Janssen Presents Results from Phase 3 ACIS Study in Patients with Metastatic Castration-Resistant Prostate Cancer Treated with ERLEADA ® (apalutamide) and ZYTIGA® (abiraterone acetate) Combination
RARITAN, N.J., February 8, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today results from the randomized, double-blind, placebo-controlled Phase 3 ACIS study, which met the primary endpoint of radiographic progression-free survival (rPFS) with a 31 percent reduction in the risk of radiographic progression or death in patients with chemotherapy-naïve metastatic castration-resistant prostate cancer (mCRPC) receiving androgen deprivation therapy (ADT). Patients in the trial received either a combination of ERLEADA® and ZYTIGA® plus prednisone (combination arm) or placebo and ZYTIGA® pl...
Source: Johnson and Johnson - February 8, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news
SPRAVATO ® (Esketamine Nasal Spray) Authorised in Europe for the Rapid Reduction of Depressive Symptoms in a Psychiatric Emergency for Patients with Major Depressive Disorder
BEERSE, BELGIUM, February 8, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the European Commission (EC) has authorised the expanded use of SPRAVATO® (esketamine nasal spray), co-administered with oral antidepressant therapy in adults with a moderate to severe episode of MDD, as acute short term treatment, for the rapid reduction of depressive symptoms, which according to clinical judgement constitute a psychiatric emergency.7 “Depression is more than just feeling sad, it’s a debilitating combination of symptoms that are different for each person and can progress to a poin...
Source: Johnson and Johnson - February 8, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news
Johnson & Johnson Announces Submission of Application to the U.S. FDA for Emergency Use Authorization of its Investigational Single-Shot Janssen COVID-19 Vaccine Candidate
NEW BRUNSWICK, N.J., February 4, 2021 – Johnson & Johnson (NYSE: JNJ) (the Company) today announced that Janssen Biotech, Inc., has submitted an application to the U.S. Food and Drug Administration (FDA) requesting Emergency Use Authorization (EUA) for its investigational single-dose Janssen COVID-19 vaccine candidate. The Company’s EUA submission is based on topline efficacy and safety data from the Phase 3 ENSEMBLE clinical trial, demonstrating that the investigational single-dose vaccine met all primary and key secondary endpoints. The Company expects to have product available to ship immediately following autho...
Source: Johnson and Johnson - February 4, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news
REVEAL Lite 2 Risk Calculator Offers Simplified Model to Assess One-Year Mortality Risk Status in Patients with Pulmonary Arterial Hypertension (PAH)
SOUTH SAN FRANCISCO, CA – February 3, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced results from an analysis determining the validity of the Registry to Evaluate Early and Long-Term PAH Disease Management (REVEAL) Lite 2 risk calculator, an abridged version of the REVEAL 2.0 risk calculator, in patients with pulmonary arterial hypertension (PAH), a rapidly progressive disease with no known cure.[1],[2],[3] The analysis showed that REVEAL Lite 2 offers a simplified method of risk assessment using six non-invasive and modifiable variables that may be implemented routinely in daily c...
Source: Johnson and Johnson - February 3, 2021 Category: Pharmaceuticals Tags: Our Company Source Type: news
Janssen to Highlight Robust Solid Tumor Portfolio and Pipeline at 2021 ASCO GU
February 2, 2021 (RARITAN, N.J.) – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today it will highlight the depth of its solid tumor portfolio at the American Society of Clinical Oncology Genitourinary (ASCO GU) Cancers Symposium with 12 data presentations, including three company-sponsored oral presentations from the ERLEADA® (apalutamide) clinical development program. The virtual meeting will take place February 11-13, 2021. “We are committed to the development of innovative therapies for patients with genitourinary cancers for whom there remains a high unmet need,” said Craig Tendler, M...
Source: Johnson and Johnson - February 2, 2021 Category: Pharmaceuticals Tags: Our Company Source Type: news
Johnson & Johnson Announces Single-Shot Janssen COVID-19 Vaccine Candidate Met Primary Endpoints in Interim Analysis of its Phase 3 ENSEMBLE Trial
NEW BRUNSWICK, N.J., January 29, 2021 – Johnson & Johnson (NYSE: JNJ) (the Company) today announced topline efficacy and safety data from the Phase 3
ENSEMBLE
clinical trial, demonstrating that the investigational single-dose COVID-19 vaccine in development at its Janssen Pharmaceutical Companies met all primary and key secondary endpoints. The topline safety and efficacy data are based on 43,783 participants accruing 468 symptomatic cases of COVID-19. The Phase 3 ENSEMBLE study is designed to evaluate the efficacy and safety of the Janssen COVID-19 vaccine candidate in protecting moderate to sever...
Source: Johnson and Johnson - January 29, 2021 Category: Pharmaceuticals Tags: Our Company Source Type: news
Johnson & Johnson Announces Single-Shot Janssen COVID-19 Vaccine Candidate Met Primary Endpoints in Interim Analysis of its Phase 3 ENSEMBLE Trial
NEW BRUNSWICK, N.J., January 29, 2021 – Johnson & Johnson (NYSE: JNJ) (the Company) today announced topline efficacy and safety data from the Phase 3 ENSEMBLE clinical trial, demonstrating that the investigational single-dose COVID-19 vaccine in development at its Janssen Pharmaceutical Companies met all primary and key secondary endpoints. The topline safety and efficacy data are based on 43,783 participants accruing 468 symptomatic cases of COVID-19. The Phase 3 ENSEMBLE study is designed to evaluate the efficacy and safety of the Janssen COVID-19 vaccine candidate in protecting moderate to severe COVID-19, with co...
Source: Johnson and Johnson - January 29, 2021 Category: Pharmaceuticals Tags: Our Company Source Type: news
New Amivantamab Data from CHRYSALIS Study Show Robust Clinical Activity and Durable Responses in Patients with Metastatic or Unresectable Non-Small Cell Lung Cancer and EGFR Exon 20 Insertion Mutations
January 28, 2021 (RARITAN, N.J.) – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced new data from the Phase 1 CHRYSALIS study, which evaluated amivantamab in patients with metastatic or unresectable non-small cell lung cancer (NSCLC) and epidermal growth factor receptor (EGFR) exon 20 insertion mutations whose disease progressed on or after platinum-based chemotherapy.1 These data were presented for the first time in an oral presentation at the International Association for the Study of Lung Cancer’s (IASLC) 2020 World Conference on Lung Cancer (WCLC) Singapore. The key findings showed robu...
Source: Johnson and Johnson - January 29, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news
Janssen Announces U.S. FDA Approval of CABENUVA (rilpivirine and cabotegravir), the First Long-Acting Regimen for the Treatment of HIV
TITUSVILLE, N.J., January 21, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the U.S. Food and Drug Administration (FDA) has approved CABENUVA (consisting of Janssen’s rilpivirine and ViiV Healthcare’s cabotegravir), the first and only once-monthly, long-acting regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults. The novel regimen was co-developed as part of a collaboration with ViiV Healthcare and builds on Janssen’s 25-year commitment to make HIV history. In the U.S., ViiV Healthcare is the marketing authorization holder for CABENUVA.C...
Source: Johnson and Johnson - January 22, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news
DARZALEX FASPRO ® (daratumumab and hyaluronidase-fihj) Becomes the First FDA-Approved Treatment for Patients with Newly Diagnosed Light Chain (AL) Amyloidosis
January 15, 2021 (HORSHAM, Pa.) – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the U.S. Food and Drug Administration (FDA) approval of DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj), a subcutaneous formulation of daratumumab, in combination with bortezomib, cyclophosphamide and dexamethasone (D-VCd) for the treatment of adult patients with newly diagnosed light chain (AL) amyloidosis.[1] DARZALEX FASPRO® is the first and only FDA-approved treatment for patients with this blood cell disorder that is associated with the production of an abnormal protein, which leads to the deterior...
Source: Johnson and Johnson - January 16, 2021 Category: Pharmaceuticals Tags: Our Company Source Type: news
Inhaled Treprostinil Beneficial in Pulmonary Hypertension
Exercise capacity improved, clinical worsening reduced for patients with pulmonary HTN due to interstitial lung disease (Source: Pulmonary Medicine News - Doctors Lounge)
Source: Pulmonary Medicine News - Doctors Lounge - January 14, 2021 Category: Respiratory Medicine Tags: Cardiology, Pharmacy, Pulmonology, Journal, Source Type: news
Inhaled Treprostinil Beneficial in Pulmonary Hypertension
THURSDAY, Jan. 14, 2021 -- Inhaled treprostinil improves exercise capacity in patients with pulmonary hypertension due to interstitial lung disease, according to a study published online Jan. 13 in the New England Journal of Medicine.
Aaron Waxman,... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - January 14, 2021 Category: Pharmaceuticals Source Type: news
Janssen to Highlight Commitment to Lung Cancer Science and Innovation with Eight Data Presentations at the International Association for the Study of Lung Cancer ’s 2020 World Conference on Lung Cancer
January 12, 2021 (RARITAN, N.J.) – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that eight company-sponsored presentations, including two oral presentations, will be featured at the International Association for the Study of Lung Cancer’s (IASLC) 2020 World Conference on Lung Cancer (WCLC) Singapore taking place virtually January 28-31, 2021. The presentations include updated data from the Phase 1 CHRYSALIS study (NCT02609776) evaluating amivantamab in patients with NSCLC and EGFR exon 20 insertion mutations and two studies that characterize the high unmet need and lack of standard of c...
Source: Johnson and Johnson - January 13, 2021 Category: Pharmaceuticals Tags: Our Company Source Type: news
Janssen Initiates Rolling Submission of a Biologics License Application to U.S. FDA for BCMA CAR-T Therapy Ciltacabtagene Autoleucel (cilta-cel) for the Treatment of Relapsed and/or Refractory Multiple Myeloma
December 21, 2020 (RARITAN, N.J.) – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the initiation of a rolling submission of its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for ciltacabtagene autoleucel (cilta-cel), an investigational B-cell maturation antigen (BCMA)-directed chimeric antigen receptor T cell (CAR-T) therapy, for the treatment of adults with relapsed and/or refractory multiple myeloma.“We are committed to innovation in cell therapy and advancing the science of multiple myeloma to improve patients’ lives,” said Peter Lebowitz, M.D....
Source: Johnson and Johnson - December 21, 2020 Category: Pharmaceuticals Tags: Innovation Source Type: news
New Data Demonstrate Long-Term Benefit of IMBRUVICA ® (ibrutinib) as First-Line Treatment for High-Risk Chronic Lymphocytic Leukemia
This study highlighted the need for cytogenetic/molecular testing before CIT treatment, consistent with clinical treatment guidelines.[8],[9]Real-World Prognostic Biomarker Testing, Treatment Patterns, And Dosing Among Patients With CLL/SLL From the informCLL™ Prospective Observational Registry (Abstract #547)An oral presentation on Monday, December 7, will feature results from the informCLL™ real-world prospective observational registry assessing treatment patterns in the era of novel agents.4 Key Study Findings:· The most common index treatment was IMBRUVICA®; the majority of patients treated with IMBRUVICA® remai...
Source: Johnson and Johnson - December 6, 2020 Category: Pharmaceuticals Tags: Innovation Source Type: news
