News & Analysis on the Clinical Development and Manufacture of Large Molecule Drugs
GSK’s Blenrep has proved unsuccessful in a Phase III study in multiple myeloma. The news comes two years after the drug received US Food and Drug Administration (FDA) accelerated approval.
Charles River Laboratories’ growing gene therapy manufacturing capabilities have landed it a deal with the eye disease biotech Nanoscope Therapeutics.
Japanese CDMO expands services to meet demand for parenteral drugs for global customers.
BioNTech is set to take several mRNA candidates into clinical trials over the coming months: including vaccines for shingles, malaria and tuberculosis.
Sensorion, a biotech specializing in therapies for hearing loss disorders, has been granted Rare Pediatric Disease Designation from the US Food and Drug Administration (FDA) for its lead gene therapy candidate, OTOF-GT.