News & Analysis on the Clinical Development and Manufacture of Large Molecule Drugs
Generate Life Sciences is establishing a GMP facility in La Jolla, California that it says will enable end-to-end manufacturing of newborn stem cell biologics, bolstering supply and safeguarding clinical research.
Bluebird’s Lenti-D, or elivaldogene autotemcel, has won approval from the European Commission to treat children with a rare neurodegenerative disease called early cerebral adrenoleukodystrophy (CALD).
How the US Food and Drug Administration (FDA) exercises flexibility has been an important and emerging issue for the past several years.