Division of CSL Ltd.
Latest From CSL Behring
England’s health technology assessment body has recommended the use of Shire’s orphan drug Takhzyro for use in patients with hereditary angioedema, but only in certain circumstances and provided the company offers the product at the agreed discounted price.
Gene therapy and lambda interferon products are highlighted in the new Review Pathways section of the US FDA Performance Tracker, which keeps track of breakthrough therapy (BTD), regenerative medicine advanced therapy (RMAT), qualified infectious disease product (QIDP) designations and biosimilar submissions.
Analysts said Grifols is poised for profit margin growth after the US FDA approved its first 20% subcutaneous immunoglobulin, Xembify, for treating primary immunodeficiencies.
With only seven letters last year, Office of Prescription Drug Promotion appears to be continuing its enforcement retrenchment as agency reconsiders its approach to Rx communications.
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