News & Analysis on the Clinical Development and Manufacture of Large Molecule Drugs
A gene therapy being developed by Lexeo Therapeutics to treat cardiomyopathy caused by Friedreich ataxia, a rare neurodegenerative genetic disease, has achieved good interim results in a phase 1/2 trial.
Novo Nordisk will have to fulfill requests from the FDA regarding the manufacturing process and the indication before it can receive approval for insulin icodec.
The contract development and manufacturing organization (CDMO) Rentschler Biopharma has doubled its Current Good Manufacturing Practice (cGMP) global production capacity for complex therapies as its new production line kicks into action in the US.
Dr. Catherine Duggan, chief executive officer of the International Pharmaceutical Federation (FIP), has been at the helm since June 2018, based in The Hague.
Integrated DNA Technologies (IDT) is doubling down on its commitment to innovation with the launch of a new 25,000-square-foot synthetic biology facility in Coralville, Iowa.