Janssen Announces U.S. FDA Breakthrough Therapy Designation Granted for Talquetamab for the Treatment of Relapsed or Refractory Multiple Myeloma
June 29, 2022 (RARITAN, N.J.) – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for talquetamab for the treatment of adult patients with relapsed or refractory multiple myeloma, who have previously received at least 4 prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody. Talquetamab is an investigational, off-the-shelf, T-cell redirecting bispecific antibody targeting both GPRC5D, a novel drug target, on multiple myeloma cells and CD3 o...
Source: Johnson and Johnson - June 29, 2022 Category: Pharmaceuticals Tags: Innovation Source Type: news
Janssen Receives Positive CHMP Opinion for IMBRUVICA ® (ibrutinib) in a Fixed-Duration Combination Regimen for Adult Patients with Previously Untreated Chronic Lymphocytic Leukaemia (CLL)
BEERSE, BELGIUM, June 24, 2022 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending approval of a new treatment option with IMBRUVICA® (ibrutinib) in an oral fixed-duration combination with venetoclax (I+V) for adults with previously untreated chronic lymphocytic leukaemia (CLL). Outcomes for patients with CLL have improved in the last decade with the advent of oral therapies that target the underlying disease biology.[1] This provides the opportunity...
Source: Johnson and Johnson - June 24, 2022 Category: Pharmaceuticals Source Type: news
Episode 1: Classifications and Causes of Pulmonary Hypertension Episode 1: Classifications and Causes of Pulmonary Hypertension
Drs Vallerie McLaughlin and Raymond Benza discuss the classifications and causes of pulmonary hypertension.Medscape (Source: Medscape Hiv-Aids Headlines)
Source: Medscape Hiv-Aids Headlines - June 23, 2022 Category: Infectious Diseases Tags: Cardiology InDiscussion Source Type: news
Johnson & Johnson Opens First Satellite Center for Global Health Discovery in Asia Pacific at Duke-NUS to Advance Dengue Research
SINGAPORE, June 21, 2022 – Johnson & Johnson (the Company) today announced the launch of the new J&J Satellite Center for Global Health Discovery (Satellite Center) at Singapore’s Duke-NUS Medical School, jointly established by Duke University and the National University of Singapore (NUS) as a graduate-entry medical school and research powerhouse. As the first of the J&J Centers for Global Health Discovery (J&J Centers) in the Asia-Pacific region, the Satellite Center at Duke-NUS aims to help drive new solutions to address flaviviruses, which disproportionately impact communities across the region, by ...
Source: Johnson and Johnson - June 21, 2022 Category: Pharmaceuticals Source Type: news
Janssen Presents Updated Data at EHA for Teclistamab in Patients with Relapsed or Refractory Multiple Myeloma
June 10, 2022 (VIENNA) – The Janssen Pharmaceutical Companies of Johnson & Johnson announced updated efficacy and safety results from the teclistamab cohort of the Phase 1b TriMM-2 study (NCT04108195). Teclistamab, an investigational, off-the-shelf, T-cell redirecting bispecific antibody targeting B-cell maturation antigen (BCMA) is being studied in combination with DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) in patients with relapsed or refractory multiple myeloma (RRMM) who have received three or more prior lines of therapy.1 Patients in the study, including a high proportion with prior anti-CD38 exposur...
Source: Johnson and Johnson - June 10, 2022 Category: Pharmaceuticals Tags: Innovation Source Type: news
New IMBRUVICA ® (ibrutinib) Data in Fixed-Duration Combination Regimen Presented at EHA 2022 Shows Deep, Durable Response at Three Years in Untreated Chronic Lymphocytic Leukemia
June 10, 2022 (VIENNA) – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced new and updated results from the Phase 2 CAPTIVATE study evaluating IMBRUVICA® (ibrutinib) in combination with venetoclax (I+V) as a potential fixed-duration (FD) treatment in adult patients with previously untreated chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). Updated data from the FD cohort with three years of follow-up shows that I+V continues to demonstrate deep and durable responses and clinically meaningful progression-free survival (PFS) and overall survival (OS) in the first-line tre...
Source: Johnson and Johnson - June 10, 2022 Category: Pharmaceuticals Tags: Innovation Source Type: news
Janssen Presents Updated Results Evaluating First-in-Class GPRC5D Bispecific Antibody Talquetamab in Heavily Pretreated Patients with Multiple Myeloma
June 10, 2022 (VIENNA) – The Janssen Pharmaceutical Companies of Johnson & Johnson announced updated results from the Phase 1 MonumenTAL-1 first-in-human dose-escalation study of talquetamab (NCT03399799), an investigational, off-the-shelf, T cell redirecting bispecific antibody targeting both GPRC5D, a novel multiple myeloma target, and CD3 on T cells.1 Results from the study showed encouraging responses in heavily pretreated patients with relapsed or refractory multiple myeloma (RRMM) who received talquetamab at the recommended subcutaneous Phase 2 dose (RP2D) administered weekly (QW) or every two weeks (Q2W).2 The...
Source: Johnson and Johnson - June 10, 2022 Category: Pharmaceuticals Tags: Innovation Source Type: news
Janssen Presents Initial Results from the Phase 2 RAGNAR Study of BALVERSA ® (erdafitinib) in Patients with Advanced Solid Tumors with FGFR Alterations
CHICAGO, ILLINOIS, June 7, 2022 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced initial results from the pivotal Phase 2 RAGNAR study evaluating the investigational use of BALVERSA® (erdafitinib), a fibroblast growth factor receptor (FGFR) kinase inhibitor, in patients with advanced solid tumors with prespecified FGFR alterations. At a planned interim analysis (IA), responses were observed across a variety of FGFR-driven solid tumors for patients who had exhausted standard treatment options prior to being treated with BALVERSA®.[1] These results will be featured in an oral presentation (...
Source: Johnson and Johnson - June 7, 2022 Category: Pharmaceuticals Tags: Innovation Source Type: news
Updated Data for Janssen ’s Bispecific Teclistamab Suggest Continued Deep and Durable Responses in the Treatment of Patients with Relapsed or Refractory Multiple Myeloma
CHICAGO, ILLINOIS, June 5, 2022 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced updated efficacy and safety results from the teclistamab Phase 1/2 MajesTEC-1 study. Teclistamab is an investigational, off-the-shelf, T-cell redirecting bispecific antibody targeting B-cell maturation antigen (BCMA), which is being studied in patients with relapsed or refractory multiple myeloma (RRMM) who have received three or more prior lines of therapy.1 The data were featured as part of an oral session during the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting. Additional poster presentations f...
Source: Johnson and Johnson - June 5, 2022 Category: Pharmaceuticals Tags: Innovation Source Type: news
Longer-term Data from CARTITUDE-1 Study Demonstrate Continued Deep and Durable Responses to CARVYKTI ™ (ciltacabtagene autoleucel) in Heavily Pretreated Patients with Relapsed or Refractory Multiple Myeloma
CHICAGO, ILLINOIS, June 4, 2022 – – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today updated results from the Phase 1b/2 CARTITUDE-1 study evaluating the efficacy and safety of CARVYKTI™ (ciltacabtagene autoleucel; cilta-cel), a B-cell maturation antigen (BCMA)-directed chimeric antigen receptor T-cell (CAR-T) therapy. The study included patients with relapsed or refractory multiple myeloma (RRMM) who had received >3 lines of therapy including a proteasome inhibitor (PI), an anti-CD38 monoclonal antibody and an immunomodulatory agent (IMiD) or were double refractory to an IMiD and PI a...
Source: Johnson and Johnson - June 4, 2022 Category: Pharmaceuticals Tags: Innovation Source Type: news
Phase 3 SHINE Results Show IMBRUVICA ® (ibrutinib)-Based Combination Regimen Significantly Reduced the Risk of Disease Progression or Death in Older Patients with Newly Diagnosed Mantle Cell Lymphoma
This study is one of the largest clinical trials ever conducted in first-line MCL and the first for a Bruton’s tyrosine kinase inhibitor (BTKi).[1] The data are being presented in an oral session and featured in a press briefing during the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting, and were published in The New England Journal of Medicine today. The data will also be presented as an oral presentation at the 2022 European Hematology Association (EHA) Annual Congress. MCL is a type of aggressive, rare non-Hodgkin lymphoma (NHL) that is incurable and difficult to treat.[2] It commonly affects people o...
Source: Johnson and Johnson - June 3, 2022 Category: Pharmaceuticals Tags: Innovation Source Type: news
New Data Show Patients Treated with First-in-Class TREMFYA ® (guselkumab) Achieve Durable Efficacy Across Joint and Axial Symptoms of Active Psoriatic Arthritis Through Two Years
SPRING HOUSE, PENNSYLVANIA, June 1, 2022 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced new data from Phase 3 studies demonstrating patients treated with TREMFYA® (guselkumab) achieved consistent, long-term efficacy through two years across the domains of active psoriatic arthritis (PsA) – including joint, skin, enthesitis,a dactylitis,b spinal pain and disease severityc endpoints – irrespective of baseline characteristics.1 Further analyses showed TREMFYA also provided patients with sustained improvements in measures of health-related quality of life (HRQoL), including fatigue, pain...
Source: Johnson and Johnson - June 1, 2022 Category: Pharmaceuticals Tags: Innovation Source Type: news
European Commission Grants Conditional Approval of CARVYKTI ® (Ciltacabtagene Autoleucel), Janssen’s First Cell Therapy, for the Treatment of Patients with Relapsed and Refractory Multiple Myeloma
BEERSE, BELGIUM, 26 May 2022 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the European Commission (EC) granted conditional marketing authorisation of CARVYKTI® (ciltacabtagene autoleucel; cilta-cel) for the treatment of adults with relapsed and refractory multiple myeloma (RRMM) who have received at least three prior therapies, including an immunomodulatory agent (IMiD), a proteasome inhibitor (PI) and an anti-CD38 antibody, and have demonstrated disease progression on the last therapy. In December 2017, Janssen Biotech, Inc. (Janssen) entered into an exclusive worldwide license a...
Source: Johnson and Johnson - May 26, 2022 Category: Pharmaceuticals Tags: Innovation Source Type: news
Janssen Presents Study Results Showing Clinical Efficacy for TREMFYA ® (guselkumab) and Long-Term Safety Profile for STELARA® (ustekinumab) for Patients Living with Inflammatory Bowel Disease at Digestive Disease Week® 2022
SPRING HOUSE, PENNSYLVANIA, May 24, 2022 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced new data from the Phase 2 GALAXI 1 clinical trial of TREMFYA® (guselkumab) in adult patients with moderately to severely active Crohn’s disease (CD), and from three separate long-term pooled analyses of adult patients with ulcerative colitis (UC) and CD treated with STELARA® (ustekinumab).1,2,3,4 These data are being presented as oral and poster presentations and are among 29 Janssen abstracts presented during the Digestive Disease Week® (DDW) meeting taking place in person and virtually in San Di...
Source: Johnson and Johnson - May 24, 2022 Category: Pharmaceuticals Source Type: news
AWS' new accelerator cohort will focus on health equity and more digital health briefs
Also: Anumana receives FDA Breakthrough Device Designation for its ECG-based algorithm designed for early detection of pulmonary hypertension, and AI-enabled imaging companies Aidoc and Gleamer partner. (Source: mobihealthnews)
Source: mobihealthnews - May 24, 2022 Category: Information Technology Source Type: news
