The company is downsizing its gene therapy operations following reduced demand from a major client, even as industry reliance on CDMOs and CMOs for capacity and expertise continues to grow.
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.