A 2026–2027 joint work program operationalizes EMA–EISMEA cooperation to move European Innovation Council-funded projects ...

A distributed “hub-and-spoke” operation could register as one establishment, reducing administrative friction while improving ...

USP standards enhance reliability by reducing process variability, improving technology transfer, and supporting regulatory alignment, particularly relevant for generics and multi-site manufacturing ...

Fragmented plant data across silos drives late investigations and corrective action; connected architectures unify PAT, sensors, batch, quality, and maintenance signals to enable earlier risk ...

A single-registration pathway would allow distributed networks to add, remove, or relocate units with less administrative complexity while maintaining centralized quality oversight and improved FDA ...

Phased assessment allows CHMP to evaluate CMC, nonclinical, and clinical data as they mature, rather than waiting for a complete centralized marketing authorization application. High-priority ...

Greater accountability and resilience across drug development and manufacturing are key goals for regulators and industry. This week, regulators, dealmakers, and manufacturers converged on the same ...

Dual BAFF/APRIL blockade targets upstream B-cell maturation/plasma cell survival; lowers Gd-IgA1 and autoantibodies, reducing immune complex deposition and glomerular inflammation. ORIGIN 3 interim ...

Optimization-by-design and early process development decisions determine downstream material, energy, solvent, and water intensity, making sustainability primarily a chemistry and engineering choice ...

Operational margins increasingly track efficiency, making manual steps and disconnected systems direct drivers of cost, delays, and variable quality at higher sample volumes. Automated, standardized ...