TREMFYA ® (guselkumab) Demonstrates a Differentiated Binding Mechanism from Risankizumab in In Vitro Studies
SPRING HOUSE, PENNSYLVANIA, March 3, 2023 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced additional results from in vitro MODIF-Y studies, which continue to support a hypothesis that not all IL-23 inhibitors are the same by demonstrating a differentiated binding mechanism for TREMFYA® (guselkumab) from risankizumab. Findings show that guselkumab is able to dose-dependently bind to CD64+a myeloid cells,1 the predominant source of IL-23-driven inflammation in the gut.2,b Data comprise one of Janssen’s 22 oral and poster presentations at the 18th Congress of the European Crohn’s and Col...
Source: Johnson and Johnson - March 3, 2023 Category: Pharmaceuticals Tags: Latest News Source Type: news
Janssen Launches Health Equity Campaign in Partnership with Award-Winning Radio Host D.L. Hughley to Raise Awareness About Multiple Myeloma Among Black Communities
HORSHAM, P.A., March 2, 2023 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the launch of That’s My Word™ to raise awareness of and help to drive better health outcomes for multiple myeloma among at-risk populations. A national campaign bringing together trusted voices among Black communities, including those at risk of multiple myeloma, care partners, healthcare professionals, advocacy groups and award-winning radio host and comedian D.L. Hughley, That’s My Word™ aims to be a source of both information and hope by sharing resources specifically for Black patients and their care p...
Source: Johnson and Johnson - March 2, 2023 Category: Pharmaceuticals Tags: Latest News Source Type: news
Janssen Submits New Drug Application to the U.S. Food and Drug Administration Seeking Approval of Niraparib and Abiraterone Acetate Dual-Action Tablet, Plus Prednisone, as a First-Line Targeted Treatment for Patients with Metastatic Castration-Resistant Prostate Cancer with BRCA Gene Mutations
RARITAN, N.J., February 28, 2023 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval of niraparib in combination with abiraterone acetate, in the form of a dual-action tablet (DAT), plus prednisone, for the treatment of patients with BRCA-positive metastatic castration-resistant prostate cancer (mCRPC). If approved, this will be the first DAT formulation available in the U.S. to patients with mCRPC with BRCA mutations, which are a type of homologous recombination repair (HRR) gene alt...
Source: Johnson and Johnson - March 1, 2023 Category: Pharmaceuticals Tags: Latest News Source Type: news
Janssen Receives Positive CHMP Opinion for AKEEGA ® (Niraparib and Abiraterone Acetate Dual Action Tablet) Plus Prednisone or Prednisolone for the Treatment of Adult Patients with BRCA1/2 Gene-Mutated Metastatic Castration Resistant Prostate Cancer
BEERSE, Belgium, 24 February 2023 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended marketing authorisation for AKEEGA® (niraparib and AA), in the form of a DAT, given with P or prednisolone, for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC) and BRCA1/2 mutations (germline and/or somatic) in whom chemotherapy is not clinically indicated.[1]Niraparib is a highly selective poly adenosine diphosphate-ribose polymerase (PARP) inhibi...
Source: Johnson and Johnson - February 27, 2023 Category: Pharmaceuticals Tags: Latest News Source Type: news
Janssen Presents Updated Data Demonstrating Improved Outcomes from the Use of Niraparib in Combination with Abiraterone Acetate Plus Prednisone as a First-Line Therapy in Patients with BRCA-Positive Metastatic Castration-Resistant Prostate Cancer
SAN FRANCISCO, February 16, 2023 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced updated results from the Phase 3 MAGNITUDE study evaluating the investigational use of niraparib, a highly selective poly (ADP-ribose) polymerase (PARP) inhibitor, in combination with abiraterone acetate plus prednisone (AAP) in patients with metastatic castration-resistant prostate cancer (mCRPC) with or without specific homologous recombination repair (HRR) gene alterations, including BRCA mutations. Results will be featured today in a Rapid Abstract Session (Abstract #170) at the American Society of Clinica...
Source: Johnson and Johnson - February 16, 2023 Category: Pharmaceuticals Tags: Latest News Source Type: news
Janssen Data at ASCO GU Support Ambition to Transform Treatment of Prostate and Bladder Cancer Through Precision Medicine and Early Intervention
RARITAN, N.J., February 13, 2023 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced plans to present more than 20 abstracts featuring seven oncology therapies from its robust portfolio and pipeline at the annual American Society of Clinical Oncology (ASCO) Genitourinary (GU) Cancers Symposium, taking place in San Francisco on February 16-18. Building on more than a decade of leadership in the development of medicines for people diagnosed with GU cancers, Janssen will present data demonstrating its ambition to advance patient-centered treatment through precision medicine, real-world evidence a...
Source: Johnson and Johnson - February 13, 2023 Category: Pharmaceuticals Tags: Latest News Source Type: news
Meconium: It Can Cause a Sticky Mess
Discussion
During fetal life from approximately 12-13 weeks gestation, meconium accumulates in the small bowel and migrates to the large bowel and rectum by ~20 weeks gestation. Meconium is a combination of bile, mucous, desquamated intestinal cells, bowel secretions, dessicated swallowed amniotic fluid and lanugo. It is sterile before birth and once produced is odorless with a blackish green (sometimes brown or yellow) color, and tarry or sticky quality. Defecation does not occur during fetal life unless the fetus is significantly stressed. Normal meconium passage after birth occurs within 24-48 hours of life (more often ...
Source: PediatricEducation.org - February 13, 2023 Category: Pediatrics Authors: Pediatric Education Tags: Uncategorized Source Type: news
Janssen Reports Positive Topline Phase 2 Results for Nipocalimab in Pregnant Individuals at High Risk for Severe Hemolytic Disease of the Fetus and Newborn (HDFN)
SPRING HOUSE, PENNSYLVANIA, February 6, 2023 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced positive topline results from the proof-of-concept Phase 2 open-label UNITY clinical trial for the treatment of pregnant adults at high risk for severe hemolytic disease of the fetus and newborn (HDFN). HDFN is a serious and rare condition which can cause life-threatening anemia in the fetus. It occurs when the blood types of a pregnant individual and their fetus are incompatible.1 The trial met the primary endpoint, with the majority of pregnant patients who received nipocalimab achieving a live b...
Source: Johnson and Johnson - February 8, 2023 Category: Pharmaceuticals Tags: Latest News Source Type: news
Janssen Announces Unblinding of Phase 3 CARTITUDE-4 Study of CARVYKTI ® (cilta-cel) as Primary Endpoint Met in Treatment of Patients with Relapsed and Refractory Multiple Myeloma
RARITAN, New Jersey, January 27, 2023 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the Phase 3 CARTITUDE-4 study evaluating CARVYKTI® (ciltacabtagene autoleucel; cilta-cel) versus pomalidomide, bortezomib, and dexamethasone (PVd) or daratumumab, pomalidomide, and dexamethasone (DPd) for the treatment of patients with relapsed and lenalidomide-refractory multiple myeloma met its primary endpoint of significant improvement in progression-free survival (PFS) at the first pre-specified interim analysis. As a result of meeting the primary endpoint, the Independent Data Monitoring Commi...
Source: Johnson and Johnson - January 27, 2023 Category: Pharmaceuticals Tags: Latest News Source Type: news
Janssen and Global Partners to Discontinue Phase 3 Mosaico HIV Vaccine Clinical Trial
LEIDEN, THE NETHERLANDS, (January 18, 2023) – The Janssen Pharmaceutical Companies of Johnson & Johnson, together with a consortium of global partners, today announced the results of an independent, scheduled data review of the Phase 3 Mosaico study (also known as HPX3002/HVTN706) of Janssen’s investigational HIV vaccine regimen. The study’s independent Data and Safety Monitoring Board (DSMB) determined that the regimen was not effective in preventing HIV infection compared to placebo among study participants. No safety issues with the vaccine regimen were identified.In light of the DSMB’s determination, the Mo...
Source: Johnson and Johnson - January 18, 2023 Category: Pharmaceuticals Tags: Latest News Source Type: news
Real-World Study Shows Patients Treated with IMBRUVICA ® (ibrutinib) Were Less Likely to Initiate a Next-Line Treatment than Patients on Acalabrutinib in First-line Chronic Lymphocytic Leukemia
NEW ORLEANS, December 12, 2022 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced results of a real-world study showing that patients with chronic lymphocytic leukemia (CLL) treated with first-line acalabrutinib monotherapy were 89 percent more likely to start a next-line treatment than those treated with IMBRUVICA® (ibrutinib).[1] These data suggest the potential that first-line treatment with IMBRUVICA® in routine practice may provide patients with the ability to use once-daily, all-oral IMBRUVICA® as a monotherapy treatment for a longer period without the need to start the next line of ...
Source: Johnson and Johnson - December 12, 2022 Category: Pharmaceuticals Tags: Latest News Source Type: news
Janssen Presents Efficacy and Subgroup Analyses from MAIA Study Showing Long-Term Results of DARZALEX ® (daratumumab)-based Regimen in Newly Diagnosed, Transplant-Ineligible Multiple Myeloma
NEW ORLEANS, December 12, 2022 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced new analyses from the Phase 3 MAIA study of DARZALEX® (daratumumab) in combination with lenalidomide and dexamethasone (D-Rd), evaluating progression-free survival (PFS), minimal residual disease (MRD) negativity and overall response rate (ORR) at a median follow-up of 64.5 months, and overall survival (OS) at a median follow-up of 73.6 months in newly diagnosed, transplant-ineligible (TIE) patients with multiple myeloma, regardless of patients’ age and across clinically important subgroups, as well as health...
Source: Johnson and Johnson - December 12, 2022 Category: Pharmaceuticals Tags: Latest News Source Type: news
Janssen Presents First Data from MajesTEC-2 Trial of TECVAYLI ™ (teclistamab-cqyv) in Combination with DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) and Lenalidomide in Relapsed or Refractory Multiple Myeloma
NEW ORLEANS, December 10, 2022 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today new results from a cohort of the Phase 1b MajesTEC-2 study of TECVAYLI™ (teclistamab-cqyv), a first-in-class, BCMAxCD3 bispecific T-cell engager antibody, in combination with DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) and lenalidomide. According to the results, the immune-based triplet therapy regimen had a manageable safety profile with no unexpected safety signals observed. A very good partial response (VGPR) or better was achieved by 90.3 percent of patients with relapsed or refractory multiple ...
Source: Johnson and Johnson - December 10, 2022 Category: Pharmaceuticals Tags: Latest News Source Type: news
Janssen Presents New Data for Talquetamab, a First-in-Class GPRC5DxCD3 Bispecific Antibody, Suggesting Durable Responses in Patients with Heavily Pretreated Multiple Myeloma
NEW ORLEANS, December 10, 2022 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today updated results from the Phase 1/2 MonumenTAL-1 study of talquetamab, an investigational, off-the-shelf (ready to use), bispecific T-cell engager antibody. Talquetamab targets both GPRC5D, a novel target on multiple myeloma cells, and CD3 on T cells, activating the body’s immune system to fight this blood cancer.[1] Results from the study suggest patients with relapsed or refractory multiple myeloma who received a median of five prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agen...
Source: Johnson and Johnson - December 10, 2022 Category: Pharmaceuticals Tags: Latest News Source Type: news
New Results from the Phase 3 GLOW Study of Fixed-Duration Treatment with IMBRUVICA ® (ibrutinib) Plus Venetoclax Demonstrate Robust Efficacy and Sustained Response in Older, Unfit Patients with Previously Untreated Chronic Lymphocytic Leukemia
NEW ORLEANS, December 10, 2022 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced new four-year follow-up results from the Phase 3 GLOW study (Abstract #93), which showed investigational, fixed-duration treatment with IMBRUVICA® + venetoclax (I+V) reduced the risk of progression or death by 79 percent among older and/or unfit patients with previously untreated chronic lymphocytic leukemia (CLL) compared to patients treated with chemoimmunotherapy.[i] These results were highlighted in an oral presentation during the 2022 American Society of Hematology (ASH) Annual Meeting.1CLL is the most com...
Source: Johnson and Johnson - December 10, 2022 Category: Pharmaceuticals Tags: Latest News Source Type: news
