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 ...
USP standards enhance reliability by reducing process variability, improving technology transfer, and supporting regulatory alignment, particularly relevant for generics and multi-site manufacturing ...
Lonza will add commercial-scale manufacturing for highly complex HPAPIs and ADC payload linkers at Visp, expanding capacity ...
This episode of Ask the Expert takes a look at recent regulatory actions impacting biologics manufacturers. In this episode of Ask the Expert, Siegfried Schmitt, vice president, Technical, at Parexel, ...
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.
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 ...
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 ...
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 ...
FDA will standardize NDCs to a 12-digit (6-4-2) structure, addressing 5-digit labeler-code constraints while creating a ...
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