The layoffs stem from a long-planned shutdown of one of CSL's filling departments.
The US Food and Drug Administration (FDA) is proposing the creation of two lists of drugs or drug categories that are difficult to compound under sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act), as well as criteria for inclusion on the lists.
With its $3.5 million price tag, CSL Behring and uniQure’s one-off hemophilia B gene therapy Hemgenix is one of the world’s most expensive therapies. On Friday, three-year follow-up from its registrational study offers a new look at the drug’s curative potential.
CSL Behring Announces Availability of Hizentra 10g Prefilled Syringe
KING OF PRUSSIA, Pa., Jan. 2, 2024 /PRNewswire/ -- CSL Behring, a business unit of global biotechnology leader CSL, today announced the availability of 4- and 5-gram vial sizes for ZEMAIRA® [Alpha1-Proteinase Inhibitor (Human)]. Previously available only in a 1-gram vial, the 4- and 5-gram packaging is significant for the Alpha-1 community as it will streamline the preparation process for ZEMAIRA and reduce waste.
Pfizer said Tuesday that US and European regulators have accepted its filings seeking approval for a gene therapy that reduces bleed rates in hemophilia B patients — and that may compete with CSL Behring’s Hemgenix.
CSL announced the first patient with haemophilia B has been treated with its recently approved gene therapy Hemgenix (etranacogene dezaparvovec).
KING OF PRUSSIA, Pa., June 20, 2023 /PRNewswire/ -- Global biotechnology leader CSL Behring today announced that the first patient has received U.S. Food and Drug Administration (FDA) approved HEMGENIX® (etranacogene dezaparvovec-drlb) for hemophilia B in the United States. HEMGENIX is the first and only gene therapy for the treatment of adults with hemophilia B who currently use factor IX prophylaxis therapy, or have current or historical life-threatening bleeding, or have repeated, serious spontaneous bleeding episodes.
CSL Behring Receives FDA Approval for Hizentra® (Immune Globulin Subcutaneous [Human] 20% Liquid) 50mL Prefilled Syringe