Video with Paul Pluta
FDA Approves Kedrion's Bolognana Plant for Production of PLGD-1 Therapeutic
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.
Pii Invests $3.6 Million to Boost Prefilled Syringe Capabilities
With this $3.6 million investment, the CDMO will strengthen its advanced labeling, automated visual inspection, and fill/finish technology.
FDA Approves PTC Therapeutics’ Gene Therapy for AADC Deficiency
The approval of eladocagene exuparvovec-tneq (Kebilidi) marks the first FDA approval for a gene therapy to treat AADC deficiency.
Lecanemab Gets Nod from CHMP for Use in Early Alzheimer’s Disease
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.
Budget Announcement Prompts UK Medicines Manufacturing Skills Centre to Emphasize Need for Skills Development
Chancellor of the Exchequer, Rachel Reeves, has announced a £520 million (US$675 million) investment for manufacturing capacity in the United Kingdom, prompting academic and industry leaders to point out that funds should be used to train personnel.
RSV Vaccine Approved for Adults 18–59
Pfizer’s bivalent RSV prefusion F vaccine has been approved by FDA to prevent lower respiratory tract disease resulting from the respiratory syncytial virus in adults 18 to 59 years of age who are at increased risk.
