Immunosuppressants

Advisory - Health Canada has initiated a safety review on Xeljanz and Xeljanz XR (tofacitinib), used to treat arthritis and ulcerative colitis

Retrieved on: 
Tuesday, April 6, 2021
Medical specialties, Clinical medicine, Medicine, Autoimmune diseases, Rheumatology, Immunosuppressants, Arthritis, Psoriasis, Tofacitinib, Ulcerative colitis, Psoriatic arthritis, Rheumatoid arthritis

Product:Xeljanz and Xeljanz XR (tofacitinib), a prescription drug used to treat rheumatoid arthritis, psoriatic arthritis and ulcerative colitis.

Key Points: 
  • Product:Xeljanz and Xeljanz XR (tofacitinib), a prescription drug used to treat rheumatoid arthritis, psoriatic arthritis and ulcerative colitis.
  • What to do:Do not stop or change your dose of Xeljanz or Xeljanz XR (tofacitinib) without first talking to your health care professional.
  • Health Canada is informing Canadians and health care professionals that it is conducting a safety review of Xeljanz and Xeljanz XR (tofacitinib) after a clinical trial identified an increased risk of serious heart-related issues and cancer in trial participants.
  • Xeljanz and Xeljanz XR (tofacitinib) is a prescription drug used to treat adults with moderate to severely active rheumatoid arthritis, active psoriatic arthritis, or moderate to severely active ulcerative colitis who have not responded well to other medications.

Adalimumab: Sold Under the Brand Name Humira - Global Biosimilar Insight Report 2021 - ResearchAndMarkets.com

Retrieved on: 
Friday, April 2, 2021
Managed care, Pharmaceutical, Health, Medical specialties, Clinical medicine, Medicine, Monoclonal antibodies, TNF inhibitors, Biotechnology, Immunosuppressants, Autoimmune diseases, Adalimumab, Book:Mabs, Infliximab

The "Adalimumab - Biosimilar Insight, 2021" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Adalimumab - Biosimilar Insight, 2021" report has been added to ResearchAndMarkets.com's offering.
  • This "Adalimumab - Biosimilar Insight, 2021," report provides comprehensive insights about 34+ companies and 35+ marketed and pipeline drugs in Adalimumab Biosimilars landscape.
  • Adalimumab, sold under the brand name Humira among others, is a medication used to treat rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, psoriasis, hidradenitis suppurativa, uveitis, and juvenile idiopathic arthritis.
  • In July 2020, the FDA has approved an adalimumab biosimilar (Hulio) from Fujifilm Kyowa Kirin Biologics, making it the sixth adalimumab biosimilar to AbbVie's reference product Humira that has been approved and the 28th biosimilar approved by the FDA.

Kiniksa Announces Commercial Availability of ARCALYST ® (rilonacept) for Recurrent Pericarditis

Retrieved on: 
Thursday, April 1, 2021
Medical specialties, Health care, Orphan drugs, Clinical medicine, Immunosuppressants, Rilonacept, Pericarditis, Breakthrough therapy

We are excited to announce that ARCALYST is now available as the first and only approved therapy for patients with recurrent pericarditis, said Ross Moat, ARCALYST General Manager.

Key Points: 
  • We are excited to announce that ARCALYST is now available as the first and only approved therapy for patients with recurrent pericarditis, said Ross Moat, ARCALYST General Manager.
  • Kiniksa is committed to patient access and has established Kiniksa One Connect, our patient support program, which provides comprehensive access and support services for any patient prescribed ARCALYST.
  • Patients who have additional pericarditis episodes following a symptom-free period of 4-6 weeks are identified as having recurrent pericarditis.
  • The FDA granted Breakthrough Therapy designation to ARCALYST for the treatment of recurrent pericarditis in 2019 and Orphan Drug designation to ARCALYST for the treatment of pericarditis in 2020.

Celltrion Healthcare receives positive CHMP opinion for subcutaneous formulation of infliximab, Remsima® SC, for direct use of subcutaneous therapy without IV loading in adults with rheumatoid arthritis

Retrieved on: 
Wednesday, March 31, 2021
Health, Medical devices, Stem cells, Research, Science, Pharmaceutical, Biotechnology, Medical specialties, Clinical medicine, Drugs, Rheumatology, Immunosuppressants, TNF inhibitors, Monoclonal antibodies, Infliximab, Janssen Pharmaceutica, Celltrion, Rheumatoid arthritis, Arthritis

For existing patients, Remsima SC is administered without additional IV loading 8 weeks after last administration of the infliximab IV.

Key Points: 
  • For existing patients, Remsima SC is administered without additional IV loading 8 weeks after last administration of the infliximab IV.
  • Remsima SC without IV induction can generate additional saving of 14 million GBP.
  • Remsima IV is usually given as 3 mg per kg/body weight in rheumatoid arthritis (RA) and as 5 mg per kg/body weight for the other indications.
  • Celltrion Healthcare endeavours to offer high-quality cost-effective solutions through an extensive global network that spans more than 110 different countries.

Global TNF Alpha Inhibitors Markets 2020-2030: Remicade (infliximab), Enbrel (etanercept), Humira (adalimumab), Cimzia (certolizumab pegol), & Simponi (golimumab)

Retrieved on: 
Tuesday, March 30, 2021
Drugs, Medical specialties, Monoclonal antibodies, TNF inhibitors, Immunosuppressants, Biotechnology, Janssen Biotech, Infliximab, Etanercept, Golimumab, Adalimumab, Certolizumab pegol

The TNF alpha inhibitors market consists of sales of tumor necrosis factor-alpha (TNF-) inhibitors by entities that manufacture TNF alpha inhibitors.

Key Points: 
  • The TNF alpha inhibitors market consists of sales of tumor necrosis factor-alpha (TNF-) inhibitors by entities that manufacture TNF alpha inhibitors.
  • The TNF alpha inhibitors market covered in this report is segmented by drug into remicade (infliximab); enbrel (etanercept); humira (adalimumab); cimzia (certolizumab pegol); simponi (golimumab).
  • The adverse side effects of TNF alpha inhibitors on patients are expected to limit the growth of the TNF alpha inhibitors market.
  • Global TNF Alpha Inhibitors Market, Segmentation By Drug, Historic and Forecast, 2015-2019, 2023F, 2025F, 2030F, $ Billion

Samsung Bioepis Continues Global Market Expansion with Launch of HADLIMA™ in Australia and Canada in partnership with Merck & Co.

Retrieved on: 
Monday, March 29, 2021
Drugs, Medical specialties, Health care, Immunosuppressants, TNF inhibitors, Monoclonal antibodies, Biotechnology, Adalimumab, Immunology, Etanercept, Infliximab, Biosimilar

With the launch in Australia, Samsung Bioepis adalimumab is now available in three markets: Europe, Canada, and Australia, underscoring the companys continuous efforts to expand its reach in multiple markets across the world.

Key Points: 
  • With the launch in Australia, Samsung Bioepis adalimumab is now available in three markets: Europe, Canada, and Australia, underscoring the companys continuous efforts to expand its reach in multiple markets across the world.
  • We are delighted by our partnership with MSD Australia to bring this important medicine to patients in Australia, followed by our recent launch in Canada, said Albert Kim, Vice President of the Commercial Strategy Team at Samsung Bioepis.
  • HADLIMA is Samsung Bioepis third anti-TNF biosimilar launched in Australia, following the launch of BRENZYS (etanercept) in December 2016 and RENFLEXIS (infliximab) in July 2017.
  • In addition to Australia and Canada, Samsung Bioepis adalimumab has obtained the approval for marketing in Europe, Switzerland,the US and Korea.

Janssen Receives Positive CHMP Opinion for PONVORY™ ▼ (ponesimod) for the Treatment of Adults With Relapsing Forms of Multiple Sclerosis With Active Disease Defined by Clinical or Imaging Features

Retrieved on: 
Friday, March 26, 2021
Biotechnology, Health, Pharmaceutical, Managed care, Oncology, Multiple sclerosis, Immunosuppressants, Medical specialties, Johnson & Johnson, Health care, Medicine, Beerse, Janssen Pharmaceuticals, Medical research, Janssen, Ponesimod, Ponesimod, Multiple Sclerosis, the Janssen Pharmaceutical Companies of Johnson & Johnson

If approved by the European Commission, ponesimod has the potential to help more people living with relapsing forms of MS.

Key Points: 
  • If approved by the European Commission, ponesimod has the potential to help more people living with relapsing forms of MS.
  • If approved, ponesimod will be the first therapy by Janssen for patients living with RMS with active disease defined by clinical or imaging features.
  • Janssen Research & Development, LLC and Janssen Pharmaceutica NV are part of the Janssen Pharmaceutical Companies of Johnson & Johnson.
  • Janssen Submits European Marketing Authorisation Application for Ponesimod for Treatment of Adults with Relapsing Multiple Sclerosis.

Alvotech Disputes AbbVie’s Recent Allegations

Retrieved on: 
Thursday, March 25, 2021
Biotechnology, Pharmaceutical, Health, Oncology, Life sciences, Drugs, Health sciences, Biotechnology, Pharmacy, Immunosuppressants, TNF inhibitors, Monoclonal antibodies, Adalimumab, Biosimilar, Biopharmaceutical, AbbVie

Alvotech strongly disputes AbbVies allegations of wrongdoing relating to AVT02, Alvotechs proposed biosimilar to HUMIRA (adalimumab).

Key Points: 
  • Alvotech strongly disputes AbbVies allegations of wrongdoing relating to AVT02, Alvotechs proposed biosimilar to HUMIRA (adalimumab).
  • Alvotech will vigorously defend against these allegations.
  • Indeed, Alvotech believes that the case may be part of a larger AbbVie strategy to delay an emerging competitor from providing patients with a lower-cost alternative to AbbVies HUMIRA high-concentration product.
  • Alvotech is a multinational biopharmaceutical company focused on the development and manufacture of high quality biosimilars for global markets.

Global TNF Alpha Inhibitors Market Report 2020-2030: COVID-19 Growth and Change - Market is Expected to Decline from $40.66 Billion in 2019 to $39.01 Billion in 2020 - ResearchAndMarkets.com

Retrieved on: 
Thursday, March 25, 2021
Health, Pharmaceutical, Drugs, Medical specialties, Clinical medicine, Monoclonal antibodies, TNF inhibitors, Immunosuppressants, Biotechnology, Cytokines, Tumor necrosis factor, Etanercept, Immunomodulatory imide drug

The "TNF Alpha Inhibitors Global Market Report 2020-30: COVID-19 Growth and Change" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "TNF Alpha Inhibitors Global Market Report 2020-30: COVID-19 Growth and Change" report has been added to ResearchAndMarkets.com's offering.
  • The TNF alpha inhibitors market consists of sales of tumor necrosis factor-alpha (TNF-) inhibitors by entities that manufacture TNF alpha inhibitors.
  • The adverse side effects of TNF alpha inhibitors on patients are expected to limit the growth of the TNF alpha inhibitors market.
  • Global TNF Alpha Inhibitors Market, Segmentation By Drug, Historic and Forecast, 2015-2019, 2023F, 2025F, 2030F, $ Billion

Phase 1 Trial Demonstrates Encouraging Clinical Benefit and Promising Safety Profile of Pacritinib for the Prevention of Graft-Versus-Host Disease Published in Clinical Cancer Research

Retrieved on: 
Monday, March 22, 2021
Medical specialties, Clinical medicine, Medicine, Transplantation medicine, Immunosuppressants, Macrolides, Immune system disorders, Hematology, Graft-versus-host disease, Sirolimus, Hematopoietic stem cell transplantation, Tacrolimus

The Phase 1 portion of the trial (NCT02891603) evaluated the safety of pacritinib when administered with sirolimus plus low-dose tacrolimus after allogeneic hematopoietic cell transplantation (alloHCT).

Key Points: 
  • The Phase 1 portion of the trial (NCT02891603) evaluated the safety of pacritinib when administered with sirolimus plus low-dose tacrolimus after allogeneic hematopoietic cell transplantation (alloHCT).
  • At this dose, one out of six study participants treated with the investigational regimen had Grade 2-4 acute GVHD.
  • Chronic GVHD was rare, with only two participants developing mild disease per NIH consensus criteria, which resolved without systemic immune suppression.
  • "The favorable safety profile to date and its impact on immune reconstitution after alloHCT make the PAC/SIR/TAC regimen a promising strategy to prevent GVHD.