Pemphigus vulgaris

Groundbreaking Study Demonstrates 20-Year Remission in Pemphigus Vulgaris Patients Using IVIg Therapy

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星期三, 一月 31, 2024

Researchers from Tufts University School of Medicine (Boston, MA) and Sorbonne Université (Paris, France) have demonstrated a remarkable 20-year clinical and serological remission in patients using a defined protocol of intravenous immunoglobulin (IVIg) therapy.

Key Points: 
  • Researchers from Tufts University School of Medicine (Boston, MA) and Sorbonne Université (Paris, France) have demonstrated a remarkable 20-year clinical and serological remission in patients using a defined protocol of intravenous immunoglobulin (IVIg) therapy.
  • Twenty-one patients with confirmed PV received IVIg therapy according to a specific protocol.
  • This long-term remission suggests that IVIg may help restore immune balance and tolerance in PV patients.
  • The pioneering research, offering sustained remission for pemphigus vulgaris patients, highlights the considerable potential of IVIg therapy.

Human medicines European public assessment report (EPAR): Rixathon, rituximab, Date of authorisation: 15/06/2017, Revision: 13, Status: Authorised

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星期四, 一月 4, 2024

Human medicines European public assessment report (EPAR): Rixathon, rituximab, Date of authorisation: 15/06/2017, Revision: 13, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Rixathon, rituximab, Date of authorisation: 15/06/2017, Revision: 13, Status: Authorised

Human medicines European public assessment report (EPAR): Blitzima, rituximab, Date of authorisation: 13/07/2017, Revision: 20, Status: Authorised

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星期二, 一月 2, 2024

Human medicines European public assessment report (EPAR): Blitzima, rituximab, Date of authorisation: 13/07/2017, Revision: 20, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Blitzima, rituximab, Date of authorisation: 13/07/2017, Revision: 20, Status: Authorised

Human medicines European public assessment report (EPAR): Ruxience, rituximab, Date of authorisation: 01/04/2020, Revision: 12, Status: Authorised

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星期二, 一月 2, 2024

Human medicines European public assessment report (EPAR): Ruxience, rituximab, Date of authorisation: 01/04/2020, Revision: 12, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Ruxience, rituximab, Date of authorisation: 01/04/2020, Revision: 12, Status: Authorised

Human medicines European public assessment report (EPAR): Riximyo, rituximab, Date of authorisation: 15/06/2017, Revision: 15, Status: Authorised

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星期二, 一月 2, 2024

Human medicines European public assessment report (EPAR): Riximyo, rituximab, Date of authorisation: 15/06/2017, Revision: 15, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Riximyo, rituximab, Date of authorisation: 15/06/2017, Revision: 15, Status: Authorised

argenx Reports Topline Results from ADDRESS Study of Efgartigimod SC in Pemphigus

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星期三, 十二月 20, 2023

argenx will not pursue additional development in pemphigus and plans to prioritize clinical development of efgartigimod in its ongoing severe autoimmune indications.

Key Points: 
  • argenx will not pursue additional development in pemphigus and plans to prioritize clinical development of efgartigimod in its ongoing severe autoimmune indications.
  • “We are disappointed by today’s results, particularly for pemphigus patients who have seen little innovation in this treatment space,” said Luc Truyen, M.D., Ph.D., Chief Medical Officer at argenx.
  • “We are grateful to the pemphigus community and all involved in the ADDRESS study, including patients, healthcare professionals, and our argenx teams,” continued Dr. Truyen.
  • Consistent pharmacodynamic (PD) effect of efgartigimod SC: Treatment with efgartigimod SC led to total immunoglobulin G (IgG) and desmoglein autoantibody (DSG-1 and DSG-3) reductions up to 75%.

Baudax Bio Acquires TeraImmune, Inc.

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星期五, 六月 30, 2023

MALVERN, Pa., June 30, 2023 (GLOBE NEWSWIRE) --  Baudax Bio, Inc. (Nasdaq:BXRX) (“Baudax Bio” or the “Company”), a pharmaceutical company focused on innovative products for acute care and related settings, today announced the acquisition of TeraImmune, a privately held a biotechnology company focused on discovery and development of novel Treg-based cell therapies for autoimmune diseases.

Key Points: 
  • “This combination blends the world class scientific expertise of the TeraImmune team with the Baudax team’s proven ability to execute clinical development programs, which we believe is a win for the shareholders of both companies,” said Ms. Henwood.
  • “This merger adds TeraImmune’s TI-168 asset to the Baudax portfolio—a promising next-generation, autologous FVIII TCR-Treg cell therapy candidate to eliminate clotting factor VIII (FVIII) inhibitors in Hemophilia A patients.
  • “We are looking forward to working with Gerri Henwood and the excellent clinical development team at Baudax to advance this asset to its full potential,” said Jihoon (Jay) Park, PhD, Co-Founder of TeraImmune.
  • In conjunction with the transaction, Yong Chan Kim, Ph D, former Chief Executive Officer of TeraImmune, will be appointed to the Board of Directors of Baudax.

Topas Therapeutics Initiates Phase 2a Clinical Trial for TPM502 in Celiac Disease; Appoints Chief Business Officer and Chief Operating Officer

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星期四, 五月 25, 2023

The company has received approval to initiate TPM502’s clinical development in a Phase 2a study based on TPM502 preclinical data and clinical results from the Phase 1 study assessing Topas’ TPC TPM203 in patients with pemphigus vulgaris.

Key Points: 
  • The company has received approval to initiate TPM502’s clinical development in a Phase 2a study based on TPM502 preclinical data and clinical results from the Phase 1 study assessing Topas’ TPC TPM203 in patients with pemphigus vulgaris.
  • “The Phase 2a study will determine the capacity of TPM502 to promote immune tolerization in celiac disease patients and will confirm the safety profile of TPCs.
  • It will also further establish the potential of the Topas platform to generate novel therapeutics for the treatment of T-cell-mediated diseases,” commented Cristina de Min, MD, Chief Medical Officer of Topas Therapeutics.
  • Mireia Gómez-Angelats, PhD, has joined as Chief Business Officer and Christian Schröter, PhD, as Chief Operating Officer, adding significant international pharmaceutical experience to Topas’ leadership as the company moves to mid-stage clinical development.

Cabaletta Bio Presents New Interim Data from the DesCAARTes™ Phase 1 Trial at the 31st EADV Congress

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星期六, 九月 10, 2022

The data demonstrate:

Key Points: 
  • The data demonstrate:
    Doses up to 7.5 billion DSG3-CAART cells (cohort A5) were generally well tolerated, with no DLTs, and one grade 1 CRS.
  • The trial is currently being conducted across multiple clinical sites throughout the United States and is enrolling patients in the combination sub-study.
  • Cabalettas DesCAARTes Phase 1 trial is an open-label, dose escalation, multi-center study of DSG3-CAART in adults with mucosal-dominant pemphigus vulgaris (mPV).
  • Cabaletta Bios headquarters are located in Philadelphia, PA. For more information, visit www.cabalettabio.com and follow us on LinkedIn and Twitter.