OTC-BB:CSLLY

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

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星期四, 五月 2, 2024
Outcomes research, RWE, Real, WHO, Influenza, World Health Organization, Influenza vaccine, ASX, CSL, Season, 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.

Key Points: 
  • 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.
  • "With data collected over three consecutive seasons, our study suggests higher vaccine effectiveness of cell-based quadrivalent influenza vaccines compared with standard egg-based influenza vaccines."
  • These data build on the growing evidence of real-world data that shows the benefits of our cell-based influenza vaccine," said Gregg Sylvester, Chief Health Officer and Head of Medical Affairs, CSL Seqirus.
  • "At CSL Seqirus, we're continually driving vaccine technology forward, in order to improve effectiveness and help keep communities healthy."

CSL Vifor and Travere Therapeutics Announce European Commission approves FILSPARI® (sparsentan) for the treatment of IgA Nephropathy

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星期三, 四月 24, 2024
Nephrology, Kidney disease, PROTECT, Proteinuria, European Commission, Kidney failure, Professor, CHMP, Irbesartan, European, EGFR, Senior, Patient, Kidney, CSL Vifor, CSL, Medicine, Committee, Civil service commission, RAAS, Teaching hospital, Clinical trial, Therapy, CMA, SAN, Pharmaceutical industry

ST. GALLEN, Switzerland and SAN DIEGO, April 24, 2024 /PRNewswire/ -- CSL Vifor and Travere Therapeutics, Inc., (NASDAQ: TVTX) today announced that the European Commission has granted conditional marketing authorization (CMA) for FILSPARI (sparsentan) for the treatment of adults with primary IgAN with a urine protein excretion ≥1.0 g/day (or urine protein-to-creatinine ratio ≥0.75 g/g). The CMA is granted for all member states of the European Union, as well as in Iceland, Liechtenstein and Norway.

Key Points: 
  • The CMA is granted for all member states of the European Union, as well as in Iceland, Liechtenstein and Norway.
  • Nephrology and Clinical Immunology at the University Hospital, RWTH Aachen, Germany, and steering committee member for the PROTECT clinical trial.
  • "The approval of this innovative treatment is based on data from the only head-to-head phase-III clinical trial in IgAN.
  • CSL Vifor expects to launch FILSPARI in the first European markets in the second half of 2024.

Ferinject® approved by Health Canada for the treatment of iron deficiency anemia in adult and pediatric patients and iron deficiency in adult patients with heart failure

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星期二, 三月 19, 2024
CSL Vifor, University, Research, Exercise, Classification, Health professional, Risk, Patient, Public, Palpitations, Health care, NYHA, News, Periodic breathing, Cardiovascular Research, Quality of life, Health Canada, Woman, Heart failure, Anemia, Fatigue, Hospital, Dietary supplement

Research shows that rates of iron deficiency are even higher than previously reported in Canada, with the condition particularly prevalent in women of reproductive age3 and children4.

Key Points: 
  • Research shows that rates of iron deficiency are even higher than previously reported in Canada, with the condition particularly prevalent in women of reproductive age3 and children4.
  • "The news of a new treatment option tested in clinical trials is welcomed, given that oral irons may not be able to adequately deliver the desired outcomes for Canadian patients with heart failure impacted by iron deficiency."
  • Iron deficiency affects one in every two hospitalized patients with heart failure5.
  • * The New York Heart Association Functional Classification is used by Healthcare Professionals to classify patients' heart failure based on the severity of their symptoms.

CSL Seqirus is Fully Prepared to Implement the FDA's Vaccines and Related Biological Products Advisory Committee Trivalent Influenza Vaccines Strain Selection for the 2024/25 U.S. Season

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星期三, 三月 6, 2024
FDA, Food, CSL, Influenza, Vaccine, Season, COVID-19, VRBPAC, WHO, Epidemiology, Environment, Public

CSL Seqirus worked closely with the FDA during 2023 to align on a path forward and is fully prepared to transition its complete portfolio of seasonal influenza vaccines in the U.S. market from quadrivalent to trivalent formulations for the 2024/25 influenza season.

Key Points: 
  • CSL Seqirus worked closely with the FDA during 2023 to align on a path forward and is fully prepared to transition its complete portfolio of seasonal influenza vaccines in the U.S. market from quadrivalent to trivalent formulations for the 2024/25 influenza season.
  • CSL Seqirus completed its transition plan for the 2024/2025 season by December 2023 and regulatory and manufacturing teams are on track to convert the full U.S. portfolio.
  • As a result of this effort, CSL Seqirus received FDA approval on March 4, 2024 for all of its U.S. trivalent influenza vaccines.
  • "This strain consistency across hemispheres will support both speed and efficiency, as CSL Seqirus has experience manufacturing these recommended strains," said Dave Ross, Vice President, North America Commercial Operations, CSL Seqirus.

Half year reported NPATA US$2 billion¹,² Up 13% at constant currency³

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星期二, 二月 13, 2024
Acquisition, Warfarin, CSL Behring, Depreciation, Research, Ministry, Messenger, CIDP, Marketing, CSL, Growth, Plasmapheresis, Primary immunodeficiency, Von Willebrand disease, Antibody, S&M, Immunodeficiency, ASX, Income tax, Haemophilia, HAE, Ministry of Health, CSL Vifor, Hereditary angioedema, Plasma, COVID, Patient, Webcast, Phase, Diagnosis, G&A, CC3, Pressure, CSL Limited, Vaccine

MELBOURNE, 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.

Key Points: 
  • Underlying profit (NPATA) was $2.02 billion1,2, up 13% on a constant currency basis to $2.06 billion1,2,3.
  • 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.
  • HIZENTRA® (Immune Globulin Subcutaneous (Human), 20% Liquid) sales were up 18%3 driven by  patient diagnosis rates.
  • However, due to the seasonality of this business we anticipate it to post a loss in the second half of the fiscal year.

Half year reported NPATA US$2 billion¹,² Up 13% at constant currency³

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星期二, 二月 13, 2024
Acquisition, Warfarin, CSL Behring, Depreciation, Research, Ministry, Messenger, CIDP, Marketing, CSL, Growth, Plasmapheresis, Primary immunodeficiency, Von Willebrand disease, Antibody, S&M, Immunodeficiency, ASX, Income tax, Haemophilia, HAE, Ministry of Health, CSL Vifor, Hereditary angioedema, Plasma, COVID, Patient, Webcast, Phase, Diagnosis, G&A, CC3, Pressure, CSL Limited, Vaccine

MELBOURNE, 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.

Key Points: 
  • Underlying profit (NPATA) was $2.02 billion1,2, up 13% on a constant currency basis to $2.06 billion1,2,3.
  • 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.
  • HIZENTRA® (Immune Globulin Subcutaneous (Human), 20% Liquid) sales were up 18%3 driven by  patient diagnosis rates.
  • However, due to the seasonality of this business we anticipate it to post a loss in the second half of the fiscal year.

CSL Announces Top-line Results from the Phase 3 AEGIS-II Trial Evaluating the Efficacy and Safety of CSL112 (apolipoprotein A-I [human])

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星期日, 二月 11, 2024
Caregiver, AEGIS, AMI, Apolipoprotein, CSL, MACE, Risk, Safety, ASX, History, American College, Patient, Harvard Medical School

The study did not meet its primary efficacy endpoint of MACE reduction at 90 days.

Key Points: 
  • The study did not meet its primary efficacy endpoint of MACE reduction at 90 days.
  • As a result, there are no plans for a near-term regulatory filing.
  • There were no major safety or tolerability concerns with CSL112.
  • "We will continue to analyze the findings and share the full results in the coming months."

New COVID-19 sa-mRNA Results from CSL and Arcturus Therapeutics Demonstrate Longer Duration of Immunity Compared to Conventional COVID-19 mRNA Vaccine Booster

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星期一, 二月 5, 2024
Pfizer–BioNTech COVID-19 vaccine, COVID-19, SARS-CoV-2, SAN, Senior, RNA, Arcturus, ARCT, GMT, Messenger, CSL, Therapy, ASX, Arcturus Therapeutics, Vaccine

KING OF PRUSSIA, Pa. and SAN DIEGO, Feb. 5, 2024 /PRNewswire/ -- 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).

Key Points: 
  • 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.
  • GMTs against Wuhan-Hu-1 remained numerically higher 180 days after ARCT-154 than those observed 28 days after the Comirnaty® booster.

Harris Poll Survey Finds People Receiving Treatment for CIDP Are Interested in Exploring More Convenient Treatment Options

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星期二, 一月 16, 2024
CIDP, Senior, Patient, Immunoglobulin therapy, Thought, CSL Behring, Spinal cord, Neurology, Associate, MD, University, Liquid, Skin, Sympathetic nervous system, Travel, Therapy, CSL, Brain, Physician, Nursing

KING OF PRUSSIA, Pa., Jan. 16, 2024 /PRNewswire/ -- CSL Behring, a business unit of global biotechnology leader CSL, today announced survey results showing that the majority of surveyed people living with chronic inflammatory demyelinating polyneuropathy (CIDP) agree they are interested in exploring more convenient treatment options (n=98, 82%) and that administering treatment at home is extremely/very important to them (n=100, 72%). However, less than half of people surveyed said they discuss potential new treatment options or switching treatments with a physician (n=100, 47% and 43% respectively). The CSL Behring-sponsored Harris Poll survey included 100 people living with CIDP, 98 of whom were currently on treatment for their CIDP, and 100 neurologists/neuromuscular specialists who regularly see at least one patient with CIDP.

Key Points: 
  • However, less than half of people surveyed said they discuss potential new treatment options or switching treatments with a physician (n=100, 47% and 43% respectively).
  • The CSL Behring-sponsored Harris Poll survey included 100 people living with CIDP, 98 of whom were currently on treatment for their CIDP, and 100 neurologists/neuromuscular specialists who regularly see at least one patient with CIDP.
  • Additionally, less than half of patients surveyed said they are very/somewhat knowledgeable about how different CIDP treatment options work (40%) or about how different CIDP treatment options are administered (45%).
  • "We are proud to be at the forefront of delivering both effective and convenient treatment options like Hizentra, which may allow those living with CIDP more flexibility by allowing them to self-administer their treatment at home.

CSL Behring Announces Availability of Hizentra® (Immune Globulin Subcutaneous [Human] 20% Liquid) 10g Prefilled Syringe

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星期三, 一月 3, 2024
PI, Travel, Immunoglobulin therapy, Learning, Physician, Disease, CIDP, Primary immunodeficiency, Therapy, CSL, The Harris Poll, CSL Behring, Patient, Skin, Senior, Vaccine

KING OF PRUSSIA, Pa., Jan. 3, 2024 /PRNewswire/ -- CSL Behring, a business unit of global biotechnology leader CSL, today announced the availability of a 10g prefilled syringe for Hizentra® (Immune Globulin Subcutaneous [Human] 20% Liquid). The Hizentra prefilled syringes provide people living with Primary Immunodeficiency (PI) and Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) the ability to elevate their treatment experience by eliminating the need to draw medication from vials. CSL Behring now has a wide range of prefilled syringe sizes to help meet the individual needs of people living with PI or CIDP including a 1g, 2g, 5g and 10g.

Key Points: 
  • CSL Behring now has a wide range of prefilled syringe sizes to help meet the individual needs of people living with PI or CIDP including a 1g, 2g, 5g and 10g.
  • Hizentra offers the convenience of at-home infusions under the skin for individuals managing PI or CIDP.
  • "The availability of the 10g prefilled syringe is CSL Behring's latest development in helping the rare disease community effectively manage PI and CIDP, as some patients may require treatment at a higher volume," said Bob Lojewski, Senior Vice President and General Manager, North America, CSL Behring.
  • The availability of a 10g prefilled syringe comes at a time when people living with PI and CIDP seek more convenient treatment options.