Lonza will add commercial-scale manufacturing for highly complex HPAPIs and ADC payload linkers at Visp, expanding capacity ...
US opens Section 301 probe into Germany's drug pricing, threatening tariffs that could disrupt API supply chains and reshape ...
FDA authorized the first generic baloxavir marboxil, a cap-dependent endonuclease inhibitor, expanding single-dose influenza ...
As Eli Lilly moves forward with its $3.5 billion injectable medicines facility in the Lehigh Valley region of Pennsylvania, ...
A Class II recall was initiated for duloxetine lots after N-nitroso-duloxetine exceeded FDA intake limits, reflecting low acute clinical risk but regulatory nonconformance. Nitrosamine issues ...
In this episode of Drug Digest, experts from Sanofi, GxP Frame, and Open Biopharma explain how AI is transforming drug discovery, manufacturing, and workforce strategy and how strategic partnerships ...
This episode of Pharma Fundamentals explains the difference between a quality system for biologics compared with small-molecule drugs and the Parenteral Drug Association’s revision to Technical Report ...
Transaction diligence increasingly stress-tests supply chain integrity across the full patient journey for cell and gene ...
In biologics development, there is a constant tension between moving quickly and making the right decisions early. As programs progress toward the clinic, early cell line development plays a central ...
FDA’s durable expectation is that AI outputs can aid drafting, but must be reviewed and cleared by an authorized QU ...
Through consideration of the ionic equilibria of acids and bases, one may readily calculate the formation constant of a salt species solely on the basis of knowledge of the pKA value of the acid and ...
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