Methotrexate

Biogen Receives Positive CHMP Opinion for TOFIDENCE™ (tocilizumab), a Biosimilar Referencing ROACTEMRA®

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星期四, 四月 25, 2024
BIIB, Biogen, Adalimumab, Methotrexate, Etanercept, Safety, Pharmacokinetics, European Commission, CHMP, Condylar resorption, Tocilizumab, European, Patient, Rheumatoid arthritis, EMA, Infliximab, Committee, Civil service commission, COVID-19, European Medicines Agency, Vaccine

CHMP positive opinion is based on a robust analytical, non-clinical and clinical data package comparing TOFIDENCE™ to the reference product ROACTEMRA®

Key Points: 
  • CHMP positive opinion is based on a robust analytical, non-clinical and clinical data package comparing TOFIDENCE™ to the reference product ROACTEMRA®
    CAMBRIDGE, Mass., April 25, 2024 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion for TOFIDENCE™ (tocilizumab), a biosimilar monoclonal antibody referencing ROACTEMRA®1.
  • The CHMP’s positive opinion will now be referred to the European Commission (EC), which will decide whether to grant marketing authorization for TOFIDENCE.
  • “The positive CHMP recommendation for TOFIDENCE marks another positive step toward helping more people with inflammatory and immune-mediated conditions gain access to leading therapies,” said Ian Henshaw, Global Head of Biosimilars at Biogen.
  • Under the agreement, Biogen has exclusive regulatory, manufacturing, and commercial rights to TOFIDENCE in all countries excluding China (including Hong Kong, Macau and Taiwan).

Roivant and Kinevant Sciences Complete Enrollment in RESOLVE-Lung, a Phase 2 Study Evaluating Namilumab for Chronic Pulmonary Sarcoidosis

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星期四, 四月 25, 2024
Biotechnology, Pharmaceutical, Health, Clinical Trials, Pain, Sarcoidosis, Inflammation, Granuloma, Research, GM-CSF, Disease, Patient, Fatigue, Fibrosis, Lung, Namilumab, Clinical trial, Prednisone, Methotrexate, Pharmaceutical industry

Roivant (Nasdaq: ROIV) and Kinevant Sciences , a clinical-stage biopharmaceutical company developing new medicines for rare inflammatory and autoimmune diseases, today announced the successful completion of enrollment in its Phase 2 study evaluating namilumab for the treatment of chronic pulmonary sarcoidosis (RESOLVE-Lung).

Key Points: 
  • Roivant (Nasdaq: ROIV) and Kinevant Sciences , a clinical-stage biopharmaceutical company developing new medicines for rare inflammatory and autoimmune diseases, today announced the successful completion of enrollment in its Phase 2 study evaluating namilumab for the treatment of chronic pulmonary sarcoidosis (RESOLVE-Lung).
  • Potentially supportive of registration, RESOLVE-Lung is a randomized, double-blind, placebo-controlled Phase 2 study designed to enroll a minimum of 100 pulmonary sarcoidosis patients whose disease is not well-controlled despite currently available treatment options.
  • “Completing enrollment for this study is an important milestone in our journey to develop a new therapy for those living with pulmonary sarcoidosis.
  • Thus, namilumab has the potential to be the only well-tolerated and effective therapy for sarcoidosis, as well as the first therapy approved specifically for pulmonary sarcoidosis.

U.S. FDA Approves Subcutaneous Administration of Takeda’s ENTYVIO® (vedolizumab) for Maintenance Therapy in Moderately to Severely Active Crohn’s Disease

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星期五, 四月 19, 2024
Biotechnology, FDA, Health, Pharmaceutical, Clinical Trials, Ulcerative colitis, TNF, Azathioprine, CDAI, Safety, Education, Food, MD, Burnett School of Medicine, Week, Patient, Methotrexate, UC, Pharmaceutical industry

“Crohn’s disease is a complex and usually progressive disease for which an appropriate management plan is critical.

Key Points: 
  • “Crohn’s disease is a complex and usually progressive disease for which an appropriate management plan is critical.
  • “Our development of a subcutaneous option demonstrates Takeda’s commitment to meeting the very real needs of those living with gastrointestinal diseases.”
    *Please refer to “U.S.
  • FDA Approves Subcutaneous Administration of Takeda’s ENTYVIO® (vedolizumab) for Maintenance Therapy in Moderately to Severely Active Ulcerative Colitis”, dated September 27, 2023.
  • Takeda does not expect a material impact on the consolidated financial statements as a result of this approval.

China Medical System （867.HK）2023 Annual Results: Despite of the Temporary Financial Performance Pressure Fresh Catalysts Emerged from Successive Innovation Breakthroughs

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星期四, 三月 28, 2024
Sclerotherapy, RMB, Conditional sentence, NDA, IND, Creativity, Small RNA, Marketing, Gastroenterology, Central nervous system, FIC, City, BIC, CMS, NRDL, Injection, Dermatology, CDMO, Commercialization, Tablet, Pharmacy, Methotrexate, Hospital, Acquisition, Gonadotropin-releasing hormone, RCT, VBP, Rheumatoid arthritis, Growth, Varicose veins, Ecosystem, Blue, Government, Ophthalmology

SHENZHEN, CHINA, March 27, 2024 (GLOBE NEWSWIRE) -- On March 27, 2024, China Medical System (“CMS” or the “Company”) released its 2023 annual results.

Key Points: 
  • SHENZHEN, CHINA, March 27, 2024 (GLOBE NEWSWIRE) -- On March 27, 2024, China Medical System (“CMS” or the “Company”) released its 2023 annual results.
  • Based on above, CMS has successfully entered into its “New Period” of innovation and internationalization development.
  • 4 innovative drugs have started large-scale clinical application, unveiling CMS’s first year of commercialization era of innovative drugs.
  • Under its compliant and efficient commercialization system, the Company's innovative products and exclusive drugs will grow steadily.

Withdrawn application: Orencia, 19/02/2024

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星期三, 四月 3, 2024
CD86, Graft-versus-host disease, Gene, Methotrexate, Psoriasis, Letter, Cell, Bone marrow, Risk, Inflammation, Patient, Ageing, Psoriatic arthritis, HSCT, Allele, Joint, Protein, HLA, European Medicines Agency, Arthritis, Syringe, Rheumatism, Agency, Clinical trial, Skin, CD80, Cancer, Immune system, Blood, Calcineurin, Medicine, Vaccine

Withdrawn application: Orencia, 19/02/2024

Key Points: 


Withdrawn application: Orencia, 19/02/2024

Summary of opinion: Bimzelx, 21/03/2024 Positive

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星期三, 四月 3, 2024
Civil service commission, Psoriatic arthritis, Hidradenitis suppurativa, Methotrexate, Psoriasis, MRI, Magnetic resonance imaging, Inflammation, Committee, Nonsteroidal anti-inflammatory drug, Disease-modifying antirheumatic drug, HS, Medication package insert, C-reactive protein, Ankylosing spondylitis, European Commission, Marketing, CHMP, CRP, Axial spondyloarthritis

On 21 March 2024, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Bimzelx.

Key Points: 
  • On 21 March 2024, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Bimzelx.
  • The marketing authorisation holder for this medicinal product is UCB Pharma S.A.
  • The CHMP adopted a new indication for the treatment of hidradenitis suppurativa.
  • Ankylosing spondylitis (AS, radiographic axial spondyloarthritis)
    Bimzelx is indicated for the treatment of adults with active ankylosing spondylitis who have responded inadequately or are intolerant to conventional therapy.

Most Effective Atopic Dermatitis Treatments May Also Be Most Harmful

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星期三, 二月 21, 2024
Atopic dermatitis, AAAAI, MEDLINE, Research, Multimedia, Conjunctivitis, Meta-analysis, Ciclosporin, Physician, Quality of life, Asthma, Methotrexate, Skin, Annual general meeting, GREAT, Light, Sleep, Patient, Journal, Dermatitis, The Hills Shire, Azathioprine, American Academy, Pharmaceutical industry

"Atopic dermatitis is the most common inflammatory skin condition with an increasing number of available systemic interventions.

Key Points: 
  • "Atopic dermatitis is the most common inflammatory skin condition with an increasing number of available systemic interventions.
  • Competing treatment options exist for atopic dermatitis, but uncertainty regarding their comparative effectiveness still remains, the study showed.
  • Researchers examined the benefits and harms of all systemic and phototherapy treatments for atopic dermatitis in this network meta-analysis.
  • In randomized, controlled trials addressing systemic and phototherapy treatments for atopic dermatitis from MEDLINE, EMBASE, CENTRAL, Web of Science and GREAT, researchers performed Bayesian random-effects network meta-analyses on atopic dermatitis severity, itch severity, sleep disturbance, quality of life, exacerbations and adverse events.

Human medicines European public assessment report (EPAR): Libmyris, adalimumab, Date of authorisation: 12/11/2021, Revision: 2, Status: Authorised

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星期五, 一月 5, 2024
Marketing, INN, Axial spondyloarthritis, Tissue, Heart, Cancer, Inflammation, Red, Ankylosing spondylitis, Infection, Back pain, Anatomy, Ulcer, IIA, Skin, Hidradenitis suppurativa, Tuberculosis, Bone marrow, ATC, Joint, Hidradenitis, Pain, Psoriatic arthritis, Bleeding, Disease, Nose, Blood, Safety, Heart failure, Rheumatoid arthritis, Patient, Medical Subject Headings, Pediatrics, Immune system, Ulcerative colitis, International, HS, Lupus, Arthritis, Language, Mouth, Laboratory, Scar, Child, Select, Methotrexate, TNF, Axial, Headache, Swelling, Stevens–Johnson syndrome, European Medicines Agency, Spine, Abscess, Rash, Frankincense

Human medicines European public assessment report (EPAR): Libmyris, adalimumab, Date of authorisation: 12/11/2021, Revision: 2, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Libmyris, adalimumab, Date of authorisation: 12/11/2021, Revision: 2, Status: Authorised

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
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): Leflunomide medac, leflunomide, Date of authorisation: 27/07/2010, Revision: 19, Status: Authorised

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星期二, 一月 2, 2024
Medical Subject Headings, Marketing, Arava, European Commission, Arthritis, INN, Risk, ATC, Joint, Hepatotoxicity, DMARD, International, European, Disease, Language, Rheumatoid arthritis, Inflammation, Disease-modifying antirheumatic drug, Lymphocyte, Tablet, Select, Committee, Patient, Risk management, Anatomy, Medicine, Psoriatic arthritis, Methotrexate, IIA, CHMP, Skin, Medical device

Human medicines European public assessment report (EPAR): Leflunomide medac, leflunomide, Date of authorisation: 27/07/2010, Revision: 19, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Leflunomide medac, leflunomide, Date of authorisation: 27/07/2010, Revision: 19, Status: Authorised