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 ...

PHILADELPHIA, Sept. 17, 2024 (GLOBE NEWSWIRE) -- In an era where artificial intelligence (AI) is transforming industries and reshaping our daily lives, it is more important than ever to equip the next generation with the skills and knowledge to harness these powerful tools. The Mark Cuban Foundation, in partnership with CSL, is proud to bring the only artificial intelligence (AI) camp of its kind, free of charge, to high school students in Philadelphia. Applications for the no-cost bootcamp are closing Sept ...

Industry Collaboration and Membership - Accumulus Synergy welcomes CSL as its first member organization, marking significant progress in advancing critical therapies globally [1] - The membership model aims to shape regulatory policy, raise awareness of global harmonization, and drive digital transformation to accelerate therapies worldwide [2] - Membership is open to life sciences organizations, health associations, private/non-profit foundations, and other institutions, offering access to resources, thought leadership, and networking opportunities [4] Strategic Vision and Impact - Accumulus Synergy is described as a catalyst for change, pioneering an industry paradigm shift for regulatory harmonization and digital transformation [3] - The collaboration between Accumulus and CSL is expected to amplify their collective impact and drive positive change on a global scale [2] - The focus is on advancing opportunities for regulatory data convergence, data harmonization, and digital transformation [5] Company Overviews - Accumulus Synergy is a global nonprofit industry association developing a transformative data exchange platform to enhance collaboration between life sciences organizations and global Regulatory Authorities [6] - CSL is a global biotechnology company with a portfolio of lifesaving medicines, vaccines, and therapies, operating in over 100 countries with 32,000 employees [7] Media Contact - Media inquiries can be directed to Allison Mari at Accumulus Synergy [8]