2021 News Releases
CSL Behring Receives Accelerated CHMP Assessment for Etranacogene Dezaparvovec for European Patients Living with Hemophilia B
KING OF PRUSSIA, PA, USA
uniQure and CSL Behring Announce Primary Endpoint Achieved in HOPE-B Pivotal Trial of Etranacogene Dezaparvovec Gene Therapy in Patients with Hemophilia B
Lexington, MA and Amsterdam, the Netherlands, King of Prussia, PA
~ Largest gene therapy study in hemophilia B achieved primary endpoint of non-inferiority in annualized bleeding rate after stable Factor IX (FIX) expression, assessed at 18 months following a single dose of etranacogene dezaparvovec
~ Etranacogene dezaparvovec also achieved secondary endpoint demonstrating statistical superiority in reduction of annualized bleeding rate compared to baseline FIX prophylactic therapy
~ Stable and durable FIX levels with mean FIX activity of 36.9 percent of normal in full study population at 18-months, compared to a mean of 39.0 percent of normal at 6 months
~ Manufacturing operations supporting process validation of etranacogene dezaparvovec successfully completed by uniQure
Clinical Trial Milestones, Investments in aQIVc and sa-mRNA Influenza Vaccines and New Strategic Collaborations Among the Highlights from CSL R&D Day
KING OF PRUSSIA, PA and MELBOURNE, AU
• CSL advances novel pipeline spanning six therapeutic areas, four scientific platforms and two businesses (CSL Behring and Seqirus)
• Seqirus Awarded BARDA contract to develop aQIVc and sa-mRNA Pandemic Influenza Vaccines
• New collaboration with the Walter and Eliza Hall Institute for Medical Research in Australia to create a Centre for Biologic Therapies
CSL Launches Annual Scholarship Program with Seven Greater Chicago Area Students Receiving Awards
CSL introduced a scholarship program for U.S. employees and their dependents as part of delivering on its promise to diversity, equity and inclusion.
CSL’s Global Role in Battling COVID-19
Here's how CSL is working around the world with academia, industry and governments to combat COVID-19
Urban League of Philadelphia Names CSL’s Elizabeth Walker to Board of Directors
KING OF PRUSSIA, Pa. and PHILADELPHIA, Pa.
Global biotech leader CSL and the Urban League of Philadelphia are working to address some of the most pressing needs in the community, including efforts to strengthen Public Health, Leadership Development, Workforce Diversity and Job Creation and Training.
The European Academy of Neurology (EAN) and Peripheral Nerve Society (PNS) Task Force Has Strongly Recommended Subcutaneous Immunoglobulin (SCIg) for CIDP Maintenance Treatment
King of Prussia, Pa.
The updated guideline empowers physicians with the confidence to expand the treatment options prescribed for CIDP patients
FDA Approves New BERINERT® (C1 Esterase Inhibitor, Human (Intravenous)) Administration Kit for Increased Patient Convenience
KING OF PRUSSIA, PA
Approval received to co-package a convenience administration kit along with the product BERINERT.
Hizentra® (Immune Globulin Subcutaneous [Human] 20% Liquid) To Be Covered Under Medicare Part B Effective July 18, Improving Access and Reducing Out-of-Pocket Costs for CIDP Patients
KING OF PRUSSIA, Pa.
Hizentra will be covered under the same Medicare benefit category as intravenous immune globulin (IVIg), but with the convenience of self-infusing at home
New Meta-Analysis of Patients with Acute Coronary Syndrome Shows Nearly Half of Recurrent Major Adverse Cardiovascular Events at One Year Occur Within the First 90 Days
KING OF PRUSSIA, Pa.
Findings signal need for novel treatment strategies to provide more protection during this high-risk, 90-day period
Lyfebulb and CSL Behring Announce the Winner of the 2021 Transplant Innovation Challenge
NEW YORK, NY, USA
Dr. Minnie Sarwal of NephroSant has been selected to receive the $25,000 Innovation Award
CSL Behring Announces Closing of Global Commercialization and License Agreement with uniQure for etranacogene dezaparvovec
KING OF PRUSSIA, PA
• Etranacogene dezaparvovec (AMT-061) is an investigational gene therapy that may potentially provide people with hemophilia B with years of functional levels of Factor IX, a blood-clotting protein that prevents excessive bleeding.
• uniQure will complete the Phase 3 HOPE-B trial and scale up manufacture for initial commercial supply under an agreed plan with CSL Behring.
Hizentra® (Immune Globulin Subcutaneous [Human] 20% Liquid) Label Update Provides New Dosing Guidelines for Physicians, Allowing for Greater Flexibility in Treating CIDP Patients
King of Prussia, Pa
The label update is based on open label extension data from the landmark PATH (Polyneuropathy And Treatment with Hizentra) study
CoVIg-19 Plasma Alliance Announces Topline Results from NIH-Sponsored Clinical Trial of Investigational COVID-19 Hyperimmune Globulin Medicine
Osaka, JAPAN and King of Prussia, Pa., USA
Phase 3 Inpatient Treatment with Anti-Coronavirus Immunoglobulin (ITAC) clinical trial sponsored and funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), did not meet its endpoints to show efficacy in adults hospitalized with COVID-19
Lyfebulb and CSL Behring Launch TransplantLyfe, a First-of-its-Kind Community Engagement Platform for Transplant Patients
• TransplantLyfe is an online community for those living with an organ transplant, their support partners and donors to share experiences, find one-on-one mentorships and help individuals feel safe as they embrace struggles unique to transplantation, regardless of their physical location.
• TransplantLyfe addresses a major unmet need for those living with organ transplantation: most notably, the support and communication gap between individuals with similar experiences in the transplant journey.