Cover storyWhy Quality Culture Starts with Leadership explains how leaders, not SOPs alone, shape behaviour, ownership and fearless reporting in pharmaceutical quality.
Alembic Pharma partners with DifGen to develop and manufacture complex generics in the US, reducing FDA inspection risk on foreign-made products.
Fresenius and WuXi Biologics strike a deal expanding the biosimilar pipeline to 66 molecules, with Fresenius retaining all global marketing authorizations.
Oryzon's iadademstat posts 95% ORR in Phase Ib AML data ahead of a planned Phase III trial, raising CMC readiness questions for the LSD1 inhibitor.
Merck advances OHTUVAYRE into Phase 3 for COPD exacerbation prevention, raising clinical supply and GMP planning demands for manufacturing teams.
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