News & Analysis on the Clinical Development and Manufacture of Large Molecule Drugs
Thermo Fisher Scientific says its is leveraging the company’s global infrastructure to offer end-to-end services aimed at speeding up the introduction of cell and gene therapies.
The International Society for Cell & Gene Therapy (ISCT) has established a task force to ensure that the CGT field advances in an ethical manner and that the expanded access route is being used for its intended purpose.
The US Food and Drug Administration (FDA) has granted commercial licensure approval for Novartis’ Durham, N.C. site, a multi-product gene therapy manufacturing facility, which will start producing Zolgensma immediately.
The FDA has released two draft guidance documents: for human gene therapy products incorporating human genome editing, and for CAR T cell products.