Oxford BioMedica saw its share price jump 21% after the US FDA approved Kymriah, the gene modified cell therapy made with the firm’s lentiviral vectors.
CSL Behring will launch itself into the stem cell gene therapy through the acquisition of Calimmune, adding a preclinical candidate and two manufacturing efficiency technologies.
The US FDA has warned a Florida-based clinic and seized vials of a smallpox vaccine in California used to create an unapproved product in a crackdown against "unscrupulous" stem cell firms.
The US FDA has approved its sixth biosimilar and second version of AbbVie’s best-selling monoclonal antibody Humira (adalimumab): Cyltezo, made by Boehringer-Ingelheim.
Industry is feeling the low yield and high cost limitations of the CHO cell line and must look to alternatives to make next-generation biological products, says fungal-based protein expression firm Dyadic International.
Lonza will feed demand for its drug quality testing and formulation capabilities through an expansion at its Drug Product Services site in Basel, Switzerland.
Imraldi becomes the second version of AbbVie’s best-selling biologic Humira (adalimumab) to be approved and the fourth biosimilar success for Samsung Bioepis in Europe.
