Search Results for “Janssen” – media

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
- 68
- August 9, 2024
BigHat Biosciences partners with Janssen Biotech

Strategic collaboration to leverage BigHat’s AI/ML (Artificial Intelligence / Machine Learning) guided Milliner platform to design high-quality next-generation protein therapeutics BigHat Biosciences, a biotechnology company with an artificial intelligence/machine learning-guided antibody discovery and development platform announced a collaboration with Janssen Biotech Inc., a Johnson & Johnson company. This strategic collaboration combines the drug discovery, clinical development and data science expertise from Johnson & Johnson with BigHat’s Milliner platform, a suite of machine learning technologies integrated with a high-speed wet lab, to guide the design and selection for high-quality antibodies for multiple Neuroscience therapeutic targets. The agreement was facilitated by Johnson & Johnson Innovation. BigHat’s antibody design platform, Milliner, integrates a synthetic biology-based high-speed wet lab with machine learning technologies into a full-stack antibody discovery and engineering platform, to engineer antibodies with more complex functions and better biophysical properties. This approach reduces the difficulty of designing antibodies and other therapeutic proteins ...
- Source: drugdu
- 107
- May 5, 2024
Janssen reveals positive results for nipocalimab in rheumatoid arthritis

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 ...
- Source: drugdu
- 103
- November 13, 2023
Janssen Sends Data for Phase III Children’s Pulmonary Tuberculosis Treatment to FDA and EMA

Don Tracy, Associate Editor Company aims to receive approval on a Type II Variation application for Sirturo for patients with pulmonary tuberculosis. The Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen) has announced the submission of a Type II Variation application to the European Medicines Agency (EMA) for bedaquiline (Sirturo), indicated as part of a combination therapy for adults and pediatric patients over the age of five with pulmonary tuberculosis (TB) due to multi-drug resistant Mycobacterium tuberculosis. Back in August, a supplemental New Drug Application (sNDA) was also submitted to the FDA for the medication. According to data from the CDC, there was a report of approximately 8,300 cases of TB in 2022, up from 7,874 cases reported in 2021. The center also reports that TB cases in the United States are beginning to return to pre-pandemic levels, following a substantial decline in 2020, likely due to factors associated with ...
- Source: drugdu
- 132
- November 10, 2023
Janssen’s patient programme becomes latest victim of data breach

IBM has announced a data breach of Janssen’s CarePath platform and has started informing affected customers. The Janssen CarePath portal provides patients and healthcare professionals in the US with information regarding insurance coverage, out-of-pocket costs, and prescribing information at no cost to the users. The number of highest grossing Janssen drugs are included in the platform such as Darzalex (daratumumab) and Stelara (ustekinumab) which generated $2.5bn and $3.2bn in US sales in H1 2023, respectively, as per the company’s Q2 2023 financial report. Data breaches at the top pharma companies are nothing new, as companies such as Merck & Co (MSD), Roche, and AstraZeneca have all been hacked in the past. Data breaches cost the companies an average of $5m to remediate, as per IBM’s 2020 data breach report. The Janssen CarePath systems provider, IBM, indicated that the stolen data may have contained information provided as part of the Janssen ...
- Source: drugdu
- 105
- September 11, 2023
Idorsia reacquires aprocitentan rights from Janssen for $343m

Idorsia has decided to reacquire the global rights for the oral endothelin receptor antagonist aprocitentan almost six years after they were sold to Janssen. The news comes after Idorsia announced potential layoffs, and cost-reduction initiatives, including the sale of its Asia Pacific operations, in July due to “lower than anticipated” sales in H1 2023. The reacquisition of aprocitentan is expected to provide a much-needed boost to Idorsia’s profits. GlobalData forecasts aprocitentan to generate $241m in sales in 2029. Idorsia CEO Jean-Paul Clozel said: “Aprocitentan has demonstrated significant and clinically meaningful sustained blood pressure lowering benefits with a good safety profile, particularly suited to the high-risk patient population with resistant hypertension.” Aprocitentan is currently under review with the US Food and Drug Administration (FDA), with a Prescription Drug User Fee Act (PDUFA) set for 19 December. An EU approval application was filled with the European Medicines Agency (EMA) in January. Idorsia ...
- Source: drugdu
- 112
- September 8, 2023
Janssen’s Talvey granted FDA accelerated approval for difficult-to-treat blood cancer

Janssen, a Johnson & Johnson company, has announced that its bispecific antibody has been granted accelerated approval by the US Food and Drug Administration (FDA) for use in certain patients with relapsed or refractory multiple myeloma (RRMM). The authorisation for Talvey (talquetamab-tgvs) specifically applies to adult RRMM patients who have received at least four prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody. Multiple myeloma is a difficult-to-treat blood cancer that affects a type of white blood cell called plasma cells, which are found in the bone marrow. Despite recent advances, Janssen has reported that an unmet need remains for more therapeutic options with different modes of action, including for those treated with prior bispecific or CAR-T cell therapies, to better address the unique characteristics of every patient’s individual needs. Talvey, which is administered as a weekly or bi-weekly subcutaneous injection after an initial step-up phase, ...
- Source: drugdu
- 168
- August 15, 2023
Janssen shares positive phase 3 results for erdafitinib in bladder cancer

The Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen) has shared positive results from a late-stage study of erdafitinib in urothelial carcinoma, the most common type of bladder cancer. Urothelial carcinoma accounts for approximately 90% of bladder cancer cases, and up to 20% of patients diagnosed with metastatic urothelial carcinoma have an FGFR genetic alteration. Despite most urothelial carcinomas being diagnosed at an early stage, rates of recurrence and disease progression are high and a significant proportion of patients who undergo radical surgery will experience disease recurrence. Martin Vogel, EMEA therapeutic area lead oncology, Janssen-Cilag GmbH, said: “Bladder cancer, of which urothelial carcinoma is the most common form, carries a high burden of disease for patients… Patients with advanced urothelial carcinomas, including FGFR-driven tumours who have exhausted standard treatment options, can face a particularly poor prognosis.” Results from an interim analysis of cohort 1 in the phase 3 THOR trial, ...
- Source: drugdu
- 116
- June 10, 2023
Janssen reports decline in 2022 net prices as out-of-pocket costs grow

Nicole DeFeudis https://endpts.com/ Editor While net prices for Janssen’s commercial drugs have declined for the sixth consecutive year, out-of-pocket costs have continued to rise for some patients, according to the company’s latest US Pricing Transparency Report. The company provided $39 billion last year in the form of rebates, discounts and fees to commercial health insurers, pharmacy benefit managers and other intermediaries, it said in the report — a more than $5 billion increase compared to 2021. A majority of that, or $11.2 billion, went to commercial payers and PBMs, while 16% (or $6.2 billion) went to the 340B program, 13% ($5.1 billion) went to Medicare and 10% ($3.8 billion) to Medicaid. In 2021, Janssen provided $6.4 billion to the 340B program, $4.6 billion to Medicare and $3.4 billion to Medicaid. “Unfortunately, the reality for millions of patients is growing affordability and health equity gaps caused by underinsurance and inadequate insurance ...
- Source: drugdu
- 107
- May 29, 2023
Janssen signs $245m deal with Cellular Biomedicine for pair of CAR T-cell therapies

Janssen Biotech, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, has entered into a worldwide collaboration and licensing agreement with Cellular Biomedicine Group (CBMG) for a pair of CAR T-cell therapy candidates. Under the terms of the agreement, Janssen will pay CBMG an upfront fee of $245m, with the Chinese biotech also eligible for certain milestone payments, as well as tiered royalties. In exchange, CBMG will grant Janssen a worldwide licence to develop and commercialise the CAR-T assets, except in Greater China, with the companies set to negotiate an option for the pharma to commercialise the products in the China territory. The investigational CAR-Ts have shown promising early-stage results in patients with relapsed/refractory non-Hodgkin’s lymphoma (NHL), the companies said, with the majority of patients in the studies having diffuse large B-cell lymphoma (DLBCL). DLBCL is the most common type of aggressive lymphoma, accounting for approximately one-third of ...
- Source: drugdu
- 150
- May 6, 2023

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