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 ...
Deal terms include $1.1B upfront and up to $400M milestones, positioning Novartis to internalize an N‑myristoyltransferase inhibitor payload platform for next-generation ADC development. Myricx’s lead ...
FDA will standardize NDCs to a 12-digit (6-4-2) structure, addressing 5-digit labeler-code constraints while creating a ...
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, ...
Lonza will add commercial-scale manufacturing for highly complex HPAPIs and ADC payload linkers at Visp, expanding capacity ...
FDA cleared Tregzi to improve chronic GVHD-free survival, representing a non-pharmacologic strategy to reduce chronic GVHD while supporting immune reconstitution after allogeneic transplantation.
AI is reshaping GMP documentation and quality workflows, but human accountability remains non-negotiable, and the regulatory consequences for over-relying on AI are real. The second episode of ...
Priority review follows phase 3 placebo-controlled evidence across SatraGO-1/2, presented at ASOPRS 2025, demonstrating improvements in proptosis, inflammation, diplopia, and patient-reported outcomes ...
BioPhorum, a global forum for biopharmaceutical industry collaboration, has formed a new working group aimed at accelerating innovation across small molecule manufacturing. 1 The Synthetic Molecule ...
Cohort composition spans sterile small molecules, APIs, commercial cell-culture biologics, rare-disease drug substance, and CGT capacity across NY, NJ, IN, and NC manufacturing hubs. Eligibility ...
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