USP <231> Heavy Metals Webcast

Through this global alliance, PackGene, Weill Cornell Medicine, and GC4K, an Australian non-profit, intend to deliver a custom-tailored gene therapy solution to treat hereditary spastic paraplegia type 56, a particularly rare neurological disease.

In this episode, Hanns-Christian Mahler from ten23 Health chats about the advances in fill/finish.

Patrizia Cavazzoni, director of FDA’s Center for Drug Evaluation and Research, has announced her retirement from the agency.

In this episode, Alexander Natz from EUCOPE chats about the European Health Data Space.

With this approval, HYQVIA [Immune Globulin Infusion 10% (human) with Recombinant Human Hyaluronidase] becomes the first and only facilitated subcutaneous immunoglobulin available in Japan to treat these disorders.

The draft guidance document provides recommendations for complying with 21 CFR 211.110.