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 ...

PharmTech spoke with Jamie Evans, manager of analytical method development and validation, and Joe Cobb, CPIP, manager of formulations, both with Lonza Capsugel, about best practices for ...

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 ...

Tim Stroud is Solutions Consultant Team Leader at Cenevo. He is an experienced life sciences professional with more than 20 years in the pharmaceutical drug discovery industry. Prior to joining Cenevo ...

Teva gains exclusive commercialization rights for IV and SC ocrelizumab biosimilar formulations across the US, Europe, Brazil, Canada, Australia, New Zealand, Israel, and Turkey, pending approvals.

Patient nonadherence rates of 30%–50% are linked to dosing complexity and poor acceptability, motivating patient-centered formulation strategies, especially for pediatrics and older adults. A ...

Angela Strzelecki, PhD, is senior vice president of the Roquette Group and CEO of Roquette’s Health & Pharma Solutions Business Unit ...

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

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 ...

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 ...