Welcome to our dedicated page for Csl news (Ticker: CSLLY), a resource for investors and traders seeking the latest updates and insights on Csl stock.
CSL Limited ADR news reflects developments from a global biopharma company focused on plasma-derived therapies, vaccines and biotechnology medicines. Recurring updates cover CSL Behring, CSL Seqirus and CSL Vifor activities, including hemophilia and immune-deficiency therapies, influenza vaccines, iron-deficiency and nephrology treatments, and hereditary angioedema products.
Company news also includes clinical data and regulatory decisions for products such as HEMGENIX, ANDEMBRY and FILSPARI, manufacturing investments tied to plasma-therapy capacity and advanced production processes, and ADR program administration for the U.S. over-the-counter security.
Terumo Blood and Cell Technologies and CSL Plasma have announced a collaboration to develop a new plasma collection platform at CSL Plasma's U.S. collection centers. A clinical trial for the investigational plasmapheresis device commenced in April 2021. The introduction of this platform is contingent on U.S. FDA device clearance, with further details to follow. Plasma collected plays a crucial role in therapies for life-threatening conditions, including immune deficiencies and hemophilia. CSL Plasma operates over 300 centers globally, providing vital therapies to patients.
Seqirus has published new research in Vaccines showing that its cell-based quadrivalent influenza vaccine (QIVc) significantly reduced hospitalizations and emergency room visits compared to egg-based vaccines (QIVe) during the 2018/19 U.S. influenza season. Analysis indicated annual savings of $461 per vaccinated individual with QIVc. More than 20 million doses of QIVc were administered in the U.S., highlighting its public health impact. The study supports QIVc's effectiveness, especially against respiratory complications, while indicating potential cost benefits for healthcare systems.
Seqirus has received FDA approval for its FLUCELVAX® QUADRIVALENT influenza vaccine, expanding its use to individuals aged two and older, previously approved for those four and older. The approval is based on efficacy data showing a strong immune response in children aged ≥2 to 18 years during three influenza seasons. The vaccine, which incorporates a cell-based production process, aims to reduce strain mismatch and improve seasonal flu prevention. FLUCELVAX QUADRIVALENT will be available for the upcoming 2021/22 flu season, enhancing public health efforts amid ongoing pandemic challenges.
CSL Behring announced FDA approval for HAEGARDA® (C1 Esterase Inhibitor Subcutaneous) to prevent hereditary angioedema (HAE) attacks in patients aged 6 and older. HAE is a rare genetic disorder affecting about 1 in 50,000 people in the U.S. HAEGARDA, first approved in 2017, now offers a subcutaneous treatment option that reduces attack frequency by an average of 95%. The approval is based on successful results from the COMPACT trials, including safety data for pregnant women. This expands treatment options for pediatric patients, addressing unmet medical needs in the HAE community.
Seqirus released new real-world evidence indicating that its MF59® adjuvanted trivalent influenza vaccine (aTIV) outperformed standard-dose non-adjuvanted vaccines in preventing influenza-related medical visits and hospitalizations in adults aged 65 and older during the 2017/18 U.S. influenza season. The study also found comparable effectiveness between aTIV and high-dose trivalent vaccines. Economic analysis showed comparable healthcare costs for both aTIV and high-dose vaccines. This data emphasizes the importance of enhanced vaccines for vulnerable populations, particularly amid the COVID-19 pandemic.
Seqirus has published real-world evidence demonstrating the superiority of its cell-based quadrivalent influenza vaccine (QIVc) over standard egg-based vaccine (QIVe-SD) in preventing influenza-related hospitalizations during the 2017/18 flu season. The study, published in Vaccine, involved over 3 million subjects and showed QIVc resulted in lower healthcare resource utilization and hospitalizations. This significant data supports the CDC's annual vaccination recommendation and underscores the importance of QIVc, particularly as COVID-19 persists, emphasizing the urgent need for effective influenza prevention.