Core Insights - CSL announced the four-year results from the pivotal HOPE-B study, confirming the long-term durability and safety of HEMGENIX for adults with hemophilia B [1][4] - HEMGENIX is the first gene therapy approved for hemophilia B, providing significant long-term bleed protection and reducing the need for routine factor IX prophylaxis [1][11] Study Results - The HOPE-B trial involved 54 adult male participants, with 51 completing four years of follow-up [2][8] - Mean factor IX levels were sustained at 37.4 IU/dL at year four, with a 90% reduction in the adjusted annualized bleeding rate (ABR) from 4.16 (lead-in) to 0.40 [2][5] - Joint bleeds decreased from a mean ABR of 2.34 at lead-in to 0.09 during year four, with 94% of patients remaining free of continuous prophylaxis [2][5] Safety Profile - No serious adverse events related to HEMGENIX were reported, and it was generally well-tolerated [3][9] - The most common treatment-related adverse events were increases in alanine transaminase (ALT), with 16.7% of participants requiring supportive care [3][16] Company Commitment - CSL is dedicated to ongoing data analyses of HEMGENIX to provide healthcare providers and patients with necessary information for informed treatment decisions [4][20] - The company has established a post-marketing registry to gather additional evidence on the long-term safety and efficacy of HEMGENIX [4][20]

Core Findings - The first season results of a randomized study indicate that adjuvanted and high-dose influenza vaccines have comparable effectiveness against PCR-confirmed influenza, with a relative vaccine effectiveness (rVE) of 1.5% [2][3][4] Study Overview - The study is a collaborative effort between CSL Seqirus and a large health system, involving approximately 480,000 individuals aged 65 and older over two seasons [4][6] - The first season enrolled 429,600 individuals, with 212,877 receiving adjuvanted inactivated influenza vaccine (aIIV) and 216,723 receiving high-dose inactivated influenza vaccine (HD-IIV) [6] - The study aims to test the hypothesis that aIIV is non-inferior to HD-IIV, with a non-inferiority margin of -20% [5] Effectiveness and Recommendations - No significant difference was found in the effectiveness of aIIV and HD-IIV for preventing hospitalization or emergency department visits for PCR-confirmed influenza, as well as for all-cause community-acquired pneumonia [2][3] - The findings support the CDC's Advisory Committee on Immunization Practices (ACIP) recommendation for preferential use of adjuvanted or higher-dose influenza vaccines for adults aged 65 and older [3] Future Directions - The second season of the study is ongoing, with pooled analyses planned after the 2024-2025 season [4][6] - The study's design allows for routine clinical practice vaccination, enhancing the real-world applicability of the findings [5]

SAN DIEGO, Oct. 17, 2024 (GLOBE NEWSWIRE) -- Travere Therapeutics, Inc., (Nasdaq: TVTX) and CSL Vifor today announced that Swissmedic has granted temporary marketing authorization for FILSPARI for the treatment of adults with primary IgA nephropathy (IgAN) with a urine protein excretion ≥1.0 g/day (or urine protein-to-creatinine ratio ≥0.75 g/g). "FILSPARI targets damage directly in the kidney and offers patients a convenient, once daily, oral, nonimmunosuppressive treatment that can provide superior result ...

Temporary marketing authorization is based on statistically significant and clinically meaningful results from the phase-III PROTECT trial ST. GALLEN, Switzerland and SAN DIEGO, Oct. 17, 2024 /PRNewswire/ -- CSL Vifor and Travere Therapeutics, Inc., (NASDAQ: TVTX) today announced that Swissmedic has granted temporary marketing authorization for FILSPARI for the treatment of adults with primary IgA nephropathy (IgAN) with a urine protein excretion ≥1.0 g/day (or urine protein-to-creatinine ratio ≥0.75 g/g). ...

Analysis from a dynamic model showed the need to increase influenza vaccination rates in the U.S. to at least 45% to avoid saturation of hospital system resources, particularly in intensive care units (ICUs).1 Results from multiple real-world evidence (RWE) studies over different seasons showed improved relative vaccine effectiveness (rVE) of cell-based vaccines compared with egg-based vaccines in preventing outpatient test-confirmed influenza across different age groups, including as young as 6 months.2,3 ...

CSL Seqirus has received a Biomedical Advanced Research and Development Authority (BARDA) award to complete the fill and finish process for additional pre-pandemic vaccines to further support the U.S. government's outbreak and preparedness response. BARDA has requested adjuvanted H5N1 pre-pandemic vaccines and additional H5N8 antigen as part of its decision to expand its portfolio of pre-pandemic vaccines. This $34 million investment is the sixth avian influenza pandemic preparedness award made to CSL Seqir ...

Results from real-world evidence (RWE) studies to be presented at OPTIONS XII show the effectiveness of cell-based and MF59® adjuvanted influenza vaccines. Results from different studies suggested improved relative vaccine effectiveness (rVE) of cell-based vaccines compared with egg-based vaccines in preventing test-confirmed influenza across different age groups, including children as young as six months.1,2 Results from a real-world study covering the 2023/24 season showed that cell-based vaccine was effe ...

Core Points - CSL Seqirus, in partnership with BARDA, will expand its MF59® adjuvant reserves to support U.S. pandemic preparedness efforts, increasing the inventory to the equivalent of 40 million doses through a $121.4 million multi-year award [1][2][3] Company Overview - CSL Seqirus is a major player in the global influenza vaccine market and is part of CSL (ASX: CSL), which has a diverse portfolio including treatments for hemophilia and immune deficiencies [7][9] - The company operates state-of-the-art production facilities in the U.S., U.K., and Australia, utilizing advanced technologies to produce a wide range of influenza vaccines [7][9] Industry Context - The MF59® adjuvant is crucial for pandemic preparedness as it enhances immune response while reducing the amount of antigen needed, thereby increasing the number of available vaccine doses [3][5] - The current public health risk from avian influenza A(H5) is low, but the CDC is monitoring the situation closely due to recent outbreaks in poultry and dairy cows [4][6] - Historical data indicates that pandemics can occur unpredictably, with the 1918 influenza pandemic being the most severe, resulting in an estimated 50 million deaths worldwide [5]

Veltassa® offers effective and well-tolerated long-term potassium control in chronic kidney disease and chronic heart failure patients 1-5 Zeria Pharmaceutical Co., Ltd. to market Veltassa® in Japan ST. GALLEN, Switzerland, Sept. 24, 2024 /PRNewswire/ -- CSL Vifor today announced that Japan's Ministry of Health and Labor Welfare (MHLW) has granted its partner, Zeria Pharmaceutical Co., Ltd. (Zeria), marketing authorization approval for Veltassa® for the treatment of adult patients with hyperkalemia, a condi ...

Core Perspective - The Mark Cuban Foundation, in collaboration with CSL, is launching a free AI bootcamp for high school students in Philadelphia, aimed at equipping the next generation with essential AI skills and knowledge [1][5]. Program Overview - The AI bootcamp features a custom curriculum focused on the latest developments in AI and Generative AI, designed to educate and inspire students [2]. - Students can choose from six tracks: healthcare, arts and entertainment, business and entrepreneurship, computer science, sports science, or education and career readiness [3]. - The program is accessible to students in grades 9-12, regardless of their prior experience in computer science or programming [3]. Target Audience - The bootcamp specifically targets underserved high school students, with a focus on recruiting girls, students of color, first-generation college students, and those from low to moderate-income households [4]. - The initiative aims to foster interest in AI among young people to prepare them for future careers [3][7]. Logistics and Support - The bootcamp will provide students with lunch, snacks, transportation assistance, and technology equipment during the program [4]. - The event is scheduled for November 2nd, 9th, and 16th, 2024, and applications are open until September 30, 2024 [5][7]. Company Background - CSL is a global biotechnology leader involved in developing lifesaving medicines and has been a partner in the AI bootcamp for four consecutive years [5][11]. - CSL operates three businesses: CSL Behring, CSL Seqirus, and CSL Vifor, providing products to patients in over 100 countries [11].