CDER Drug Approvals

Under the collaboration, the companies will create and test circVec DNA–LNP formulations with an eye toward potential therapeutic applications.

The nexus between biopharmaceuticals and sustainability is seemingly far apart, however, it is increasingly recognized as an inevitable challenge. It is encouraged to take a sustainable approach to reducing the environmental impact of the production and supply of medicines while improving people's health; delivering the well-being of people and the planet. Yosuke Shimojo (Technical Value Support Section Manager, Nagase Viita) will unveil how SOLBIOTE™, a portfolio of injectable-grade saccharide excipients, would be a key for the biopharmaceutical development and achieving sustainability for a better future of the industry.

Under a £15.7 million (US$20.7 million) investment, SEKISUI has expanded its UK site for clinical-grade drug substance manufacturing.

This podcast explores the challenges of and the progress made so far by the biopharma industry toward alternative drug delivering methods for biologic drugs.

The approval of eladocagene exuparvovec-tneq (Kebilidi) marks the first FDA approval for a gene therapy to treat AADC deficiency.