Baiaotai Biopharmaceutical Co., Ltd. (stock code: 688177) is a global biopharmaceutical enterprise based on science and innovation located in Guangzhou, China, hereinafter referred to as “Baiaotai” or “the Company”. The company announced today that the article “Evaluating the Phase 3 Clinical Study of BAT1806/BIIB800 during the Second Treatment Phase (TP2, Weeks 24-48)” co authored with Bojian has been published in the Arthritis Research&Therapy journal. BAT1806/BIIB800 is a product developed by BioNTech and referenced by Yamero ® The biosimilar drug developed with tocilizumab has been launched in Europe and America under the brand name TOFIDENCE ™. In a phase 3 clinical study, rheumatoid arthritis patients with insufficient response to methotrexate were randomly assigned to three treatment groups in a 1:1:2 ratio: (1) using the original drug for intravenous injection of 8mg/kg every 4 weeks until week 48; (2) Treat with the original drug until week 24, then switch to using BAT1806/BIIB800 ...
The initiative’s proposals aim to tackle current challenges in health research and innovation The Innovative Health Initiative (IHI) has launched a new call for proposals, which include topics on cardiovascular disease (CVD) and arthritis, as part of the total budget worth €96.5m to tackle challenges in health research and innovation. As part of the total budget, Horizon Europe, the EU’s research and innovation programme, has contributed €47.6m, while an additional €40.9m comes from the IHI’s industry members, as well as €8.1m from IHI contributing partners. Dr Niklas Blomberg, executive director, IHI, commented: “This call for proposals is an excellent opportunity to be part of ambitious projects tackling major challenges in health research and innovation.” The IHI aims to identify and create models, interventions and best practices to improve the management of CVD in Europe’s cities, covering healthcare delivery, individual lifestyle changes and the living environment. It will include five pilot ...
Don Tracy, Associate Editor Approval for Kevzara was based on controlled studies, pharmacokinetic data from adults with rheumatoid arthritis, and pediatric-specific studies on pharmacokinetics. The FDA has approved Regeneron’s and Sanofi’s approved Kevzara (sarilumab) for the treatment of active polyarticular juvenile idiopathic arthritis (pJIA) in patients weighing over 138 lbs. According to a joint press release, the approval was based on results of controlled studies and pharmacokinetic data from adults with rheumatoid arthritis (RA), as well as pediatric-specific studies on pharmacokinetics, pharmacodynamics, dosing, and safety.1 “Polyarticular juvenile idiopathic arthritis can be a painful disease for children where multiple joints are impacted by this chronic inflammation,” said George D. Yancopoulos, MD, PhD, board co-chair, president, chief scientific officer, Regeneron, in a press release. “Not only are their daily lives impacted, but their futures can be disrupted without adequate treatment. The approval of Kevzara in polyarticular juvenile idiopathic arthritis provides these vulnerable ...
On June 4, AbbVie announced that the U.S. FDA approved the use of RINVOQ® (upadacitinib) for the treatment of pediatric patients two years of age and older with active polyarticular juvenile idiopathic arthritis (pJIA) and psoriatic arthritis (PsA) who have had an insufficient response to, or are intolerant of, one or more tumor necrosis factor (TNF) inhibitors. In addition, a new dosage form of RINVOQ® LQ (upadacitinib) oral solution, based on weight-based dosing, is now available in the U.S. for the pediatric population. Dr. Roopal Thakkar, Senior Vice President, Global Therapeutic Areas and Chief Medical Officer of AbbVie, said: “RINVOQ has always been an important addition to the treatment of a wide range of rheumatic diseases, helping adult patients achieve meaningful disease control. Now, AbbVie is proud to offer RINVOQ in tablets and oral solution for our younger patients. Nearly 300,000 children and adolescents in the U.S. have some form ...
Osteoarthritis (OA) is the most prevalent form of arthritis, impacting millions worldwide and resulting in significant economic and social costs. Although no cure exists currently, the effectiveness of emerging therapies might depend on early detection and slowing the disease’s progression before severe debilitation occurs. Traditional diagnostic methods typically do not catch the disease until it has already caused structural damage to the joint. For example, an abnormal X-ray can reveal definitive signs of knee OA, but by the time these signs are visible, the disease has often been advancing for years. Now, a novel blood test has been developed that can predict the onset of knee OA at least eight years before its signs become visible on X-rays. Researchers at Duke Health (Durham, NC, USA) validated the accuracy of the blood test, which detects key biomarkers of OA. Their findings indicate that the test not only predicts the onset of ...
Davy James Alvotech’s and Teva’s Selarsdi (ustekinumab-aekn), the second FDA-approved biosimilar to Stelara, is indicated to treat patients aged 6 years and above with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy and for patients aged 6 years and above with active psoriatic arthritis. Image credit: Maria | stock.adobe.com Alvotech’s and Teva Pharmaceuticals’ Selarsdi (ustekinumab-aekn) has been approved by the FDA as a biosimilar to Stelara (ustekinumab), which represents the second approval for a Stelara biosimilar.1 Selarsdi is indicated to treat patients aged 6 years and above with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy; and for patients aged 6 years and above with active psoriatic arthritis. “The approval of Selarsdi—which is our second biosimilar approval this year—underscores Teva’s commitment to expanding the availability, access and uptake of this important treatment option to patients in the US,” Thomas Rainey, ...
On January 9, 2024, NOVARTIS China announced that its innovative biologic Cosentyx® (stavudine) was approved by the NMPA for the treatment of adult patients with active psoriatic arthritis. This is the third indication for which Cosentyx® has been approved in China, following “moderate-to-severe plaque psoriasis” and “ankylosing spondylitis”. Psoriasis is an immune-related, chronic, relapsing, inflammatory, systemic disease. Currently, there are more than 7 million psoriasis patients in China. Psoriatic arthritis (PsA) is an inflammatory arthropathy closely related to psoriasis, with most patients experiencing joint symptoms secondary to skin lesions, and a few patients experiencing joint symptoms prior to or concurrently with skin lesions. Joint symptoms may include swelling, pain, morning stiffness and limited joint movement. Psoriatic arthritis is prone to recurrence. If not treated in time, the long-term inflammation caused by psoriatic arthritis will bring irreversible structural damage to the joints, which will seriously affect the patient’s physical function and ...
Janssen, a Johnson & Johnson company, has announced positive results from a mid-stage study of its investigational FcRn inhibitor in rheumatoid arthritis (RA). The phase 2a IRIS-RA trial has been evaluating nipocalimab in adults with moderate-to-severe RA who have tested positive for anti-citrullinated protein antibodies (ACPAs) or rheumatoid factor (RF) and had an inadequate response or been intolerant to at least one anti-TNF therapy. Approximately 13 million people worldwide are affected by RA, a chronic inflammatory disease that causes joint pain, swelling and stiffness, and in some cases, permanent damage and deformity in structural joint elements such as cartilage and bone. The presence of autoantibodies is a distinctive feature of RA, with ACPAs and RF being two autoantibody systems commonly used as aids for diagnosing and classifying the disease. Results from IRIS-RA showed that nipocalimab reduced levels of circulating IgG antibodies, including ACPAs, indicating they may play a key role ...
Amgen has announced positive new research evaluating the use of its inflammatory disease medication Otezla (apremilast) in psoriatic arthritis. Psoriatic arthritis is a chronic, inflammatory form of arthritis estimated to affect nearly 38 million people worldwide. The condition can cause swelling, stiffness and pain in and around the joints that worsens over time and can decrease physical function. Otezla regulates inflammation by inhibiting an enzyme known as phosphodiesterase 4. This enzyme controls much of the inflammatory action within cells, which can affect the level of inflammation associated with psoriatic disease. The new data for the drug, being presented at the 2023 European Congress of Rheumatology (EULAR), includes results from the phase 4 MOSAIC study, which evaluated its effect on joint inflammation and structural progression of psoriatic arthritis using MRI. Results showed that patients treated with Otezla had improvements in both clinical and MRI measures of inflammation up to week 48, ...
Wake Forest Institute for Regenerative Medicine (WFIRM) scientists have created a promising injectable cell therapy to treat osteoarthritis that both reduces inflammation and also regenerates articular cartilage. Recently identified by the Food and Drug Administration as a public health crisis, osteoarthritis affects more than 520 million people worldwide who deal with pain and inflammation. Osteoarthritis is typically induced by mechanical or traumatic stress in the joint, leading to damaged cartilage that cannot be repaired naturally. “Without better understanding of what drives the initiation and progression of osteoarthritis, effective treatment has been limited,” said lead author Johanna Bolander of WFIRM. “Initially, we studied what goes wrong in osteoarthritic joints, compared these processes to functional environments, and used this information to develop an immunotherapy cell treatment.” Osteoarthritis is a disease of the joint system. The joint includes a synovial membrane—a connective tissue that lines the inner surface of the joint. The membrane functions to protect the joint ...
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