Search Results for “arthritis” – Page 5 – media

Acelyrin’s izokibep for hidradenitis suppurativa reveals positive results

Acelyrin has shared positive results from a late-stage study of its IL-17A inhibitor izokibep in hidradenitis suppurativa (HS), but has said it will not be moving forward with the asset in this indication. Estimated to affect about 1% of the population in most studied countries, HS is a chronic inflammatory skin condition that causes painful nodules and abscesses. In the phase 3 trial, izokibep demonstrated statistically significant responses across multiple efficacy endpoints at week 12, with 33% of patients being treated with izokibep 160mg weekly achieving at least a 75% reduction in total abscess and inflammatory nodule count (HiSCR75) compared to 21% of those receiving placebo. Results also showed that 25% and 22% of izokibep-treated patients achieved HiSCR90 and HiSCR100, respectively, compared to 9% and 8% in the placebo cohort. The announcement comes shortly after the drug demonstrated promising results in a phase 2b/3 study for psoriatic arthritis (PsA), a ...
- Source: drugdu
- 66
- August 30, 2024
An Upcoming White House Decision May Jeopardize Americans’ Access to Life-Saving Drugs

The White House might soon finalize a rule that will either save or cost patients billions of dollars in prescription drug costs. The rule concerns “copay accumulators,” which are programs health plans use to prevent copay assistance from counting toward patients’ deductibles or out-of-pocket maximums. By Katie AdamsThe White House could soon finalize a rule that will either save or cost patients billions of dollars in prescription drug costs. The rule concerns “copay accumulators,” which are programs health plans use to prevent copay assistance from counting toward patients’ deductibles or out-of-pocket maximums. Typically, when patients receive copay assistance from pharmaceutical companies, the amount paid by the manufacturer helps reduce the patient’s out-of-pocket costs. But with copay accumulators, the assistance from the drugmaker is not counted toward the patient’s maximum limit on out-of-pocket expenses. In September of last year, Judge John D. Bates of the U.S. District Court for the District ...
- Source: drugdu
- 91
- August 13, 2024
Hengrui Pharmaceuticals’ Innovative Drug Fronachizumab Approved for Clinical Trials for the Treatment of Moderate to Severe Plaque Psoriasis in Children and Adolescents

Recently, Hengrui Pharmaceuticals’ subsidiary, Suzhou Shengdia Bio-pharmaceutical Co., Ltd. has received a Notice of Approval for Clinical Trial of Drugs issued by the State Drug Administration, agreeing to conduct a clinical trial for the treatment of moderate-to-severe plaque psoriasis in children and adolescents aged 6 to less than 18 years old, who are suitable for systemic therapy or phototherapy. Psoriasis is a chronic, relapsing, immune-mediated inflammatory skin disease that most often involves the scalp, knees, elbows, hands and feet. The prevalence of psoriasis ranges from 0.09% to 11.4% of the global population [1][2], and the prevalence of psoriasis in our country is about 0.5% [3]. About 80%-90% of psoriasis cases are of the common type of psoriasis (plaque psoriasis) and 10%-20% of cases are of moderate to severe psoriasis involving more than 5% of the body surface area (BSA) [4]. It is estimated that approximately 1/3 of adults with psoriasis ...
- Source: drugdu
- 82
- August 12, 2024
Janssen’s psoriasis drug shows promise for childhood diabetes

A new study led by researchers from Cardiff University, King’s College London (KCL), Swansea University and the University of Calgary has revealed that Janssen’s psoriasis drug, Stelara (ustekinumab), shows promise in treating childhood diabetes. Published in Nature Medicine and funded by a Medical Research Council and National Institute for Health and Care Research partnership, the study found that Stelara was more effective in treating the early stages of type 1 diabetes (T1D) in children and adolescents. Accounting for approximately 10% of diabetes cases in the UK, T1D occurs when the pancreas does not produce insulin or makes very little insulin. Since 2009, the immunotherapy Stelara has been used to treat psoriasis, a skin condition characterised by flaky patches of skin that affects around 60 million people globally, as well as other immune conditions, including psoriatic arthritis, severe Crohn’s disease and severe ulcerative colitis. In the study, researchers tested Stelara in ...
- Source: drugdu
- 70
- August 9, 2024
FDA approves Sun Pharma’s JAK inhibitor for alopecia

Sun Pharmaceutical Industries has secured the US Food and Drug Administration (FDA) approval for its oral Janus kinase (JAK) Inhibitor Leqselvi (deuruxolitinib) to treat severe alopecia areata. Originally developed by Concert Pharmaceuticals, Sun Pharma inherited the asset when it purchased Concert Pharmaceuticals in January 2023 for $576m. Alopecia areata is an autoimmune condition where the immune system attacks hair follicles, leading to sudden, patchy hair loss. JAK inhibitors such as Leqselvi block the activity of Janus kinase enzymes, which are involved in the signalling pathways that drive inflammation and immune responses. The FDA approval is based on data gathered from two Phase III studies—THRIVE-AA1 and THRIVE-AA2 (NCT04518995 and NCT04797650)—where Leqselvi restored scalp hair coverage by at least 80% in more than 30% of patients after 24 weeks. The 1,220 patients enrolled across the two studies had alopecia areata with at least 50% scalp hair loss as measured by Severity of ...
- Source: drugdu
- 121
- July 29, 2024
Artiva’s IPO Reels In $167M to Bring NK Cell Therapy to Autoimmune Diseases

Lupus is the lead autoimmune indication for Artiva Biotherapeutics, which has an early-stage clinical trial underway. Artiva’s allogeneic cell therapies are based on natural killer cells. By Frank VinluanCell therapy first reached patients as treatments for cancer. Artiva Biotherapeutics is part of a growing group of companies working to bring cell therapy to autoimmune disease, and its IPO has raised $167 million for clinical trial plans. Artiva priced the IPO at $12 per share, which was below the $14 to $16 per share price range the biotech set in preliminary terms last week. However, it boosted the deal size by increasing the number of shares in the offering. The 8.7 million shares it initially planned to offer would have raised $130.5 million at the proposed pricing midpoint. The company was able to raise more by selling 13.92 million shares. The shares of San Diego-based Artiva shares debuted on the Nasdaq ...
- Source: drugdu
- 76
- July 23, 2024
AbbVie looks to add an eighth indication for JAK inhibitor Rinvoq

AbbVie is set to expand the indication list for its immunology blockbuster, Rinvoq (upadacitinib). The company has submitted applications to both the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) to seek approval for the use of Rinvoq as a treatment for giant cell arteritis. Rinvoq blocks the activity of Janus kinase (JAK) enzymes in the JAK-STAT signalling pathway, which plays a role in the release of pro-inflammatory cytokines. It has been approved by the FDA to treat seven autoimmune conditions, namely atopic dermatitis, ankylosing spondylitis, axial spondylarthritis, Crohn’s disease, psoriatic arthritis, rheumatoid arthritis, and ulcerative colitis. Rinvoq is one of the top revenue-generating therapies for AbbVie, raking in approximately $4bn in sales last year, per the company’s financials. The therapy’s revenue is expected to soar over the next decade, with Rinvoq expected to pull in over $12bn in sales by 2030, as ...
- Source: https://www.pharmaceutical-technology.com/news/abbvie-looks-to-add-an-eighth-indication-for-jak-inhibitor-rinvoq/
- 85
- July 17, 2024
FDA Says ‘No’ to Novo Nordisk’s Once-Weekly Insulin

The FDA rejected Novo Nordisk’s biologics license application for icodec, citing questions about the manufacturing process for this once weekly insulin as well as its use by type 1 diabetes patients. But there are several high-profile FDA approvals in our recap of recent regulatory news. By Frank VinluanNovo Nordisk’s bid to bring diabetes patients a less burdensome dosing regimen has encountered a setback. The FDA turned down the company’s application for icodec, a slow-acting insulin the company designed for once-weekly dosing as an alternative to daily insulin injections. According to Novo Nordisk, the FDA’s complete response letter raised questions about icodec’s manufacturing process as well as the use of the product in patients with type 1 diabetes. In May, an FDA advisory committee concluded that the available data were not sufficient to show that icodec’s benefits outweigh its risks in type 1 diabetes. Some committee members expressed concerns about icodec’s ...
- Source: drugdu
- 100
- July 16, 2024
Eli Lilly Shows Appetite for Oral Immunology Drugs, Swallowing Morphic in $3.2B Deal

Eli Lilly’s Morphic acquisition brings an oral small molecule that blocks the same target as Entvyio, an injectable inflammatory bowel disease drug from Takeda Pharmaceutical. The Morphic deal follows Lilly’s 2023 acquisition of Dice Therapeutics, another company developing oral immunology medications. By Frank VinluanEli Lilly has immunology and inflammation products administered by injection, but the pharmaceutical giant is among the companies interested in bringing patients more convenient pill formulations. Its $3.2 billion acquisition of Morphic comes with a lead drug candidate that’s an oral small molecule in mid-stage development for inflammatory bowel disease. According to deal terms announced Monday, Lilly is paying $57 in cash for each share of Waltham, Massachusetts-based Morphic. That price represents a 79% premium to Morphic’s closing stock price on Friday. The deal, which has been approved by the boards of directors of both companies, is expected to close in the third quarter of this year. ...
- Source: drugdu
- 106
- July 10, 2024
TOFIDENCE (BAT1806/BIIB800), a biosimilar developed by BIO-THERA with reference to Amero® (tolizumab), received marketing approval from the European Commission.

BIO-THERA Biopharmaceutical Co., Ltd (SSE: 688177) is a global science-based and innovative biopharmaceutical company based in Guangzhou, China, hereinafter referred to as “BIO-THERA” or the “Company”. The Company is focused on developing a new generation of innovative drugs and biosimilars for the treatment of oncology, autoimmune diseases, cardiovascular diseases, ophthalmology and other major diseases that threaten human life or health. The Company’s partner, Bojian (NASDAQ: BIIB), recently received notification from the European Commission that it has granted marketing approval to BIO-THERA for the treatment of moderate to severe rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis, and other diseases. The approval follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) in April 2024 for the treatment of moderate to severe rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis, and COVID-19. The European Commission’s approval of the marketing application for TOFIDENCE (BAT1806/BIIB800) ...
- Source: drugdu
- 67
- June 28, 2024

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