CSL develops and delivers biotherapies and influenza vaccines, focusing on rare and serious diseases. Their products include plasma-derived and recombinant therapies, which are created through extensive research and development. CSL serves a wide range of clients, including healthcare providers and governments, across the Americas, Asia Pacific, and Europe. What sets CSL apart from competitors is its comprehensive portfolio and commitment to addressing rare diseases, alongside a strong emphasis on diversity and inclusion within its workforce. The company's goal is to save lives and protect health through its innovative therapies and vaccines.

Biotechnology

Healthcare

If approved, garadacimab will be the first and only once-monthly treatment inhibiting factor XIIa to prevent attacks in HAE patients – a community CSL has been serving for more than 40 yearsMARBURG, Germany, Dec. 13, 2024 /PRNewswire/ -- Global biotechnology leader CSL (ASX:CSL; USOTC:CSLLY) today announced the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending granting a marketing authorization for garadacimab as a once-monthly prophylactic treatment for hereditary angioedema (HAE) in adult and adolescent patients aged 12 years and older. Garadacimab is a monoclonal antibody that targets activated factor XII (factor XIIa), a plasma protein that plays a key role in attacks of swelling in people with HAE, thereby inhibiting the HAE cascade at the top to prevent HAE attacks. The final European Commission (EC) decision is expected in Q1 2025."CSL has a longstanding and relentless patient-focused approach to developing transformational medicines in areas of unmet need. This CHMP decision brings us closer to offering an innovative treatment to patients living with HAE, which is a debilitating and potentially life-threatening condition," said Emmanuelle Lecomte-Brisset, Senior Vice President and Head of Global Regulatory Affairs, CSL. "We look forward to making this therapy available to patients in Europe."Attacks of HAE are often painful and can spread to multiple sites of the body, including the abdomen, larynx, face, and extremities

Csl Receives Positive Chmp Opinion For Garadacimab In Hereditary Angioedema (Hae)

Biomedical Advanced Research and Development Authority (BARDA) and CSL Seqirus will expand their reserves of MF59® adjuvant to the equivalent of 40 million doses as part of the National Pre-Pandemic Influenza Vaccine Stockpile (NPIVS). The multi-year $121.4 million award from BARDA is the fifth avian influenza pandemic preparedness award for CSL Seqirus.SUMMIT, N.J., Sept. 25, 2024 /PRNewswire/ -- CSL Seqirus, a business of CSL (ASX: CSL), announced today that through its public-private partnership with the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS), the company will expand its Vendor Managed Inventory (VMI) program for its proprietary MF59® adjuvant. This decision will further support the U.S. government's pandemic preparedness efforts. MF59® adjuvant is an important part of pandemic preparedness planning as it reduces the amount of antigen required to produce an immune response, increasing the number of vaccine doses.1,2 When combined with influenza antigens in a vaccine, MF59® adjuvant is designed to enhance and broaden the body's immune response by creating a broad, cross-reactive antibody response.3,4,5

Csl Seqirus, A Global Leader In Pandemic Preparedness, Announces Fifth Barda Award In Response To Avian Influenza Outbreak

“Curing” Bleeding with Artificial PlateletsA lot of deaths from injuries and accidents are linked to blood loss. While not as discussed as cancer, cardiovascular, or genetic diseases, this is a segment of medicine that can greatly benefit from more advanced technology to save lives.In current ER treatment, transfusion of platelets, the cells responsible for coagulation, is often required to manage bleeding.The way platelets work is by responding to a signal sent by the body of an injury, making the platelets travel to the injury site. Once arrived, the platelets will clump together to form a clot helping to stop the bleeding.The clot itself is formed by the agglomeration of platelets and fibrin, a fibrous protein present in the bloodstream. The whole process is also mediated by no less than 13 different coagulation factors .However, the problem is that the storage of platelet transfusions is difficult, reducing its utility in a pre-hospital setting. Among the issues are “ limited donor availability, difficult portability and storage, high bacterial contamination risks, and very short shelf life (~5-7 days) ”.Platelets remain the “final frontier” of blood component transfusion in the pre-hospital setting, and data supporting improved outcomes with early platelet transfusion in massive hemorrhage strongly support the rationale to move platelet transfusion forward along with PRBCs and plasma. Bioinspired Artificial Platelets: Past, Present and Future.Bleeding from a traumatic injury will never stop being dangerous, no matter what other advancements we make in genetics, cell biology, or artificial organs

Synthetic Biomaterials May Become Crucial In Emergency Trauma Situations

KING OF PRUSSIA, Pa. SAN DIEGO--(BUSINESS WIRE)--Global biotechnology leader CSL (ASX:CSL; USOTC:CSLLY) and Arcturus Therapeutics (Nasdaq: ARCT) today announce Nature Communications has published results from an integrated phase 1/2/3a/3b study evaluating the safety, immunogenicity, and efficacy of ARCT-154, a novel self-amplifying (sa-mRNA) COVID-19 vaccine and the world’s first approved sa-mRNA COVID-19 vaccine. The results demonstrate that two 5 μg doses of ARCT-154, sa-mRNA vaccine, were well-tolerated, immunogenic and provided significant protection against multiple strains of COVID-19. The efficacy of ARCT-154 against severe COVID-19 was 100 percent in healthy persons aged 18-59 and more than 90 percent in persons at risk of severe consequences of the disease due to co-morbidities or older age. “The results published in Nature Communications demonstrate the efficacy and tolerability of ARCT-154 and add to a growing body of evidence that our sa-mRNA vaccine has the potential to provide significant protection against the pervasive virus, reinforcing our promise to protect public health,” said Jon Edelman, M.D., Senior Vice President, Vaccines Innovation Unit, CSL

Nature Communications Publishes Pivotal Data Demonstrating Efficacy And Tolerability Of Csl And Arcturus Therapeutics’ Covid-19 Vaccine

A real-world evidence (RWE) study recently published in Open Forum Infectious Diseases (OFID) examined three consecutive U.S. flu seasons in the United States. The study suggests that cell-based quadrivalent influenza vaccine (QIVc) may have the potential to be more effective than egg-based vaccines (QIVe) in preventing test-confirmed influenza. 1The study results reveal that the relative vaccine effectiveness of QIVc versus QIVe in prevention of test-confirmed influenza was at least 10% higher across three consecutive flu seasons, 2017–2020.1SUMMIT, N.J., May 2, 2024 /PRNewswire/ -- CSL Seqirus, a business of CSL (ASX: CSL), today announced a real-world evidence (RWE) study recently published in Open Forum Infectious Diseases (OFID), showing that a cell-based quadrivalent influenza vaccine (QIVc) prevented more test-confirmed influenza cases among individuals 4–64 years of age compared with the egg-based quadrivalent influenza vaccine (QIVe) over three consecutive U.S. influenza seasons (2017–2020).1 These data add to the growing wealth of evidence supporting the benefits of cell-based influenza vaccines.The study collected RWE from 31,824, 33,388, and 34,398 subjects in the 2017–2018, 2018–2019, and 2019–2020 seasons, respectively.1 Findings show a higher relative effectiveness of QIVc over QIVe in the prevention of test-confirmed influenza, with estimated relative vaccine effectiveness (rVE) of 14.8% for the 2017–18 season, 12.5% for 2018–19, and 10.0% for 2019–20.1 rVE means the effectiveness of one vaccine relative to another."This study exemplifies the value of RWE in generating valuable insights into the effectiveness of influenza vaccines," said Alicia N. Stein, Director, Real World Evidence, Center for Outcomes Research and Epidemiology, CSL Seqirus

Recently Published Real-World Evidence Study Shows Effectiveness Of Cell-Based Quadrivalent Influenza Vaccine Over Three Seasons

MELBOURNE, Australia, April 18, 2024 /PRNewswire/ -- Australia's newest biotech incubator Jumar Bioincubator has officially opened its doors and revealed the first 16 innovative early-stage ventures to take up residency in its much-awaited Melbourne-based facility at an event officiated by Lord Mayor, Sally Capp AO.The state-of-the-art facilities, infrastructure, and support offered by Jumar creates a world-class hub for biotech innovation translation, research commercialisation, and talent development that will help to progress discoveries towards real-world patient treatments.Jumar plaque unveiling (L-R) Sally-Ann Williams, Lauren Morrey, Ken Jefferd, Mayor Sally Capp, Andrew Nash, Anne-Laure Puaux, Camille ShanahanIt aims to build "Australia's next CSL" by capitalising on the talent and capabilities of the local biotech research community to support the next homegrown global success story, and create a critical mass of entrepreneurial-skilled scientists who have the ability to run successful biotech companies.The official opening on 16 April 2024 was hosted by founding partners CSL , WEHI , and The University of Melbourne (UoM), as well as initial investor Breakthrough Victoria and operator Cicada Innovations .VIP guests, including biotech leaders from across government, academia, business, and research, were introduced to a number of "born global" biotech residents working on health issues across pharmaceuticals, diagnostics, medical devices, bioinformatics, health-related AI and more:Denteric is developing a therapeutic vaccine for the one billion people (one third of all adults) globally suffering from periodontal gum disease - a disease that is also associated with diabetes, heart disease, rheumatoid arthritis, dementia, and certain cancers. Investment from Brandon Capital, CSL, and UoM is now funding the development of safe and convenient periodontitis treatments that are much less painful, more reliable, and more effective.is developing a therapeutic vaccine for the (one third of all adults) globally suffering from periodontal gum disease - a disease that is also associated with diabetes, heart disease, rheumatoid arthritis, dementia, and certain cancers. Investment from Brandon Capital, CSL, and UoM is now funding the development of safe and convenient periodontitis treatments that are much less painful, more reliable, and more effective. Ovulation bio-sensing startup Symex Labs has developed a wearable "lab-on-a-chip" solution that provides continuous "set-and-forget" monitoring of hormones to more conveniently and effectively predict ovulation for people wanting to conceive. It is also now developing a biosensor-based home-use device to replace blood tests associated with IVF treatments. This could have an incredible impact on the 17.5 percent of the global adult population – roughly 1 in 6 worldwide – that experiences infertility.has developed a wearable "lab-on-a-chip" solution that provides continuous "set-and-forget" monitoring of hormones to more conveniently and effectively predict ovulation for people wanting to conceive

Mini Brains And Lab-On-A-Chip Wearables: Jumar Bioincubator Officially Begins Its Mission To Build "Australia'S Next Csl"

CSL Behring Signs First Commercial Agreement in Austria to Fund Haemophilia B Gene Therapy HEMGENIX®MARBURG, GERMANY – March 4, 2024 – Global biotechnology leader CSL Behring (ASX: CSL) today announced that a commercial contract has been signed to fund HEMGENIX® (etranacogene dezaparvovec) in Austria, with the option to access a dedicated fund, established by the provinces for specialised medicines. This is the first commercial agreement in Austria for HEMGENIX® and will enable access to the gene therapy for haemophilia B patients.HEMGENIX® is the first and only one-time gene therapy approved in Austria for the treatment of severe and moderately severe haemophilia B (congenital factor IX deficiency) in adult patients without a history of factor IX inhibitors.1This pioneering funding solution plays an important role in the broader paradigm shift being seen in the treatment of haemophilia B. Expanded access to HEMGENIX® will continue to progress the move away from lifelong intravenous factor IX infusions, which can significantly impact the quality of life and wellbeing of patients.2“Over the past two years we have worked diligently with all relevant stakeholders to enable access to HEMGENIX®,” said Dr Beate Pettinger-Natmeßnig, General Manager Commercial Operations Austria, CSL Behring. “The agreement signed for HEMGENIX® demonstrates the Austrian healthcare system's commitment to provide access to gene therapy and to break new ground in the financing of advanced therapy medicinal products."With this agreement in place, eligible patients in Austria with severe and moderately severe haemophilia B can be treated with HEMGENIX® at the Haemophilia Comprehensive Care Centre at the Medical University of Vienna, the first HUB-centre in the country.“It is hugely encouraging to see pioneering funding solutions being developed and realised across Europe,” said Dr Lutz Bonacker, SVP and General Manager Commercial Operations Europe, CSL Behring. “The new commercial agreement in Austria is a strong signal to how innovative and collaborative thinking can bring a transformative impact for patients and their loved ones, for whom there is still significant unmet need in haemophilia B.”About Haemophilia BHaemophilia B is a life-threatening rare disease. People with the condition are particularly vulnerable to bleeds in their joints, muscles, and internal organs, leading to pain, swelling, and joint damage

Csl Behring Signs First Commercial Agreement In Austria To Fund Haemophilia B Gene Therapy Hemgenix®

Strong CSL Behring portfolio growth especially IgFINANCIAL HIGHLIGHTS4Revenue $8.05 billion , up 11% at CC 3, up 11% at CC NPAT $1.90 billion 1 , up 17%, up 17% NPAT $1.94 billion 1 at CC 3 , up 20%at CC , up 20% NPATA $2.02 billion 1,2 , up 11%, up 11% NPATA $2.06 billion 1,2 at CC 3 , up 13%at CC , up 13% NPATA 1,2 earnings per share $4.18 2 , up 11% NPATA 1,2 earnings per share $4.26 at CC 3 up 13%earnings per share , up 11% Interim dividend 5 of US$1.19 per share Converted to Australian currency, the interim dividend is approximately A$1.81 per share, up 12%of per share Guidance reaffirmed – FY24 NPATA2,4 anticipated to be in the range of approximately $2.9 billion to $3.0 billion 2 at CC3MELBOURNE, Australia, Feb. 13, 2024 /PRNewswire/ -- CSL Limited (ASX:CSL; USOTC:CSLLY) today announces a reported net profit after tax of $1.90 billion1 for the 6 months ended 31 December 2023, up 20% on a constant currency basis3. Underlying profit (NPATA) was $2.02 billion1,2, up 13% on a constant currency basis to $2.06 billion1,2,3.Dr. Paul McKenzie, CSL's Chief Executive Officer and Managing Director said, "Our strong first-half result for the 2024 financial year was driven by CSL Behring's exceptional performance across its portfolio, especially immunoglobulins. The plasma initiatives we have implemented are starting to drive gross margin recovery."CSL Seqirus achieved solid growth in a challenging season. Its portfolio of differentiated products outperformed the market."For CSL Vifor we are well prepared for the transitioning iron market."PERFORMANCECSL BehringTotal revenue was $5,238 million, up 14%3 when compared to the prior comparable period.Immunoglobulin (Ig) product sales of $2,757 million, increased 23%3 with strong growth recorded across all geographies driven by global plasma supply and patient demand.PRIVIGEN® / INTRAGRAM® (Immune Globulin Intravenous (Human), 10% Liquid) sales grew 27%3 as the momentum from the prior year continued in improving product availability and patient diagnosis rates.HIZENTRA® (Immune Globulin Subcutaneous (Human), 20% Liquid) sales were up 18%3 driven by patient diagnosis rates

Half Year Reported Npata Us$2 Billion¹,² Up 13% At Constant Currency³

KING OF PRUSSIA, Pa. SAN DIEGO--(BUSINESS WIRE)--Global biotechnology leader CSL (ASX:CSL; USOTC:CSLLY) and Arcturus Therapeutics (Nasdaq: ARCT) today announced the results of a follow-up analysis of a Phase 3 study evaluating a booster dose of ARCT-154, the world's first approved self-amplifying messenger RNA (sa-mRNA) COVID-19 vaccine, compared to a conventional mRNA COVID-19 vaccine. ARCT-154 was administered at one-sixth the dose of Comirnaty® (5 μg vs 30 μg, respectively). The new analysis at 6 months post-vaccination shows that ARCT-154 induces a longer immune response as compared to Comirnaty for both the original Wuhan strain and Omicron BA.4/5 variant and an advantage in antibody persistence. “These results further support sa-mRNA’s differentiating attribute to provide prolonged protection against COVID-19 at lower doses,” said Jonathan Edelman, M.D., Senior Vice President, Vaccines Innovation Unit, CSL. “Protecting the global public from viral respiratory diseases remains a top priority for us, and we look forward to continuing to collect and share data at the twelve-month post-booster mark.”

New Covid-19 Sa-Mrna Results From Csl And Arcturus Therapeutics Demonstrate Longer Duration Of Immunity Compared To Conventional Covid-19 Mrna Vaccine Booster

KING OF PRUSSIA, Pa. SAN DIEGO--(BUSINESS WIRE)-- Global biotechnology leader CSL Behring (ASX:CSL; USOTC:CSLLY) and Arcturus Therapeutics, Inc. (Nasdaq: ARCT) today announced the results of a follow-up analysis of a Phase 3 study evaluating a booster dose of ARCT-154, the world's first approved self-amplifying messenger RNA (sa-mRNA) COVID-19 vaccine, compared to a conventional mRNA COVID-19 vaccine. ARCT-154 was administered at one-sixth the dose of Comirnaty® (5 μg vs 30 μg, respectively).The new analysis at 6 months post-vaccination shows that ARCT-154 induces a longer immune response as compared to Comirnaty for both the original Wuhan strain and Omicron BA.4/5 variant and an advantage in antibody persistence.“These results further support sa-mRNA’s differentiating attribute to provide prolonged protection against COVID-19 at lower doses,” said Jonathan Edelman, M.D., Senior Vice President, Vaccines Innovation Unit, CSL. “Protecting the global public from viral respiratory diseases remains a top priority for us, and we look forward to continuing to collect and share data at the twelve-month post-booster mark.”“This data, coupled with the initial Phase 3 results and approval in Japan late last year, show that this innovative vaccine technology has the potential to provide significant advancements over conventional mRNA vaccines including prolonged protection at lower doses,” said Pad Chivukula, Ph.D., Chief Scientific Officer of Arcturus Therapeutics.ARCT-154 Six-Month Data ReportThis randomized, double-blind, active-controlled study, conducted at 11 sites in Japan assessed the immunogenicity of ARCT-154 and Comirnaty® at one, three- and six-months post-booster. Participants who displayed seropositivity for SARS-CoV-2 N-protein on Days 1, 29, 91 or 181 were considered indicative of recent COVID-19 infection and therefore, were progressively excluded from the analysis, leaving 332 and 313 participants in ARCT-154 and Comirnaty® groups, respectively, eligible for inclusion at the six-month immunogenicity evaluation.At baseline, participants in both groups had similar geometric mean titers (GMTs) surrogate virus neutralizing antibodies against Wuhan-Hu-1 strain (GMT ratio was 0.94 (95% CI 0.78-1.13))

New Covid-19 Sa-Mrna Results From Csl And Arcturus Therapeutics Demonstrate Longer Duration Of Immunity Compared To Conventional Covid-19 Mrna Vaccine Booster - February 5, 2024

Develops biotherapies and influenza vaccines

CSL

Develops biotherapies and influenza vaccines

CSL

Develops biotherapies and influenza vaccines

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