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December 03, 2024
A new platform allowing market authorization holders to report drug shortages has gone live.
The 340B program is under greater scrutiny with more transparency for drug access being demanded by industry.
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November 29, 2024
The acquisition will provide Roche with access to Poseida’s GMP manufacturing capabilities and R&D portfolio assets, including cell therapy candidates.
November 28, 2024
Through this acquisition, the German CDMO expands its global network and adds aseptic fill/finish and lyophilization expertise to its sterile manufacturing capabilities.
November 23, 2024
FDA's approval will allow Kedrion to manufacture Ryplazim (plasminogen, human-tvmh), the only FDA-approved therapy for treating PLGD-1, at facility in Bolognana, Italy.
The Thousand Oaks, Calif., cell therapy manufacturing facility now houses new production suites, updated development labs, and more after expansion.
The $3.6 million investment will allow the CDMO to boost its advanced labeling, automated visual inspection, and fill/finish capabilities.
November 22, 2024
The company has expanded its early and late phase analytical capabilities by including GMP cell-based potency assays at its sites in Cambridge, UK, and San Diego, Calif.
Sanofi will use this investment to increase its antibody bioproduction at its site in Lyon Gerland, France.