UniQure, with sale of plant, outsources Hemgenix manufacturing
The layoffs stem from a long-planned shutdown of one of CSL's filling departments.
It will be the 41st edition of the Pharma-Cup, an indoor soccer tournament among German pharmaceutical companies, in which the team of Midas will participate on March 23, 2024. The venue this year will take place in Blaustein close to the city of Ulm and hosted by Teva Ratiopharm, the defending champion of last year. CSL Behring, and Teva Ratiopharm is the title defender.
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).