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Biosimilar SB12 Matches Eculizumab in PNH Treatment Across Diverse Patient Groups
03 Jul 2025 13:51 GMT
… and reference eculizumab limits its potential to significantly improve treatment accessibility in … global phase III randomized controlled trial. EJHaem. 2025;6(2):e70020 … hemoglobinuria
Jeremias S. FDA approves Epysqli as second Soliris biosimilar. The Center …
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Novartis' Cosentyx Fails Late-Stage Giant Cell Arteritis Trial
03 Jul 2025 13:15 GMT
… the competitive landscape for GCA treatments is evolving. Just in … U.S. Food and Drug Administration (FDA) and the European Commission … from anti-C5 therapies (eculizumab or ravulizumab).
The company … . After 24 weeks of treatment with Fabhalta, the Hb …
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New Wave in gMG Care: Cutting‑Edge Biologics Transform Treatment Landscape | Competitive Intelligence
19 Jun 2025 18:42 GMT
… 60.
Historically, treatment strategies centered on corticosteroids … gMG
Complement Inhibitors
- Eculizumab (Soliris) and Ravulizumab (Ultomiris … Global Access: High drug costs and logistical … Increased collaboration between biotech firms and academic …
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Samsung Bioepis Presents Long-Term Safety Data Of EPYSQLI (Eculizumab) In PNH At The European Hematology Association (EHA) Congress 2025
13 Jun 2025 15:04 GMT
… the U.S. Food and Drug Administration (FDA) and Korea’s Ministry … adverse reaction observed with eculizumab treatment in clinical trials was headache, (occurred mostly … .
1 Soliris is a trademark of Alexion Pharmaceuticals
2 European Medicines Agency. Epysqli …
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Iptacopan (Fabhalta) Hits Primary Endpoint in Phase 3 APPULSE-PNH Trial
12 Jun 2025 16:50 GMT
… needs not addressed by eculizumab or ravulizumab,” said Austin … those enrolled in previous trials, while offering an … history of cancer, unstable medical conditions including myocardial ischemia … Arm, Open Label Trial with Iptacopan Treatment for 24 Weeks, …
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Neuroinflammatory Impact of a CFI Variant
05 Jul 2025 14:58 GMT
Photo Credit: iStock.com/Pitju
A rare CFI variant linked to severe neuroinflammation was found to be highly enriched in the Old Order Amish population.
A study published in June 2025 issue of Journal of Allergy and clinical Immunology highlighted …
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Atypical Hemolytic Uremic Syndrome (aHUS): Breaking the Boundaries of Traditional Treatment | Competitive Intelligence
09 Jun 2025 13:37 GMT
… of complement inhibitors such as Soliris (eculizumab) and Ultomiris (ravulizumab) has … renal replacement therapies, and lifelong medication usage make it a resource … affordable treatment that fits seamlessly into patients’ lives.
Oral drugs like …
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Investigating Treatment Differences of Off-Label and Marketed Therapies for NMOSD: Sumaira Ahmed
06 Jun 2025 01:01 GMT
… such as satralizumab (Enspryng; Genentech), eculizumab (Soliris; Alexion), ravulizumab (Ultomiris; Alexion), … Amgen), may ultimately help inform treatment strategies for patients with NMOSD … she noted that the upcoming trial will compare efficacy of both …
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FDA Grants Fast Track Designation to Teva Celiac Disease Candidate
30 May 2025 18:54 GMT
… in a Phase IIa trial in order to … providing promising, innovative treatment options for patients with … eculizumab (brand name Soliris) (2). Eculizumab-aagh was approved by FDA … previously unmet medical needs (1).
References
1. Teva Pharmaceutical Industries. …
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Alexion awarded injunction against Amgen in SOLIRIS patent action; Court considers anticipation by incorporation by reference
27 May 2025 22:20 GMT
… selling its proposed biosimilar eculizumab product, BEKEMV, in … ,810).
In Alexion Pharmaceuticals, Inc v Amgen Canada … against Alexion’s eculizumab product SOLIRIS.
Eculizumab is a recombinant … SOLIRIS is the only medicine approved in Canada for the treatment …