Regulatory Requirements for Biologic Drug Development

Using splicing technology, the new company aims to innovate safer and more effective RNA therapies for severe genetic diseases.

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

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.

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

Under the agreement, the companies will advance development of IBI3009, Innovent’s ADC candidate, which has received IND approvals in the US, China, and Australia.

The comment period for the Federal Register Notice, “Evaluating the Immunogenicity Risk of Host Cell Proteins in Follow-on Recombinant Peptide Products: Establishment of a Public Docket: Request for Information and Comments”, has been reopened by FDA until March 3, 2025.