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Orphalan plans to launch Cuvrior in early 2023. It was approved to treat Wilson’s disease, which results in excess copper in the body.

The regulatory agency has requested a quality process change for toripalimab, which is being developed to treat nasopharyngeal carcinoma.

The complete response letter identified the need for additional chemistry, manufacturing, and controls data related the drug product and manufacturing process.

Javier Gonzalez, Pharm.D., Abarca’s chief growth and commercial officer, talks about Assura, the PBM’s net cost pricing solution, which provides more predictability to drug costs and guarantees an annual fixed cost.

Ultomiris is the first approval for a long-acting C5 complement inhibitor for the treatment of generalized myasthenia gravis, a rare, chronic, autoimmune neuromuscular disease.