Operations

An examination of proactive preparedness and readiness review for future enrollment in the agency’s QMM program—now in the pilot stage as an effort to incentivize pharma manufacturers to achieve a more mature state of quality culture.

Despite steady innovation and solid new drug approvals, the first half of 2025 was marked by a break from historical norms in financing, stock performance, and M&A for the pharma and biotech sectors.

With reports that FDA’s AI Elsa is “confidently hallucinating” studies that don’t exist, the use of AI to streamline drug review and speed up approval is not here yet.

A well-defined scientific and strategic approach is critical for buyers in this dealmaking setting.

Five steps for organizations in bringing enterprise-level strategies to life.

The Zensights Federated Healthcare Advisory Panel explores how shifting global dynamics are reshaping access and strategic planning across the healthcare system.

Investment is expected to bring approximately 1,000 new jobs at Novartis and 4,000 additional roles across the United States.

Eli Lilly CEO David Ricks to the BBC: “It feels like it'll be hard to come back from here."

The facility, which is set to open amid Biogen’s 50th anniversary, will integrate research and development, technical operations, and commercial teams into one location.

The investment, which is a 25% increase from previous years, will support three new advanced manufacturing facilities, expansions at existing sites, and R&D efforts.