Regulatory & Industry

The Synthetic Molecule Process Innovation Phorum brings together major pharma companies, regulators, and CDMOs to build consensus on pressing challenges in small molecule manufacturing. 

The MHRA-led sandbox will generate real-world evidence on AI tools that could improve medicines safety, reduce late-stage failures, and accelerate drug development.

The FDA announced interest in advancing drug repurposing programs across a wide variety of conditions, though challenges remain.

This year’s New Product Award winners reflect growing demand for tools that improve throughput, reproducibility, and hands-free operation in the lab.

A policy update removes a longstanding barrier for medical device sponsors and signals a broader shift that could eventually reshape how drug and biologic developers approach evidence generation.

Disruptions to key Middle East logistics corridors are rippling through pharmaceutical supply chains, raising costs and testing resilience, but not yet triggering shortages.

Industry leaders at the Advanced Therapies conference outline how early collaboration, funding, and culture shape whether breakthroughs reach patients.

Ireland’s model for advanced therapy manufacturing integrates academic research, workforce development, and regulatory bodies to streamline the production of complex biologics.

Automation, digital manufacturing, and regulatory reform are reshaping how the UK competes in cell and gene therapy as the field moves toward routine delivery.

Tariff-free US access and pricing reforms give the UK a potential edge in an uncertain global market.

While faster reviews could bring life-saving treatments to patients sooner, compressed timelines could also limit regulatory scrutiny and strain FDA resources.

Eli Lilly’s oral orforglipron and Novo Nordisk’s higher-dose WeGovy could be approved on an extremely accelerated timeline.