Regulatory Reform in China: Implications for Global Biopharmaceutical Companies

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

Hanns-Christian Mahler and Andrea Allmendinger from ten23 health will discuss some key aspects of biologic drug development and manufacturing.

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

With financing led by OrbiMed, Novo Holdings, and Jeito Capital, Alentis Therapeutics will develop a pipeline of Claudin-1-targeted ADCs to treat solid tumors.

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

Eisai Europe and Biogen have received a positive opinion for the monoclonal antibody therapy to be used as a treatment of adult patients with early Alzheimer’s disease.