Ankylosing spondylitis

Breakthroughs in Kexing Biopharm's Overseas Efforts: Qualification of Two Licensed Products for GMP Audits in Egypt

Retrieved on: 
Tuesday, April 2, 2024
Ulcerative colitis, Psoriasis, Rheumatoid arthritis, Growth, Ankylosing spondylitis, Drug, EDA, Ageing, Kingdom Holding Company, Crohn's disease, Lung cancer, GMP, Bevacizumab, Infliximab, Pharmaceutical industry

In 2022, Kexing Biopharm secured agreements with 24 overseas market customers and commenced the submission of local drug access registration documents.

Key Points: 
  • In 2022, Kexing Biopharm secured agreements with 24 overseas market customers and commenced the submission of local drug access registration documents.
  • The product underwent GMP audits in Egypt, Brazil, and Indonesia respectively in September 2023, February 2024, and March 2024.
  • In 2022, Kexing Biopharm swiftly reached agreements with 23 overseas market customers, initiating the submission of drug access registration documents.
  • By establishing local subsidiaries, Kexing Biopharm strives to accelerate product registration processes and enhance competitiveness in overseas markets.

FDA Accepts Supplemental Biologics License Applications for BIMZELX® (bimekizumab-bkzx) for Moderate-to-Severe Hidradenitis Suppurativa and Additional 2mL Device Presentations

Retrieved on: 
Thursday, April 4, 2024
Week, Psoriasis, Ankylosing spondylitis, Patient, UCB, HS, Psoriatic arthritis, Injection, Safety, FDA, Food, Pharmaceutical industry

In addition, a second sBLA for the BIMZELX 2mL device presentations has also been accepted.

Key Points: 
  • In addition, a second sBLA for the BIMZELX 2mL device presentations has also been accepted.
  • "We are excited to share progress on our FDA applications.
  • "In addition, the sBLA for the 2mL device presentations aims to offer increased convenience for patients.
  • Approval of the 2mL device presentations would mean that patients would have an alternative one-injection regimen option."

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

Retrieved on: 
Wednesday, April 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.

MoonLake announces significant improvements with Nanobody® sonelokimab over 24 weeks in active psoriatic arthritis (PsA) and other important updates at its R&D Day

Retrieved on: 
Sunday, March 10, 2024
Psoriatic arthritis, ACR, Doctor of Philosophy, Adalimumab, Skin, American College, Webcast, Moonlake, HS, Patient, Psoriasis, VELA, MMSc, ARGO, MIRA, EDT, Physician, Inflammation, Safety, Prognosis, Clinical trial, Ankylosing spondylitis, TNF, IL-17A, MDA, American Academy, EMA, Medical college, FDA, Food, Steroid, Prevalence, AAD, Event, Joint, PASI, Hidradenitis suppurativa, PSA, PPP, Disease, Porokeratosis, Medicine, Pharmaceutical industry

In addition, by week 24, over 80% and 60% of patients treated with sonelokimab achieved Psoriasis Area Severity Index (PASI) 90 and 100, respectively.

Key Points: 
  • In addition, by week 24, over 80% and 60% of patients treated with sonelokimab achieved Psoriasis Area Severity Index (PASI) 90 and 100, respectively.
  • Treatment with sonelokimab resulted in unprecedented improvements in composite scores that reflect responses in different domains simultaneously.
  • In all composite scores, sonelokimab showed 16-29 percentage point differences to the reference adalimumab arm, comparatively higher to competitors using the same reference arm.
  • The discontinuation rate of the second part of ARGO remained low at 5%, in line with other sonelokimab trials.

Alvotech and Teva Announce U.S. Approval of SIMLANDI® (adalimumab-ryvk) injection, the first interchangeable high-concentration, citrate-free biosimilar to Humira®

Retrieved on: 
Saturday, February 24, 2024
Pharmacy, Ulcerative colitis, Psoriasis, Uveitis, Ankylosing spondylitis, TEVA, Marketing, FDA, Partnership, Food, Teva Pharmaceuticals, Volunteering, Biosimilar, IC, Safety, Juvenile idiopathic arthritis, Rheumatoid arthritis, Hidradenitis suppurativa, Patient, Prescription, Environment, Generic drug

Teva is Alvotech’s strategic partner for the exclusive commercialization of SIMLANDI in the United States.

Key Points: 
  • Teva is Alvotech’s strategic partner for the exclusive commercialization of SIMLANDI in the United States.
  • SIMLANDI is the first high-concentration, citrate-free biosimilar to Humira that has been granted an interchangeability status by the FDA, and will qualify for interchangeable exclusivity for the 40mg/0.4ml injection.
  • An interchangeable biosimilar may be substituted at the pharmacy without consulting the prescriber, much like generic drugs are routinely substituted for brand name drugs.
  • Alvotech handles development and manufacturing, and Teva is responsible for U.S. commercialization, which leverages Teva’s extensive experience and sales and marketing infrastructure.

United States HUMIRA Market Analysis, Size, Forecast, and Insights Report, 2019-2023 and 2024-2032 - ResearchAndMarkets.com

Retrieved on: 
Friday, March 1, 2024
Pharmaceutical, Health, Clinical Trials, Psoriatic arthritis, Ulcerative colitis, JIA, Crohn's disease, Psoriasis, Ankylosing spondylitis, Uveitis, Adalimumab, SWOT, Juvenile idiopathic arthritis, UC, AbbVie, Rheumatoid arthritis, Hidradenitis suppurativa, Clinical trial, HS, TNF, Research, Pharmaceutical industry

The "US HUMIRA Market Size, Forecast, and Market Insight - 2032" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "US HUMIRA Market Size, Forecast, and Market Insight - 2032" report has been added to ResearchAndMarkets.com's offering.
  • This report provides comprehensive insights about HUMIRA for autoimmune uveitis in the US.
  • Further, it also consists of future market assessments inclusive of the HUMIRA market forecast analysis for autoimmune uveitis in the US, SWOT, analysts' views, comprehensive overview of market competitors, and brief about other emerging therapies in autoimmune uveitis.
  • What are the other emerging products available and how are these giving competition to HUMIRA for autoimmune uveitis?

Alvotech and Teva Announce U.S. Approval of SIMLANDI® (adalimumab-ryvk) injection, the first interchangeable high-concentration, citrate-free biosimilar to Humira®

Retrieved on: 
Saturday, February 24, 2024
Biotechnology, FDA, Health, Pharmaceutical, Managed Care, Pharmacy, Ulcerative colitis, Psoriasis, Uveitis, Ankylosing spondylitis, Multimedia, TEVA, Marketing, Teva, Partnership, Food, Teva Pharmaceuticals, Volunteering, Biosimilar, IC, Safety, Juvenile idiopathic arthritis, Rheumatoid arthritis, Hidradenitis suppurativa, Patient, Prescription, Environment, Generic drug

Teva is Alvotech’s strategic partner for the exclusive commercialization of SIMLANDI in the United States.

Key Points: 
  • Teva is Alvotech’s strategic partner for the exclusive commercialization of SIMLANDI in the United States.
  • An interchangeable biosimilar may be substituted at the pharmacy without consulting the prescriber, much like generic drugs are routinely substituted for brand name drugs.
  • As the only interchangeable adalimumab biosimilar with the high-concentration formulation, SIMLANDI can be substituted for Humira at the pharmacy level, subject to state pharmacy laws.
  • Alvotech handles development and manufacturing, and Teva is responsible for U.S. commercialization, which leverages Teva’s extensive experience and sales and marketing infrastructure.

Global IL-17 Biologics Market Research Report 2023: Secukinumab, Ixekizumab, Bimekizumab, Brodalumab Market Insights and Forecasts, 2019-2022 and 2024-2030 - ResearchAndMarkets.com

Retrieved on: 
Wednesday, February 21, 2024
Biotechnology, Health, Science, Pharmaceutical, Research, Engineering, Psoriasis, Autoimmune disease, Ankylosing spondylitis, USD, Inflammation, Conditional sentence, Growth, Prevalence, Safety, Secukinumab, Patient, Statistics, Research report, Edition

The "Global IL-17 Biologics Market (2023 Edition): Analysis By Indication, By Drug (Secukinumab, Ixekizumab, Bimekizumab, Brodalumab), By Region, By Country: Market Insights and Forecast (2024-2030)" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Global IL-17 Biologics Market (2023 Edition): Analysis By Indication, By Drug (Secukinumab, Ixekizumab, Bimekizumab, Brodalumab), By Region, By Country: Market Insights and Forecast (2024-2030)" report has been added to ResearchAndMarkets.com's offering.
  • The Global IL-17 Biologics Market is expected to generate USD 10.9 Billion by the end of 2030, up from USD 4.37 Billion in 2022.
  • During the forecast period, 2024-2030, Global IL-17 Biologics is expected to expand at a CAGR of 12.3 %.
  • Additionally, the research report presents data including market size, yearly growth & potential analysis, the competitive study of market players, investment opportunities and demand forecast.

Mallinckrodt Announces U.S. FDA Approval of Supplemental New Drug Application for Acthar® Gel (repository corticotropin injection) Single-Dose Pre-filled SelfJect™ Injector

Retrieved on: 
Friday, March 1, 2024
Chorioretinitis, Natural history, Caregiver, New Drug Application, Ankylosing spondylitis, Optic neuritis, Education, FDA, Food, Adnexa, Shanda, Uveitis, Eye, Adrenocorticotropic hormone, Multiple sclerosis, Condylar resorption, Safety, Rheumatoid arthritis, Patient, Sclerosis, Disease, Keratitis, MRCP, Insurance, Pharmaceutical industry

DUBLIN, March 1, 2024 /PRNewswire/ -- Mallinckrodt plc, a global specialty pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved Mallinckrodt's supplemental New Drug Application (sNDA) for the Acthar® Gel (repository corticotropin injection) Single-Dose Pre-filled SelfJect™ Injector (herein referred to as "SelfJect"), a new delivery device for Acthar Gel for appropriate patients with a range of chronic and acute inflammatory and autoimmune conditions.2 SelfJect is intended to provide the appropriate subcutaneous dose of Acthar Gel, as prescribed by a healthcare professional, and is designed to help give patients control of their administration.1,3

Key Points: 
  • "We're excited to bring this innovation to U.S. patients with chronic and acute inflammatory and autoimmune conditions.
  • Mallinckrodt also offers a team of field-based experts who provide education for healthcare professionals on the reimbursement process as well as tools available for patients.
  • Acthar Gel will continue to be available as an injection with a vial and syringe.
  • Controlled clinical trials have shown Acthar to be effective in speeding the resolution of acute exacerbations of multiple sclerosis.

New Study Finds People With Inflammatory Arthritis Are More Likely To Seek Mental Health Care

Retrieved on: 
Wednesday, January 24, 2024
Anxiety, Psoriatic arthritis, Rheumatoid arthritis, Ankylosing spondylitis, Inflammatory arthritis, Research, Disease, Conditional sentence, Diagnosis, Depression, Pharmaceutical industry

A recent study conducted by a team of scientists at Arthritis Research Canada has found a link between IA and the need for mental health treatment and medication.

Key Points: 
  • A recent study conducted by a team of scientists at Arthritis Research Canada has found a link between IA and the need for mental health treatment and medication.
  • This research aimed to describe patterns of depression and anxiety health care before and after a diagnosis among people with IA, including: ankylosing spondylitis, psoriatic arthritis, and rheumatoid arthritis.
  • "The results of this study are revealing, but this is only a starting point," said Dr. Alyssa Howren, Research Trainee at Arthritis Research Canada.
  • "We need additional research to investigate alternative explanations as to why people with inflammatory arthritis have a higher requirement for mental health care and medication."