ACR20

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): Amsparity, adalimumab, Date of authorisation: 13/02/2020, Revision: 5, Status: Authorised

Retrieved on: 
Tuesday, January 2, 2024
Marketing, MRI, INN, Contraindication, AZA, Axial spondyloarthritis, Rash, Tissue, ACR20, Heart, Cancer, Inflammation, Red, Disease-modifying antirheumatic drug, Ankylosing spondylitis, Infection, Back pain, Anatomy, Ulcer, IIA, Skin, Hidradenitis suppurativa, Tuberculosis, Bone marrow, Adolescence, ATC, Joint, Crohn's disease, Hidradenitis, Pain, Psoriatic arthritis, Bleeding, Disease, Nose, Ageing, Nonsteroidal anti-inflammatory drug, Blood, Safety, Heart failure, CRP, Rheumatoid arthritis, Patient, Medical Subject Headings, Immune system, Ulcerative colitis, International, HS, Lupus, Arthritis, Language, Mouth, Laboratory, Scar, Select, Methotrexate, Azathioprine, TNF, Headache, Swelling, Stevens–Johnson syndrome, European Medicines Agency, Spine, Abscess, Child, Pharmaceutical industry

Human medicines European public assessment report (EPAR): Amsparity, adalimumab, Date of authorisation: 13/02/2020, Revision: 5, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Amsparity, adalimumab, Date of authorisation: 13/02/2020, Revision: 5, Status: Authorised

Aclaris Therapeutics Announces Top-line Results from 12-Week Phase 2b Trial of Oral Zunsemetinib (ATI-450) for Moderate to Severe Rheumatoid Arthritis and Provides Corporate Update

Retrieved on: 
Monday, November 13, 2023
Webcast, Pancreatic cancer, MK2, Safety, Therapy, Clinical trial, Patient, ACR20, Rheumatoid arthritis, ACRS, Pharmacokinetics, Ulcerative colitis, Atopic dermatitis, Topical medication, Toxic leukoencephalopathy, Osteoporosis, MTX, Pharmaceutical industry, Czech Republic

WAYNE, Pa., Nov. 13, 2023 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel drugs for immuno-inflammatory diseases, today announced top-line results from a Phase 2b study of zunsemetinib (ATI-450), an investigational oral MK2 inhibitor, in subjects with moderate to severe rheumatoid arthritis (RA; ATI-450-RA-202).

Key Points: 
  • The primary efficacy endpoint is the proportion of patients achieving an ACR20 response following 12 weeks of treatment.
  • Based on the overall program results, Aclaris will discontinue further development of the ATI-450 program, including halting enrollment of Aclaris’ ongoing Phase 2a trial of zunsemetinib in psoriatic arthritis.
  • “We are deeply disappointed with the results of this trial and for patients suffering from rheumatoid arthritis.
  • Aclaris is supporting Washington University in a first-in-human investigator-initiated Phase 1a trial of ATI-2231 in patients with advanced solid tumor malignancies.

Aclaris Therapeutics Completes Enrollment in Phase 2b Study of Oral Zunsemetinib (ATI-450) for Moderate to Severe Rheumatoid Arthritis (ATI-450-RA-202)

Retrieved on: 
Tuesday, June 13, 2023
RA, ACR20, Pharmacokinetics, Rheumatoid arthritis, ACRS, Patient, Therapy, MTX, Safety, Pharmaceutical industry

WAYNE, Pa., June 13, 2023 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel drug candidates for immuno-inflammatory diseases, today announced the completion of enrollment into ATI-450-RA-202, its Phase 2b trial of oral zunsemetinib in patients with moderate to severe rheumatoid arthritis (RA). Aclaris expects to announce top-line efficacy, safety and other preliminary data from this trial in the fourth quarter of this year.

Key Points: 
  • WAYNE, Pa., June 13, 2023 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel drug candidates for immuno-inflammatory diseases, today announced the completion of enrollment into ATI-450-RA-202, its Phase 2b trial of oral zunsemetinib in patients with moderate to severe rheumatoid arthritis (RA).
  • Aclaris expects to announce top-line efficacy, safety and other preliminary data from this trial in the fourth quarter of this year.
  • The primary efficacy endpoint is the proportion of patients achieving an ACR20 response following 12 weeks of treatment.
  • Secondary efficacy endpoints include ACR50 response, ACR70 response, DAS28-CRP and other pertinent RA measures.

EQS-News: Abivax reports 2022 financial results and operations update

Retrieved on: 
Wednesday, April 19, 2023
Operating cost, CD, US Foods, Marketing, United European Gastroenterology, G&A, Malignancy, Congress, COVID-19, Investment, Patient, Ageing, ITT, ARD, HCC, Rheumatoid arthritis, Maintenance, Sofinnova, Neurotransmission, Clinical and Translational Gastroenterology, Methotrexate, De novo, EMA, Cancer, CTG, EULAR, Mall of America, FDA, Natural killer T cell, Safety, European Medicines Agency, Volunteering, Inflammatory Bowel Diseases, PIP, UEG, Ulcerative colitis, Publication, Blood, MTX, Nivolumab, Partnership, RA, ACR20, IBD, Bank statement, ECCO, Bristol Myers Squibb, CCO, Fungal infection, ASCO, EUR, Scripps, Food, Pharmaceutical industry, Management, Abivax, Rheumatology, UC, Gastroenterology

The ABTECT program was initiated in the first half of 2022 and the first patient in the United States was enrolled on October 11, 2022.

Key Points: 
  • The ABTECT program was initiated in the first half of 2022 and the first patient in the United States was enrolled on October 11, 2022.
  • Abivax recently reported the results of its Phase 2b maintenance trial of obefazimod in UC after two years of continued once-daily treatment with 50mg obefazimod.
  • In March 2022, Abivax announced its Phase 2a maintenance trial results of obefazimod in RA.
  • In January 2022, Abivax presented the results of the dose escalation phase of its Phase 1/2 clinical trial in HCC at the ASCO GI Cancers Symposium.

Long-Term Psoriatic Arthritis Data for AbbVie's Skyrizi Likely to Impact Future IL-23 Preference, Spherix Global Insights Reports

Retrieved on: 
Wednesday, December 21, 2022
Patient, Gastroenterology, HCP, Dermatology, Nephrology, ACR20, Rheumatology, Novartis, JAK, Janssen, Neck, Dactylitis, News, Psoriatic arthritis, Keepsake, IL-23, AbbVie, TNF, PASI, Ophthalmology, Skin, Neurology, Pharmaceutical industry, Guselkumab, Risankizumab, Upadacitinib

EXTON, Pa., Dec. 21, 2022 /PRNewswire/ -- Spherix Global Insights, a leading provider of market research, business intelligence, and advisory services to the global life sciences industry, has been tracking the evolution of the US psoriatic arthritis (PsA) market for seven years, including the uptake and impact of various market entrants.

Key Points: 
  • RealTime Dynamix™ is an independent study service by Spherix Global Insights that provides strategic guidance through quarterly or semiannual reports.
  • Spherix Global Insights is a leading provider of market research, business intelligence and advisory services to the global life sciences industry.
  • A trusted advisor and industry thought leader, Spherix Global Insights provides specialized market expertise in six (6) focused therapeutic areas including: dermatology, gastroenterology, nephrology, neurology, rheumatology and ophthalmology.
  • To learn more about Spherix Global Insights, visit spherixglobalinsights.com or connect through LinkedIn and Twitter .

EQS-News: GSK, MorphoSys’ Licensing Partner, Provides Update on ContRAst Phase III Program for Otilimab in Moderate to Severe Rheumatoid Arthritis  

Retrieved on: 
Friday, October 28, 2022
Janus, U.S. Securities and Exchange Commission, American College, Clinical trial, LinkedIn, Rheumatoid arthritis, Contrast, NASDAQ, Safety, Cancer, IIL, ACR20, Disease-modifying antirheumatic drug, Janus kinase inhibitor, GSK, III, Communication, Program, Annual report, Patient, Judgement, Industry, RA, Risk, Twitter, Health, American College of Rheumatology, Population, FSE, Pharmaceutical industry, MorphoSys

MorphoSys AG (FSE: MOR; NASDAQ: MOR) announced today that its licensing partner, GSK plc (LSE/NYSE: GSK), provided an update on the ContRAst phase III program for otilimab as apotential treatment of moderate to severe rheumatoid arthritis (RA).

Key Points: 
  • MorphoSys AG (FSE: MOR; NASDAQ: MOR) announced today that its licensing partner, GSK plc (LSE/NYSE: GSK), provided an update on the ContRAst phase III program for otilimab as apotential treatment of moderate to severe rheumatoid arthritis (RA).
  • The ContRAst phase IIl program enrolled a broad range of difficult-to-treat patients who had an inadequate response to or could not tolerate available treatments.
  • GSK is planning to submit full results from the ContRAst phase III program for publication in 2023.
  • As a global commercial-stage biopharmaceutical company, we use groundbreaking science and technologies to discover, develop, and deliver innovative cancer medicines to patients.

First Patient Enrolled in Stage 2 of Pivotal Study of SetPoint Medical’s Pioneering Technology for the Treatment of Rheumatoid Arthritis

Retrieved on: 
Monday, October 10, 2022
Medical Devices, Health, Health Technology, Clinical Trials, General Health, Biotechnology, Risk, Rheumatoid arthritis, Arthritis, Neck, Patient, Inflammation, University, Stage 2, Disability, Disease-modifying antirheumatic drug, University of New Mexico Hospital, CEO, Pain, Key Stage 1, Safety, ACR20, RA, American College of Rheumatology, Pharmacotherapy, Inflammatory bowel disease, Albuquerque Air Route Traffic Control Center, FDA, Vagus nerve stimulation, American College, Inflection point, Data analysis, Vagus nerve, Pharmaceutical industry, Dentistry, Rheumatology

The RESET-RA study is evaluating SetPoint Medical's investigational platform technology for treatment of rheumatoid arthritis (RA) using vagus nerve stimulation to activate innate anti-inflammatory pathways.

Key Points: 
  • The RESET-RA study is evaluating SetPoint Medical's investigational platform technology for treatment of rheumatoid arthritis (RA) using vagus nerve stimulation to activate innate anti-inflammatory pathways.
  • The company recently announced FDA approval for continuation to Stage 2 of the study based on outcomes from an interim data analysis.
  • We enrolled multiple patients in Stage 1 of the study, and are looking forward to contributing more participants in the second stage of the study.
  • The RESET-RA study is the first-of-its-kind study to evaluate vagus nerve stimulation for the treatment of RA.

Eisai: Metoject Subcutaneous Injection Syringe (Methotrexate) Approved in Japan for Rheumatoid Arthritis

Retrieved on: 
Monday, September 26, 2022
Safety, Incidence, American College, Stomatitis, Psoriatic arthritis, Disulfiram-like drug, Rheumatoid arthritis, Medac, MTX, Gesellschaft mit beschränkter Haftung, Patient, Eisai, Pain, Gemeinschaft and Gesellschaft, Nausea, Marketing, American College of Rheumatology, ACR20, Pharmaceutical industry, Methotrexate, Health

Metoject will be the first self-administrable MTX subcutaneous injection formulation for rheumatoid arthritis in Japan.

Key Points: 
  • Metoject will be the first self-administrable MTX subcutaneous injection formulation for rheumatoid arthritis in Japan.
  • It is reported that there are approximately 700,000 - 800,000 rheumatoid arthritis patients in Japan.
  • Eisai and nippon medac will provide a self-administrable subcutaneous injection as a new treatment option for rheumatoid arthritis patients in Japan as soon as possible, and will make further contributions to address the diversified needs of, and increase the benefits provided to, rheumatoid arthritis patients.
  • *ACR20 is a criterion developed by the American College of Rheumatology that measures improvement in clinical symptoms of rheumatoid arthritis.