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CSL LTD SP/ADR (CSL) is a global biotechnology company known for its innovative therapies in iron deficiency and nephrology. Headquartered in St. Gallen, Switzerland, CSL Vifor, a division of CSL, focuses on strategic global partnerships, innovative pharmaceuticals, and precision healthcare solutions. Their portfolio includes Ferinject, an IV iron therapy with marketing authorization in 87 countries as of 2024, addressing iron deficiency anemia and heart failure in adults and pediatric patients. With a workforce of 32,000, CSL delivers life-saving products worldwide, striving to improve patients' quality of life.
CSL announced positive preclinical results for its self-amplifying mRNA (sa-mRNA) influenza vaccine candidates, showing a strong immune response against A(H5N1) and A(H1N1) strains. Published in Molecular Therapy – Methods and Clinical Development, the study indicated that a low dose (0.01 µg) of the A(H5N1) candidate induced significant antibody production and T-cell responses. CSL plans to initiate Phase 1 clinical trials soon, highlighting the sa-mRNA technology's potential to enhance vaccine efficacy and reduce doses required during pandemic settings.
CSL Seqirus presented significant data on influenza's impact on healthcare at the OPTIONS XI conference in Belfast from September 26-29, 2022. The WHO estimates up to 650,000 seasonal influenza deaths globally, with up to 52,000 deaths and 710,000 hospitalizations annually in the U.S. A study suggests raising U.S. vaccination rates from 45% to at least 70% to prevent overwhelming hospital systems during co-circulation with COVID-19. Another analysis in Italy showed an average of 8,892 influenza cases among 150,000 children under 14 each season, highlighting the disease's pediatric burden.
CSL Seqirus announced findings from four real-world studies presented at OPTIONS XI, demonstrating the effectiveness of cell-based and adjuvanted influenza vaccines in reducing influenza-related hospitalizations and costs. Notably, data showed that the MF59-adjuvanted FLUAD vaccine decreased hospitalizations in adults aged 65 and older, while the FLUCELVAX QUADRIVALENT vaccine was more effective for adults aged 18 to 64. The predictive modeling indicated potential savings of 24,000 acute hospital beds during high flu seasons, emphasizing the importance of vaccination rates to avoid healthcare resource saturation.
CSL has inaugurated its new EUR 150 million research and development (R&D) facility in Marburg, Germany, marking the company’s largest R&D site globally with over 500 employees. The facility, covering approximately 40,000 square meters, aims to foster collaboration with scientific partners and enhance innovation. Designed with sustainability in mind, the building meets strict environmental standards and incorporates advanced technologies. CEO Paul Perreault emphasized the significance of Marburg in CSL's history and future, aligning with the company's commitment to biotechnology.
CSL Seqirus announced it will present over 20 data sets at the OPTIONS XI conference from September 26-29, 2022, in Belfast, United Kingdom. The presentations will focus on seasonal and pandemic influenza studies, including an oral presentation on influenza risk factors. A symposium titled "INFLUENZA: TIME FOR A DIFFERENT PERSPECTIVE?" will address pandemic preparedness and the role of neuraminidase. The company aims to advance vaccine technology to improve community protection against influenza.
CSL Plasma, headquartered in Boca Raton, Florida, is offering free flu vaccination vouchers to plasma donors who complete two donations within a calendar month. Starting September 2022, donors can receive vouchers redeemable at Walgreens locations. This initiative, in its third year, aims to enhance community health and acknowledges the vital role of plasma donations in treating rare diseases. The program will conclude in December 2022, with vouchers expiring on December 31, 2022.
The European Medicines Agency (EMA) has accepted the Conditional Marketing Authorization (CMA) application for sparsentan, a treatment for IgA nephropathy (IgAN)
If approved, sparsentan will be a first-in-class non-immunosuppressive therapy addressing a significant unmet need in Europe. The application is supported by positive interim results from the PROTECT Study, showing a 49.8% reduction in proteinuria compared to 15.1% in controls, indicating strong efficacy.
U.S. District Court for the District of Delaware ruled in favor of Vifor Fresenius Medical Care Renal Pharma (VFMCRP), confirming that Teva Pharmaceuticals infringes the patent for Velphoro (sucroferric oxyhydroxide). This ruling protects VFMCRP's formulation patent, set to expire in July 2030. Previous disputes with other ANDA filers regarding Velphoro have been settled, allowing them to launch generics on agreed dates. VFMCRP is actively defending its intellectual property to sustain its market position.
Kapruvia® (difelikefalin) has received approval from the Swiss Agency for Therapeutic Products for treating chronic kidney disease (CKD)-associated pruritus in hemodialysis patients. This follows approvals from agencies in the U.S., Canada, and Europe. The approval is backed by positive results from pivotal phase-III trials, including KALM-1 and KALM-2, and 32 supportive studies. Regulatory decisions in Australia and Singapore are anticipated soon. The therapy aims to address a significant unmet medical need for those suffering from moderate-to-severe pruritus, potentially improving their quality of life.
Vifor Fresenius Medical Care Renal Pharma announces that NICE has recommended Tavneos® for treating severe granulomatosis polyangiitis (GPA) and microscopic polyangiitis (MPA) in adults in England, Wales, and Northern Ireland. This oral therapy follows MHRA authorization in May 2022. Clinical trials showed Tavneos® met primary endpoints, offering a new treatment option with a favorable safety profile. The launch is expected shortly, marking a significant advancement in addressing the unmet medical needs of AAV patients.
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