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

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 ...

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, ...

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.

Lonza will add commercial-scale manufacturing for highly complex HPAPIs and ADC payload linkers at Visp, expanding capacity ...

FDA will standardize NDCs to a 12-digit (6-4-2) structure, addressing 5-digit labeler-code constraints while creating a ...

The complexities of tech transfer may be overcome by data-driven approaches, digital tools, and effective communication. Outsourcing in the biopharma and pharma industries is on the rise, driven by ...

A second CRL was issued exclusively for unresolved CMC compliance deficiencies at the drug-substance contract manufacturer, despite no FDA concerns regarding efficacy, safety, or data sufficiency.

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 ...