Video: Risk Management of Adventitious Agent Contamination in Biopharmaceutical Products

With FDA's clearance, Kedrion can manufacture Ryplazim (plasminogen, human-tvmh), the first and only FDA-approved therapy for treating PLGD-1, at its Bolognana, Italy, site.

With this $3.6 million investment, the CDMO will strengthen its advanced labeling, automated visual inspection, and fill/finish technology.

The company will now include GMP cell-based potency assays at its Cambridge, UK, and San Diego, Calif., sites expanding its early and late phase analytical capabilities.

The new European facilities located in German, Italy, and Lithuania will specialize in drug discovery and R&D services.

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.