News & Analysis on the Clinical Development and Manufacture of Large Molecule Drugs
BioMarin Pharmaceutical has opened the expansion of its manufacturing plant at Shanbally, Co. Cork: with the site now able to provide end-to-end manufacturing for a number of the company’s commercial products.
Avidity Biosciences, a biopharmaceutical company developing a new class of RNA therapeutics called Antibody Oligonucleotide Conjugates (AOCs), today announced that the US Food and Drug Administration (FDA) has granted Fast Track designation to AOC 1044.
Moderna will explore next generation technologies - including quantum computing and artificial intelligence - to advance and accelerate mRNA research via a new partnership with IBM.
bluebird bio has announced the submission of a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for lovotibeglogene autotemcel (lovo-cel) gene therapy in patients with sickle cell disease (SCD).