Pharma Pulse 4/24/25: Understanding True Meaning of Risk in Clinical Trial Operations, European Pharma Companies Push for Higher Drug Prices Amid US Tariff Threats

Understanding the True Meaning of Risk in Clinical Trial Operations

In a recent interview with Applied Clinical Trials, Rob Jones of Pharmalex emphasized the need for TMF leaders to adopt a truly risk-based, quality-by-design mindset. This includes embracing innovations such as AI, focusing on critical records, and adapting to rapidly evolving regulations such as ICH E6(R3) and E8(R1), while recognizing that “fit-for-purpose” may now be an acceptable standard in balancing complexity, cost, and compliance.

European pharma companies push for higher drug prices in EU amid US tariff threats

European pharma CEOs, including those from Novartis and Sanofi, are urging the EU to adopt higher, US-aligned net pricing for new medicines to boost innovation and investment, warning that current price controls make the region less competitive amid rising US incentives and tariff threats.

Making Real-World Evidence Work for Medicare: What CMS’ Draft Guidance Gets Right and What Needs Work

A Pharmaceutical Executive feature by Patrick Arena, PhD, MPH, highlights CMS’ recent draft guidance on, noting it advances Medicare coverage decisions using real-world data, though refinements are needed to improve clarity, usability, and alignment across agencies.

FDA asks Novavax for post-marketing data pledge amid stalled COVID shot review

Despite missing its April 1 deadline to decide on full approval for Novavax’s protein-based COVID-19 vaccine, the FDA has requested additional post-marketing data, raising concerns over regulatory delays potentially linked to mass HHS layoffs and political interference, as broader US policy shifts threaten to limit vaccine recommendations and impact future sales across the industry.

Eli Lilly sues four telehealth sites selling compounded Zepbound, Mounjaro

Eli Lilly is suing four telehealth companies—Mochi Health, Fella Health, Willow Health, and Henry Meds—for allegedly selling unapproved, compounded versions of its weight loss and diabetes drugs Zepbound and Mounjaro. The suit alleges these companies mislead consumers, violated FDA rules, and unlawfully influenced prescribing practices as the company intensifies efforts to curb the growing market for copycat GLP-1 treatments.