highlights

Europe and Global Health: between bold promises and the risk of overreach

Report COM (2025) 392 outlines several advances in the implementation of the EU Global Health Strategy: financial contributions to Gavi, the Global Fund, and the Pandemic Fund; strengthened European preparedness capacities; and enhanced policy synergies through “Health in All Policies” and the Team Europe approach. However, concerns persist regarding sustainable financing, effective coordination among Member States, and the concrete assessment of impact.

AI: Between a Free-for-All and Hard Boundaries

Starting August 2, 2025, the European AI Act enforces rules for general-purpose AI models, requiring transparency and safety for high-risk applications such as those in the pharmaceutical sector. America’s AI Action Plan prioritizes innovation. Companies will need to strike a balance between compliance and agility.

Business

Genitourinary Tumor Study ongoing with Active Screening and Enrollment

Genenta announces Long-Term follow-up observations in brain tumor (GBM) study with emerging survival signals

CE marking for substance-based medical devices and drug-device combination products

BSI, full-scope Notified Body for all three types of devices pursuant to MDR and IVDR, is able to offer verification services for compliance with European directives about the production of medical devices

MAGAZINE

MakingPharmaIndustry | March 2025 | Issue 1

In the March multimedia magazine, we explore the impact of artificial intelligence and cybersecurity regulations in the pharmaceutical industry. As artificial intelligence reshapes drug development,...

MakingPharmaIndustry | The Magazine of the Pharma World | Issue 1_2025

This special issue explores the impact of automation and AI on pharmaceutical production—across GxP, sustainability, and digitalization.
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