| 2025-05-23 04:00:00 |
England’s Nice Recommends Filspari® (sparsentan) As A Treatment Option For Iga Nephropathy
First non-immunosuppressive dual-action therapy recommended by nice for eligible patients with iga nephropathy, a leading cause of kidney failure 1-3 nice’s recommendation is based on clinically meaningful results from the phase-iii protect trial 4 st. gallen, switzerland , may 23, 2025 /prnewswire/ -- csl vifor is pleased to announce that the national institute for health and care excellence (nice) has published final draft guidance recommending that sparsentan can be used in the nhs in england as an option to treat primary iga nephropathy in adults with a urine protein excretion of 1.0 g/day or more, or a urine protein-to-creatinine ratio of 0.75 g/g or more.3 nice has provided guidance to ensure that only patients responding to treatment continue.3 the decision follows authorisation from the uk’s medicines and healthcare products regulatory agency (mhra) in april 2025.5 what this means in practice is that there is enough evidence to show that sparsentan provides benefits and value for money, so it can be used routinely if it is considered the most suitable treatment option in this population.3 sparsentan must be funded in england within 90 days of final publication of this guidance3 which is expected to be 27 june 2025. |
| 2025-02-20 09:13:00 |
Csl Receives Approval In Japan For Andembry® (garadacimab) Subcutaneous (s.c.) Injection 200mg Pens, A Novel Human Anti-activated Factor Xii Monoclonal Antibody For The Prevention Of Acute Attacks Of Hereditary Angioedema (hae)
Andembry® is a first-in-class monoclonal antibody treatment that inhibits activated factor xii (fxiia), the initiating factor in the hae pathway, and offers the first pre-filled pen presentation enabling once-monthly subcutaneous administration the approval is based on the results of the international pivotal phase 3 vanguard trial, which included hae patients from japan csl is dedicated to improving the lives of those with hae – a community that we have proudly supported for more than 40 years tokyo , feb. 20, 2025 /prnewswire/ -- csl behring k.k. (headquarters: minato-ku, tokyo; president and representative director: izumi yoshida) today announced that it has received manufacturing and marketing approval from japan’s ministry of health, labour and welfare (mhlw) for andembry® (garadacimab) subcutaneous (s.c. |
| 2025-02-14 08:30:00 |
European Commission Approves Csl And Arcturus Therapeutics’ Kostaive®, The First Self-amplifying Mrna Covid-19 Vaccine
- kostaive represents a significant advancement in vaccine technology, demonstrating superior immunogenicity and antibody persistence for up to 12 months post-vaccination compared to conventional mrna covid-19 vaccines in clinical trials waltham, mass. and san diego , feb. 14, 2025 /prnewswire/ -- global biotechnology leader csl (asx: csl; usotc: cslly) and sa-mrna pioneer arcturus therapeutics (nasdaq: arct) today announced that the european commission has granted marketing authorization for kostaive ® (arct-154), a self-amplifying mrna covid-19 vaccine, for individuals 18 years and older. |
| 2025-02-14 08:00:00 |
European Commission Approves Csl And Arcturus Therapeutics’ Kostaive®, The First Self-amplifying Mrna Covid-19 Vaccine
Waltham, mass. & san diego--(business wire)---- $arct #clinicaltrial--global biotechnology leader csl (asx: csl; usotc: cslly) and sa-mrna pioneer arcturus therapeutics (nasdaq: arct) today announced that the european commission has granted marketing authorization for kostaive® (arct-154), a self-amplifying mrna covid-19 vaccine, for individuals 18 years and older. kostaive is the first sa-mrna covid-19 vaccine to receive approval from the european commission (ec). kostaive is currently marketed in japan against covid-. |
| 2025-02-13 07:00:00 |
European Commission Approves Csl’s Andembry® (garadacimab) For The Prevention Of Recurrent Attacks Of Hereditary Angioedema (hae)
- andembry®, the first and only once-monthly treatment targeting factor xiia to prevent attacks in hae patients, inhibits plasma protein factor xiia, which initiates the cascade of events leading to angioedema at various sites of the body- andembry reinforces csl’s decades-long commitment to delivering innovative treatment modalities to the hae community and comes with a convenient patient-centric pre-filled pen (auto-injector) enabling subcutaneous self-injection- supported by the phase 3 vanguard trial, this marks the third regulatory approval for andembry, which was also recently approved by australia’s therapeutic goods administration (tga) and the uk medicines and healthcare products regulatory agency (mhra) in january marburg, germany, feb. 13, 2025 /prnewswire/ -- global biotechnology leader csl (asx:csl; usotc:cslly) today announced that the european commission (ec) has approved andembry® (garadacimab), the first and only once-monthly treatment targeting factor xiia to prevent attacks of hereditary angioedema (hae) in adult and adolescent patients aged 12 years and older. andembry inhibits plasma protein factor xiia, which initiates the cascade of events leading to angioedema at various sites of the body. |
| 2025-02-07 09:12:00 |
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| 2024-12-13 10:38:00 |
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| 2024-10-18 08:30:00 |
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| 2024-10-16 09:00:00 |
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| 2024-10-04 12:30:00 |
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| 2024-10-01 11:00:00 |
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| 2024-09-30 08:00:00 |
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| 2024-09-25 16:30:00 |
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| 2024-09-24 03:30:00 |
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| 2024-09-17 11:30:00 |
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