Underscores the urgent need for improved diagnosis and clinical management of psoriasis in patients with skin of colour and enhanced treatment standards
TORONTO, Jan. 23, 2025 /CNW/ - Johnson & Johnson (NYSE: JNJ) is proud to announce a Canadian first: the publication of a consensus statement titled, "Optimizing the management of psoriasis in patients with skin of colour: a Canadian Delphi consensus." This groundbreaking consensus underscores the urgent need for improved diagnosis and clinical management of psoriasis in patients with skin of colour, offering expert recommendations to address the gaps in care for this patient population.
Following U.S. FDA Priority Review, approval is based on data demonstrating SPRAVATO® alone met its primary endpoint at 4 weeks and led to rapid and superior improvement in depressive symptoms compared to placebo as early as 24 hours1
SPRAVATO® alone showed a rapid and superior improvement vs. placebo in the Montgomery-Asberg Depression Rating Scale (MADRS) total score, with numerical improvements across all 10 MADRS items seen at day 28 in a post-hoc analysis2
Monotherapy data adds to well-established clinical efficacy and real-world safety profile of SPRAVATO®
Phase 3 MARIPOSA-2 study showed RYBREVANT® in combination with carboplatin and pemetrexed significantly improved progression-free survival compared to carboplatin and pemetrexed alone.1
TORONTO, Jan. 16, 2025 /CNW/ - Johnson & Johnson (NYSE: JNJ) announced today that Health Canada has issued a Notice of Compliance (NOC) for RYBREVANT® (amivantamab for injection) in combination with carboplatin and pemetrexed (platinum-based chemotherapy) for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) Exon 19 deletions or Exon 21 L858R substitution mutations, whose disease has progressed on or after treatment with osimertinib.1
Application accepted for U.S. FDA Real-Time Oncology Review (RTOR) based on Phase 2b SunRISe-1 study showing highest single-agent complete response rate of 83.5 percent1
RARITAN, N.J., Jan. 15, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) announced it has initiated the submission of an original New Drug Application with the U.S. Food and Drug Administration (FDA) for TAR-200 for the treatment of patients with Bacillus Calmette-Guérin (BCG)-unresponsive high-risk non-muscle-invasive bladder cancer (HR-NMIBC) with carcinoma in situ (CIS), with or without papillary tumors. This submission is being reviewed by the FDA through the Real-Time Oncology Review (RTOR) program, which allows the FDA to review data before the complete application is formally submitted and helps ensure treatments are available for patients as soon as possible.
Building on decades of the Company's Alzheimer's research, two differentiated investigational therapies aim to slow pathological tau in distinct populations
Fast Track designations reinforce J&J's commitment to Alzheimer's disease development and the potential of its precision approach
TITUSVILLE, N.J., Jan. 8, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to posdinemab, a phosphorylated tau-directed monoclonal antibody (mAb) being investigated to treat patients with early Alzheimer's disease (AD) in the Phase 2b "AuTonomy" study. The internally discovered mAb has shown the potential in targeting disease-associated phosphorylated tau in cerebrospinal fluid (CSF) from treated AD patients, and in blocking the development and spread of tau aggregates in non-clinical models of disease.
Median overall survival improvement expected to exceed one year
First and only regimen with a survival benefit over current standard of care in first-line treatment of EGFR-mutated lung cancer
RARITAN, N.J., Jan. 7, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE:JNJ) today announced positive topline results for the gold standard endpoint in cancer treatment of overall survival (OS) from the Phase 3 MARIPOSA study, evaluating RYBREVANT® (amivantamab-vmjw) plus LAZCLUZE™ (lazertinib) as a first-line therapy for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions (ex19del) or L858R substitution mutations. The chemotherapy-free combination regimen met the final pre-specified secondary endpoint of OS and demonstrated clinically meaningful and statistically significant improvement in OS versus the current standard of care osimertinib. Improvement in median OS is expected to exceed one year.
89 percent of patients evaluable for MRD assessment were MRD negative, with the majority reaching MRD negativity in less than 2 months
Results add to the overall survival (OS) benefits recently presented, as the first and only cell therapy to significantly extend OS versus standard therapies in multiple myeloma
SAN DIEGO, Dec. 9, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE:JNJ) announced today new results from the Phase 3 CARTITUDE-4 study that show a single infusion of CARVYKTI® (ciltacabtagene autoleucel; cilta-cel) significantly increased minimal residual disease (MRD) negativity rates (10-5) in patients with relapsed or refractory multiple myeloma (RRMM) who were lenalidomide-refractory and had received one to three prior lines of therapy, including a proteasome inhibitor (PI), compared to standard therapies of pomalidomide, bortezomib and dexamethasone (PVd) or daratumumab, pomalidomide and dexamethasone (DPd).1 MRD is a prognostic marker of prolonged survival outcomes for patients with multiple myeloma. These results add to the overall survival (OS) benefits recently presented at the International Myeloma Society meeting earlier this year, as the first and only cell therapy to significantly extend OS versus standard therapies for patients with multiple myeloma.1 Findings were featured in an oral presentation at the 2024 American Society of Hematology (ASH) Annual Meeting (Abstract #1032).1
Abstracts presented at ASH 2024 provide insight into the patient experience given the unpredictable nature of wAIHA, a rare autoantibody disease, and the uncertainty of current treatment approaches used to manage the condition
There are no FDA-approved therapies indicated for wAIHA, and patients living with this condition need targeted treatment options with a proven safety and efficacy profile
Johnson & Johnson is evaluating nipocalimab for the potential treatment of wAIHA in the Phase 2/3 ENERGY study, which is expected to read out in 2025
New analysis from Phase 3 CEPHEUS study demonstrates 85 percent of patients who achieved MRD negativity (10-6) with DARZALEX FASPRO® were progression free at 4.5 years
Subgroup analysis from Phase 3 AURIGA study show higher rates of MRD-negative conversion in patient populations disproportionately impacted by multiple myeloma
SAN DIEGO, Dec. 8, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today announced data highlighting that DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj)-based regimens improve overall and sustained minimal residual disease (MRD) negativity rates and progression-free survival (PFS) in patients with newly diagnosed multiple myeloma (NDMM), regardless of transplant status.1,2 These findings were demonstrated in an expanded MRD analysis of the Phase 3 CEPHEUS study (Abstract #362) and a post hoc analysis of clinically relevant subgroups in the Phase 3 AURIGA study (Abstract #675), which were both featured as oral presentations at the 2024 American Society of Hematology (ASH) Annual Meeting.
100 percent of evaluable patients for minimal residual disease (MRD) testing achieved MRD negativity in MajesTEC-5 as induction therapy and MajesTEC-4 as maintenance therapy
SAN DIEGO, Dec. 8, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE:JNJ) today announced new frontline data featuring TECVAYLI® (teclistamab-cqyv) from two investigational studies in patients with newly diagnosed multiple myeloma (NDMM) in induction and maintenance settings. The MajesTEC-5 (Abstract #493) and MajesTEC-4 (Abstract #494) studies establish the potential of TECVAYLI® for use in newly diagnosed patients, with promising efficacy and a tolerable safety profile. These data were highlighted as oral presentations at the 2024 American Society of Hematology (ASH) Annual Meeting.1,2
First and only subcutaneous anti-CD38 therapy demonstrating potential to prevent end-organ damage, and extend progression-free survival and overall survival based on findings from Phase 3 AQUILA study
SAN DIEGO, Dec. 8, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today announced data from the Phase 3 AQUILA study showing that DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) significantly delayed progression from high-risk smoldering multiple myeloma (SMM) to active multiple myeloma (MM) and extended overall survival compared to the current standard of care of active monitoring.1 The data were presented for the first time as an oral presentation at the 2024 American Society of Hematology (ASH) Annual Meeting (Abstract #773), as part of the Press Program and were selected for the Best of ASH session.
Applications filed for TREMFYA® to treat children with moderate to severe plaque psoriasis and active juvenile psoriatic arthritis
SPRING HOUSE, Pa., Dec. 2, 2024 /PRNewswire/ -- Johnson & Johnson today announced the submission of two supplemental Biologics License Applications (sBLAs) to the U.S. Food and Drug Administration (FDA) seeking approval of TREMFYA® (guselkumab) for the treatment of children 6 years and older with moderate-to-severe plaque psoriasis (PsO) and children 5 years of age and older with active juvenile psoriatic arthritis (jPsA).a
Following recent U.S. FDA approval of TREMFYA® for adults with moderately to severely active ulcerative colitis (UC), this submission underscores its potential to be the only IL-23 inhibitor that offers choice of subcutaneous or intravenous induction in UC
Submission is supported by the Phase 3 ASTRO study, which achieved the primary endpoint of clinical remission at Week 12 and met all secondary endpoints in adults with moderately to severely active UC
SPRING HOUSE, Pa., Nov. 22, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking approval of a subcutaneous (SC) induction regimen of TREMFYA® (guselkumab) for the treatment of adults with moderately to severely active UC. The filing is supported by data from the Phase 3 ASTRO study of TREMFYA® SC induction therapy in adults with UC and builds upon the recent U.S. approval of TREMFYA® in this indication.
Authorization is based on results from the Phase 3 CARTITUDE-4 (MMY3002) study, which showed treatment with CARVYKTI® reduced the risk of disease progression or death by 74 per cent compared to standard of care.1
TORONTO, Nov. 21, 2024 /CNW/ - Johnson & Johnson (NYSE: JNJ) announced today that Health Canada has issued a Notice of Compliance (NOC) for CARVYKTI® (ciltacabtagene autoleucel) for the treatment of adult patients with multiple myeloma who have received one to three prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent, and who are refractory to lenalidomide.1 With this approval, CARVYKTI® becomes the first and only B-cell Maturation Antigen (BCMA)-targeted therapy approved for the treatment of patients with multiple myeloma as early as second line.
More than 90 presentations of clinical trial and real-world data highlight potentially practice-changing evidence and commitment to pioneer the next wave of therapies for patients with hematologic malignancies
RARITAN, N.J., Nov. 19, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE:JNJ) announced today more than 90 abstracts featuring data from the Company's differentiated blood cancer portfolio and pipeline will be presented at the 66th American Society of Hematology (ASH) Annual Meeting in San Diego from December 7-10. Clinical trial and real-world data will highlight the Company's broad and expanding portfolio of hematologic therapies, deepening its leadership in novel approaches to treat multiple myeloma as well as myeloid and B-cell malignancies. Six additional abstracts focus on the Company's commitment and patient insights in warm autoimmune hemolytic anemia (wAIHA), a rare autoantibody-driven disease, and fetal and neonatal alloimmune thrombocytopenia (FNAIT), an alloimmune disorder of pregnancy.
Icotrokinra (JNJ-2113), a first-in-class investigational targeted oral peptide that selectively blocks the IL-23 receptor, met its co-primary endpoints in patients with moderate to severe plaque psoriasis
74% of patients achieved clear or almost clear skin (IGA 0/1) at week 24
Comprehensive results are being prepared for presentation at upcoming medical congresses
SPRING HOUSE, Pa., Nov. 18, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today announced positive topline results from ICONIC-LEADa, a pivotal Phase 3 investigational study of icotrokinra (JNJ-2113), the first targeted oral peptide that selectively blocks the IL-23 receptor, in adults and adolescents 12 years of age and older with moderate to severe plaque psoriasis (PsO). The Phase 3 study met its co-primary endpoints of Psoriasis Area and Severity Index (PASI) 90b and Investigator's Global Assessment (IGA) of 0/1c response at week 16 and response rates continued to improve through week 24.1
Adults with moderately-to-severely active Sjögren's disease who received investigational FcRn blocker nipocalimab had improvements in disease activity scores at 24 weeks with accompanying significant reductions in IgG and autoantibody levels
Nipocalimab was granted U.S. FDA Breakthrough Therapy Designation for the treatment of adults living with moderate-to-severe Sjögren's disease based on results from the Phase 2 DAHLIAS study
WASHINGTON, Nov. 14, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today announced results from additional analyses of the Phase 2 DAHLIAS study highlighting improvement in key measures of disease activity and significant IgG reduction by over 77% following treatment with investigational nipocalimab in adult patients with moderate-to-severe Sjögren's disease (SjD). These data were included in a plenary session presentation (Abstract #2527) and two posters (Abstracts #1427 and #2294) and are among the Company's 43 oral and poster presentations at the American College of Rheumatology (ACR) Convergence 2024.
The Breakthrough Therapy Designation (BTD) for investigational nipocalimab in Sjögren's disease, a prevalent autoantibody disease with no approved advanced therapies, is supported by results from the Phase 2 DAHLIAS study
A greater than 70 percent relative improvement in systemic disease activity at Week 24 was demonstrated in study participants on average who received nipocalimab 15 mg/kg compared to participants who received placebo
Nipocalimab was granted BTD in hemolytic disease of the fetus and newborn earlier this year, making this the second time Johnson & Johnson's nipocalimab has received this designation
If approved, DARZALEX FASPRO® will become the first treatment option for patients with smoldering multiple myeloma at high-risk of developing multiple myeloma, offering a novel approach to treat before the onset of active disease and the occurrence of end organ damage
RARITAN, N.J., Nov. 8, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE:JNJ) today announced the submission of regulatory applications to the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) seeking approval of a new indication for DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) in the U.S. and DARZALEX® subcutaneous (SC) formulation in the European Union (EU). The applications are supported by data from the ongoing Phase 3 AQUILA study (NCT03301220) of DARZALEX FASPRO® as monotherapy for the treatment of adult patients with high-risk smoldering multiple myeloma.1
New data for investigational nipocalimab in Sjögren's Disease (SjD) and new research on the impact of TREMFYA® (guselkumab) in psoriatic arthritis (PsA) will be highlighted across three oral sessions and a plenary session
Results from the Phase 2 DAHLIAS study of nipocalimab in SjD show nipocalimab met the primary endpoint with a reduction in ClinESSDAI score from baseline and other key efficacy endpoints at Week 24 compared with placebo, presented in a plenary session
Results from the PsABIOnd observational study highlight the patient-reported impact in psoriatic arthritis (PsA) disease burden following treatment with TREMFYA®, presented as an oral presentation
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