expectation that has shaped…

The field of inflammation and immunology has historically revolved around monotherapy—single cytokine blockade or single pathway inhibition. IL-23 inhibitors, TNF-alpha antagonists, and IL-6 receptor blockers: each represent a single point…