Microscopic polyangiitis

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

Retrieved on: 
Thursday, January 4, 2024
Marketing, BAL, PV, INN, Risk, MPA, Shivering, DLBCL, CD20, BLL, PML, Pemphigus vulgaris, Cancer, Inflammation, Infection, Anatomy, IIA, Skin, Chills, Fever, ATC, Joint, Bone marrow, GPA, Disease, Nose, Ageing, Allergy, Glucocorticoid, CLL, NHL, Safety, Rheumatoid arthritis, Patient, Medical Subject Headings, Cyclophosphamide, Immune system, Granuloma, Antibody, Vincristine, International, Arthritis, Language, Mouth, Follicular lymphoma, Microscopic polyangiitis, Select, Overview, B cell, Methotrexate, Prednisolone, TNF, CHOP, Blood, Vasculitis, Lymphocytosis, European Medicines Agency, Doxorubicin, Chronic lymphocytic leukemia, DMARD, Medical device

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

Retrieved on: 
Tuesday, January 2, 2024
Marketing, INN, Risk, MPA, Shivering, CD20, PML, ACR20, Pemphigus vulgaris, Cancer, Inflammation, Death, Infection, Anatomy, IIA, Skin, Chills, Fever, ATC, Bone marrow, GPA, Disease, Allergy, Hepatitis B virus, CLL, NHL, Safety, Arthritis, Patient, Medical Subject Headings, Cyclophosphamide, Immune system, Antibody, Vincristine, International, Language, Mouth, Follicular lymphoma, Microscopic polyangiitis, Select, Encephalitis, Medicine, B cell, Prednisolone, Autoimmune disease, CHOP, Blood, Rheumatoid arthritis, Vasculitis, European Medicines Agency, Doxorubicin, Cell, Chronic lymphocytic leukemia, Resuscitation, Medical device

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): Truxima, rituximab, Date of authorisation: 17/02/2017, Revision: 21, Status: Authorised

Retrieved on: 
Tuesday, January 2, 2024
Marketing, INN, Risk, MPA, Shivering, CD20, PML, ACR20, Pemphigus vulgaris, Cancer, Inflammation, Death, Infection, Anatomy, IIA, Skin, Chills, Fever, ATC, Joint, Bone marrow, GPA, Disease, Pemphigus, Allergy, B cell, Hepatitis B virus, Glucocorticoid, NHL, CLL, Safety, Rheumatoid arthritis, Arthritis, Patient, Medical Subject Headings, Cyclophosphamide, Immune system, Granuloma, Antibody, Vincristine, International, Language, Blood, Mouth, Follicular lymphoma, Microscopic polyangiitis, Select, Methotrexate, Prednisolone, Autoimmune disease, TNF, CHOP, Vasculitis, European Medicines Agency, Doxorubicin, Cell, Chronic lymphocytic leukemia, Resuscitation, DMARD, Pharmaceutical industry

Human medicines European public assessment report (EPAR): Truxima, rituximab, Date of authorisation: 17/02/2017, Revision: 21, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Truxima, rituximab, Date of authorisation: 17/02/2017, Revision: 21, Status: Authorised

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

Retrieved on: 
Tuesday, January 2, 2024
Marketing, PV, INN, Risk, MPA, Shivering, CD20, PML, Pemphigus vulgaris, Inflammation, Infection, Anatomy, Lymphoma, IIA, Skin, Chills, Fever, ATC, Joint, Bone marrow, GPA, Disease, Nose, Allergy, Glucocorticoid, NHL, CLL, Safety, Rheumatoid arthritis, Patient, Medical Subject Headings, Cyclophosphamide, Immune system, Granuloma, Antibody, Vincristine, International, Arthritis, Language, Mouth, Follicular lymphoma, Microscopic polyangiitis, Select, B cell, Methotrexate, Prednisolone, TNF, CHOP, Blood, Vasculitis, European Medicines Agency, Doxorubicin, Chronic lymphocytic leukemia, DMARD, Medical device

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

Retrieved on: 
Tuesday, January 2, 2024
Marketing, BAL, PV, INN, Risk, MPA, Shivering, DLBCL, Pemphigus, CD20, BLL, PML, Pemphigus vulgaris, Cancer, Inflammation, Infection, Anatomy, IIA, Skin, Chills, Fever, ATC, Bone marrow, GPA, Nose, Ageing, Allergy, Glucocorticoid, CLL, NHL, Safety, Rheumatoid arthritis, Patient, Medical Subject Headings, Cyclophosphamide, Immune system, Granuloma, Antibody, Vincristine, International, Arthritis, Language, Mouth, Follicular lymphoma, Microscopic polyangiitis, Select, Methotrexate, Prednisolone, TNF, CHOP, Blood, Vasculitis, Lymphocytosis, European Medicines Agency, Doxorubicin, Chronic lymphocytic leukemia, DMARD, Medical device

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

Dr. Reddy’s Proposed Rituximab Biosimilar Application Accepted for Review by USFDA, EMA and MHRA

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Wednesday, July 12, 2023
FDA, Pharmaceutical, Health, Clinical Trials, China Biologic Products, BSE, Rituximab, EU, Fresenius (company), Vasculitis, File, Chronic lymphocytic leukemia, Marketing, CD20, Health care, European Medicines Agency, USFDA, Pharmacokinetics, RDY, Rheumatoid arthritis, Microscopic polyangiitis, EMA, NSE, B-cell lymphoma, Patient, Granuloma, Medicines and Healthcare products Regulatory Agency, Biosimilar, United, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Safety, BLA, NYSE, Food, MHRA, Generic drug

Reddy’s”), a global pharmaceutical company, announced that its Biologics License Application (BLA) for its proposed biosimilar rituximab candidate DRL_RI has been accepted for a substantive review by the U.S. Food and Drug Administration (USFDA).

Key Points: 
  • Reddy’s”), a global pharmaceutical company, announced that its Biologics License Application (BLA) for its proposed biosimilar rituximab candidate DRL_RI has been accepted for a substantive review by the U.S. Food and Drug Administration (USFDA).
  • This closely follows acceptance of its rituximab biosimilar dossier for review by two other regulatory agencies – the European Medicines Agency (EMA) and the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA).
  • DRL_RI is being developed as a biosimilar of Rituxan® / MabThera® (rituximab), a cluster of differentiation 20 (CD20) directed cytolytic antibody.
  • generic drugs for critical and chronic conditions, to commercialise its proposed biosimilar of rituximab in the United States.

Tavneos® (avacopan) included in updated EULAR recommendations for the management of AAV

Retrieved on: 
Tuesday, March 28, 2023
Rituximab, ST, Vasculitis, Annals of the Rheumatic Diseases, GPA, IB, Glucocorticoid, Cyclophosphamide, Glomerular filtration rate, CSL Vifor, European Congress of Radiology, AAV, Microscopic polyangiitis, Anti-neutrophil cytoplasmic antibody, ANCA, Patient, European, Diagnosis, MPA, EULAR, Pharmaceutical industry, Rheumatology

ST. GALLEN, Switzerland, March 28, 2023 /PRNewswire/ -- Vifor Fresenius Medical Care Renal Pharma (VFMCRP) is pleased to announce that Tavneos® has been included in the revised EULAR AAV management recommendations, as one of several important updates in the 2022 version. As part of a strategy to substantially reduce exposure to glucocorticoids, Tavneos® should be considered a therapy option in combination with rituximab or cyclophosphamide for induction of remission in patients with active granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA), two main forms of AAV.

Key Points: 
  • The updated recommendations propose Tavneos® as the strategy to substantially reduce the exposure to glucocorticoids (class IB recommendation).
  • Furthermore, this recommendation acknowledges Tavneos®' role in potentially improving kidney function as measured by glomerular filtration rate in patients with active glomerulonephritis and renal involvement.
  • "We are very pleased with the new AAV management recommendations and are grateful for this development for patients living with this systemic condition", said Fabio Dorigotti, Head Global Medical Affairs of CSL Vifor.
  • The EULAR recommendations for the management of AAV aim to provide practical, evidence-based recommendations for the diagnosis and treatment of AAV, thereby improving and harmonizing standards of diagnosis and treatment, and potentially improving quality of care.

Tavneos® (avacopan) included in updated EULAR recommendations for the management of AAV

Retrieved on: 
Tuesday, March 28, 2023
Rituximab, ST, Vasculitis, Annals of the Rheumatic Diseases, GPA, IB, Glucocorticoid, Cyclophosphamide, Glomerular filtration rate, CSL Vifor, European Congress of Radiology, AAV, Microscopic polyangiitis, Anti-neutrophil cytoplasmic antibody, ANCA, Patient, European, Diagnosis, MPA, EULAR, Pharmaceutical industry, Rheumatology

ST. GALLEN, Switzerland, March 28, 2023 /PRNewswire/ -- Vifor Fresenius Medical Care Renal Pharma (VFMCRP) is pleased to announce that Tavneos® has been included in the revised EULAR AAV management recommendations, as one of several important updates in the 2022 version. As part of a strategy to substantially reduce exposure to glucocorticoids, Tavneos® should be considered a therapy option in combination with rituximab or cyclophosphamide for induction of remission in patients with active granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA), two main forms of AAV.

Key Points: 
  • The updated recommendations propose Tavneos® as the strategy to substantially reduce the exposure to glucocorticoids (class IB recommendation).
  • Furthermore, this recommendation acknowledges Tavneos®' role in potentially improving kidney function as measured by glomerular filtration rate in patients with active glomerulonephritis and renal involvement.
  • "We are very pleased with the new AAV management recommendations and are grateful for this development for patients living with this systemic condition", said Fabio Dorigotti, Head Global Medical Affairs of CSL Vifor.
  • The EULAR recommendations for the management of AAV aim to provide practical, evidence-based recommendations for the diagnosis and treatment of AAV, thereby improving and harmonizing standards of diagnosis and treatment, and potentially improving quality of care.

Dr. Reddy’s successfully completes full set of clinical studies of its rituximab biosimilar for filing in the U.S., Europe

Retrieved on: 
Friday, January 20, 2023
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Rituximab, RDY, Marketing, CD20, Rheumatoid arthritis, Biosimilar, Lymphocytosis, Microscopic polyangiitis, Fresenius (company), NYSE, B-cell lymphoma, MAA, Granuloma, NSE, Patient, BLA, File, BSE, Vasculitis, Generic drug

Reddy’s”), a global pharmaceutical company, announced that it has successfully completed the full set of clinical studies of its proposed rituximab biosimilar candidate, DRL_RI, for filing in highly regulated markets such as the United States, Europe and other regions.

Key Points: 
  • Reddy’s”), a global pharmaceutical company, announced that it has successfully completed the full set of clinical studies of its proposed rituximab biosimilar candidate, DRL_RI, for filing in highly regulated markets such as the United States, Europe and other regions.
  • Dr. Reddy’s rituximab biosimilar has already been approved for marketing in India and over 25 emerging markets.
  • The company undertook further clinical development to meet regulatory requirements of highly regulated markets.
  • The successful completion and positive outcome of these clinical studies highlights our capability for global clinical development of biosimilar products for highly regulated and global markets.

Global ANCA Vasculitis Drug Pipeline Market Research Report 2022 Featuring GSK, AstraZeneca, Staidson Biopharmaceuticals, Bristol-Myers Squibb, InflaRx, Chia Tai Tianqing Pharmaceutical & Visterra - ResearchAndMarkets.com

Retrieved on: 
Thursday, August 25, 2022
Health, Pharmaceutical, AstraZeneca, Eosinophilic granulomatosis with polyangiitis, NDA, II, Technology, Benralizumab, Asthma, Survival, Awareness, Macrophage, Disease, Signal transduction, Basophil, Vasculitis, MedImmune, GlaxoSmithKline, ANCA, FDA, Therapy, Eosinophil, News, III, Clinical trial, Immunoglobulin G, Microscopic polyangiitis, Acquisition, Discovery, Patient, Pharmaceutical industry

The "Global ANCA Vasculitis - Pipeline Insight, 2022" drug pipelines has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Global ANCA Vasculitis - Pipeline Insight, 2022" drug pipelines has been added to ResearchAndMarkets.com's offering.
  • This "ANCA Vasculitis - Pipeline Insight, 2022" report provides comprehensive insights about 8+ companies and 8+ pipeline drugs in ANCA Vasculitis pipeline landscape.
  • A detailed picture of the ANCA Vasculitis pipeline landscape is provided which includes the disease overview and ANCA Vasculitis treatment guidelines.
  • The assessment part of the report embraces, in depth ANCA Vasculitis commercial assessment and clinical assessment of the pipeline products under development.