Johnson & Johnson Single-Shot COVID-19 Vaccine Candidate Unanimously Recommended for Emergency Use Authorization by U.S. FDA Advisory Committee
NEW BRUNSWICK, N.J., February 26, 2021 – Johnson & Johnson (NYSE: JNJ) (the Company) today announced that the U.S. Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) unanimously voted to recommend Emergency Use Authorization (EUA) for the Company’s single-shot COVID-19 vaccine candidate for adults 18 and older, developed by the Janssen Pharmaceutical Companies of Johnson & Johnson. The vote was based on a totality of scientific evidence provided by the Company, including efficacy and safety data from the Phase 3 ENSEMBLE trial. “We are e...
Source: Johnson and Johnson - February 26, 2021 Category: Pharmaceuticals Tags: Our Company Source Type: news

Janssen Announces Submission of Supplemental New Drug Application to U.S. FDA by ViiV Healthcare for Expanded Use of CABENUVA (rilpivirine and cabotegravir) as an HIV Treatment for Use Every Two Months
TITUSVILLE, N.J., February 24, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that a supplemental New Drug Application (sNDA) has been submitted to the U.S. Food and Drug Administration (FDA) by ViiV Healthcare for the expanded use of CABENUVA (consisting of Janssen’s long-acting rilpivirine and ViiV Healthcare’s cabotegravir). The sNDA seeks to expand the CABENUVA label to include administration every two months for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in virologically suppressed adults (HIV-1 RNA less than 50 copies per mL) on a sta...
Source: Johnson and Johnson - February 24, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news

Johnson & Johnson Announces Submission to World Health Organization for Emergency Use Listing of Investigational Single-Shot Janssen COVID-19 Vaccine Candidate
NEW BRUNSWICK, N.J., February 19, 2021– Johnson & Johnson (NYSE: JNJ) (the Company) announced that Janssen-Cilag International N.V. has submitted for Emergency Use Listing (EUL) to the World Health Organization (WHO) for the investigational single-dose Janssen COVID-19 vaccine candidate. The data package delivered today includes interim efficacy and safety results from the Phase 3 ENSEMBLE clinical trial. The Company’s rolling submission of clinical data to WHO is now complete.“Our filing with the World Health Organization marks another important step in our effort to combat COVID-19 and also in our u...
Source: Johnson and Johnson - February 19, 2021 Category: Pharmaceuticals Tags: Our Company Source Type: news

Johnson & Johnson Announces Submission of European Conditional Marketing Authorisation Application to the EMA for its Investigational Single-Shot Janssen COVID-19 Vaccine Candidate
NEW BRUNSWICK, N.J., February 16, 2021 – Johnson & Johnson (NYSE: JNJ) (the Company) today announced that Janssen-Cilag International N.V., has submitted a conditional Marketing Authorisation Application (cMAA) to the European Medicines Agency (EMA) seeking authorisation for its investigational single-dose Janssen COVID-19 vaccine candidate. The submission is based on topline efficacy and safety data from the Phase 3 ENSEMBLE clinical trial.“Throughout Europe, there remains an urgent need for additional COVID-19 vaccines, and today’s submission is a significant step forward in ensuring the European Un...
Source: Johnson and Johnson - February 16, 2021 Category: Pharmaceuticals Tags: Our Company Source Type: news

Janssen Announces Treatment with ERLEADA ® (apalutamide) Significantly Improved Overall Survival in Patients with Metastatic Castration-Sensitive Prostate Cancer
RARITAN, N.J., February 8, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today results from the final analysis of the Phase 3 TITAN study, which demonstrated the continued statistically significant benefit of the addition of ERLEADA® (apalutamide) to androgen deprivation therapy (ADT) in overall survival (OS) in patients with metastatic castration-sensitive prostate cancer (mCSPC), regardless of extent of disease, when compared to placebo plus ADT.[1] Results will be featured in an oral presentation at the American Society of Clinical Oncology’s Genitourinary (ASCO GU) Cance...
Source: Johnson and Johnson - February 8, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news

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 a...
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 prog...
Source: Johnson and Johnson - February 8, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news

Johnson & Johnson to Participate in the Cowen 41st Annual Health Care Virtual Conference
New Brunswick, NJ (February 5th, 2021) -- Johnson & Johnson (NYSE: JNJ) will participate in the Cowen 41st Annual Health Care Virtual Conference on Wednesday, March 3rd, Ashley McEvoy, Executive Vice President, Worldwide Chairman, Medical Devices will represent the Company in a session scheduled at 10:20 a.m. (Eastern Time). This conference call will be available to investors and other interested parties by visit the Johnson & Johnson website at www.investor.jnj.com. A webcast and podcast replay will be available approximately 48 hours after the live webcast. ### (Source: Johnson and Johnson)
Source: Johnson and Johnson - February 5, 2021 Category: Pharmaceuticals Tags: Our Company 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 followi...
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...
Source: Johnson and Johnson - February 3, 2021 Category: Pharmaceuticals Tags: Our Company Source Type: news

Johnson & Johnson to Participate in the Raymond James 42nd Annual Institutional Investors Conference
New Brunswick, NJ (February 3, 2021) -- Johnson & Johnson (NYSE: JNJ) will participate in the Raymond James 42nd Annual Institutional Investors Conference on Tuesday, March 2nd. Joseph J. Wolk, Executive Vice President and Chief Financial Officer will represent the Company in a session scheduled at 9:10 a.m. (Eastern Time). This webcast will be available to investors and other interested parties by accessing the Johnson & Johnson website at www.investor.jnj.com.A webcast replay will be available approximately 24-hrs after the live webcast.### (Source: Johnson and Johnson)
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 C...
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 severe 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 sho...
Source: Johnson and Johnson - January 29, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news

Johnson & Johnson to Participate in the Citi's 2021 Healthcare Services, Medtech, Tools, & HCIT Virtual Conference
New Brunswick, NJ (January 27, 2021) -- Johnson & Johnson (NYSE: JNJ) will participate in the Citi's 2021 Healthcare Services, Medtech, Tools, & HCIT Virtual Conference on Thursday, February 25th. Jennifer Taubert, Executive Vice President, Worldwide Chairman Pharmaceuticals will represent the Company in a session scheduled at 10:45 a.m. (Eastern Time). This webcast will be available to investors and other interested parties by accessing the Johnson & Johnson website at www.investor.jnj.com.A webcast and podcast replay will be available approximately 48 hours after the live webcast.### (Source: Johnson and Johnson)
Source: Johnson and Johnson - January 27, 2021 Category: Pharmaceuticals Tags: Our Company Source Type: news

Johnson & Johnson Reports 2020 Fourth-Quarter and Full Year Results
New Brunswick, N.J. (January 26, 2021) – Johnson & Johnson (NYSE: JNJ) today announced results for fourth-quarter and full year 2020. “Our notable full year performance reflects the continued confidence from patients, physicians, customers and consumers in our life-enhancing products and medicines, particularly throughout the COVID-19 pandemic,” said Alex Gorsky, Chairman and Chief Executive Officer. “I’m incredibly proud of our Johnson & Johnson teams around the world for going above and beyond to meet stakeholder needs. These efforts, and our commitment to families around the world a...
Source: Johnson and Johnson - January 26, 2021 Category: Pharmaceuticals Tags: Our Company 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 holde...
Source: Johnson and Johnson - January 22, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news

Auris Health Announces Publication of Results from BENEFIT Study of MONARCH ® Platform in CHEST
This study was conducted using strict definitions for diagnostic yield. In previous studies, variations in the definition of yield led to overestimation of a successful bronchoscopy. Given this strict trial design, the diagnostic yield of 74.1% is promising, and we hope this sets the stage for future multicenter trials,” said Dr. Silvestri, Hillenbrand Professor of Thoracic Oncology at Medical University. “We are thrilled to be making a meaningful impact on the diagnosis of lung conditions, particularly in patients with small and difficult to reach nodules that may progress to something more serious,” sai...
Source: Johnson and Johnson - January 21, 2021 Category: Pharmaceuticals Tags: Our Company Source Type: news

DePuy Synthes Receives 510(k) FDA Clearance for VELYS ™ Robotic-Assisted Solution Designed for Use with the ATTUNE® Total Knee System
PALM BEACH GARDENS, FL., January 19, 2021 – Today, The Johnson & Johnson Medical Devices Companies* announced that DePuy Synthes** has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the VELYS™ Robotic-Assisted Solution designed for use with the ATTUNE® Total Knee System and its cleared indications for use. It will become part of the broader VELYS Digital Surgery Platform of connected technologies. With a growing and aging patient population, demand for joint replacement surgery is increasing. But across the industry, data shows up to 20% of knee replacement patients aren&...
Source: Johnson and Johnson - January 19, 2021 Category: Pharmaceuticals Tags: Our Company 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 th...
Source: Johnson and Johnson - January 16, 2021 Category: Pharmaceuticals Tags: Our Company Source Type: news

Johnson & Johnson Statement on Political Contributions
New Brunswick, NJ (January 14, 2021) – Johnson & Johnson strongly condemns the tragic and violent events that occurred at the United States Capitol. These actions sought to undermine the very fabric of our democracy and have led to violence and further divisiveness within our nation. As a healthcare Company with a 130-year history of innovations that improve the health of humanity, and one currently fighting to end the COVID-19 pandemic, the wellbeing of all people is our top priority.While we support balanced giving on both sides of the aisle, and do so with domestic and global health initiatives in mind, we und...
Source: Johnson and Johnson - January 14, 2021 Category: Pharmaceuticals Tags: Our Company Source Type: news

Johnson & Johnson COVID-19 Vaccine Candidate Interim Phase 1/2a Data Published in New England Journal of Medicine
January 13, 2021 -- Interim Phase 1/2a data were published today in the New England Journal of Medicine demonstrating that the Company’s single-dose investigational COVID-19 vaccine candidate (JNJ-78436735) – being developed by the Janssen Pharmaceutical Companies of Johnson & Johnson – provided an immune response that lasted for at least 71 days, the duration of time measured in this study in participants aged 18-55 years. A preview of part of these interim data was posted on medRxiv in September 2020.The Phase 1/2a interim analysis showed that the Company’s COVID-19 vaccine candidate induced a...
Source: Johnson and Johnson - January 13, 2021 Category: Pharmaceuticals Tags: Our Company 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 stand...
Source: Johnson and Johnson - January 13, 2021 Category: Pharmaceuticals Tags: Our Company Source Type: news

Statement by Alex Gorsky, Johnson & Johnson Chairman and CEO
New Brunswick, NJ (January 6, 2021) – As an American, as a colleague to tens of thousands of Johnson & Johnson employees in the country, and as a U.S. military veteran who served overseas to protect our democracy, I’m devasted by this assault on what our country has stood for since its founding: free, fair and peaceful elections. Now is the time to stand shoulder-to-shoulder in unity – not face-to-face in conflict – and to chart our path to a better and healthier future. (Source: Johnson and Johnson)
Source: Johnson and Johnson - January 7, 2021 Category: Pharmaceuticals Tags: Our Company Source Type: news

Johnson & Johnson Announces Quarterly Dividend for First Quarter 2021
New Brunswick, NJ (January 4, 2021) – Johnson & Johnson today announced that its Board of Directors has declared a cash dividend for the first quarter of 2021 of $1.01 per share on the company’s common stock. The dividend is payable on March 9, 2021 to shareholders of record at the close of business on February 23, 2021. The ex-dividend date is February 22, 2021.About Johnson & JohnsonAt Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. That’s why for more than 130 years, we have aimed to keep people well at every age and e...
Source: Johnson and Johnson - January 4, 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 Pete...
Source: Johnson and Johnson - December 21, 2020 Category: Pharmaceuticals Tags: Innovation Source Type: news

Johnson & Johnson to Host Investor Conference Call on Fourth-Quarter Results
New Brunswick, NJ (December 18th, 2020) - Johnson & Johnson (NYSE: JNJ) will host a conference call for investors at 8:30 a.m. (Eastern Time) on Tuesday, January 26th to review fourth-quarter results. Alex Gorsky, Chairman and Chief Executive Officer; Joseph J. Wolk, Executive Vice President and Chief Financial Officer and Christopher DelOrefice, Vice President, Investor Relations will host the call. Investors and other interested parties can access the webcast/conference call in the following ways:The webcast and presentation material are accessible at Johnson & Johnson’s website www.investor.jnj.com. A repl...
Source: Johnson and Johnson - December 18, 2020 Category: Pharmaceuticals Tags: Our Company Source Type: news

Johnson & Johnson to Participate in the 39th Annual J.P. Morgan Healthcare Conference
New Brunswick, NJ (December 14, 2020) -- Johnson & Johnson (NYSE: JNJ) will participate virtually in the 39th Annual J.P. Morgan Healthcare Conference on Monday, January 11th. Alex Gorsky, Chairman and Chief Executive Officer and Joseph J. Wolk, Executive Vice President and Chief Financial Officer will represent the Company in a session scheduled at 2:00 p.m. (Eastern Time). This webcast will be available to investors and other interested parties by accessing the Johnson & Johnson website at www.investor.jnj.com.A webcast replay will be available approximately 24-hrs after the live webcast. (Source: Johnson and Johnson)
Source: Johnson and Johnson - December 14, 2020 Category: Pharmaceuticals Tags: Our Company 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 ...
Source: Johnson and Johnson - December 6, 2020 Category: Pharmaceuticals Tags: Innovation Source Type: news

Janssen Presents First Data from the Phase 1 Study of the GPRC5DxCD3 Bispecific Talquetamab in Patients with Relapsed or Refractory Multiple Myeloma
December 5, 2020 (RARITAN, N.J.) – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today initial data for the Phase 1 first-in-human dose escalation study of talquetamab (JNJ-64407564) for the treatment of relapsed or refractory multiple myeloma (NCT03399799). Talquetamab is a first-in-class, and the only investigational bispecific antibody that targets both GPRC5D, a novel multiple myeloma target, and CD3 on T-cells. Initial results for both the subcutaneous (SC) and intravenous (IV) formulations show encouraging clinical activity against the GPRC5D target, which is highly expressed on multip...
Source: Johnson and Johnson - December 5, 2020 Category: Pharmaceuticals Tags: Innovation Source Type: news

Updated Results from the Phase 1 Study of the BCMAxCD3 Bispecific Teclistamab Show Preliminary Efficacy in Patients with Heavily Pretreated Relapsed or Refractory Multiple Myeloma
This study evaluated the ability of teclistamab to induce cytotoxicity and T-cell activation.About TeclistamabTeclistamab is an investigational bispecific antibody targeting both BCMA and CD3. BCMA, B-cell maturation antigen, is expressed at high levels on multiple myeloma cells.[3],[4],[5],[6],[7] Teclistamab redirects CD3-positive T-cells to BCMA-expressing myeloma cells to induce cytotoxicity of the targeted cells.5,6 Results from preclinical studies demonstrate that teclistamab kills myeloma cell lines and bone marrow-derived myeloma cells from heavily pretreated patients.6 Teclistamab is currently being evaluated in a...
Source: Johnson and Johnson - December 5, 2020 Category: Pharmaceuticals Tags: Innovation Source Type: news

Early, Deep, Durable Responses of Ciltacabtagene Autoleucel (cilta-cel) Observed in Phase 1b/2 CARTITUDE-1 Study Show Potential of BCMA CAR-T in Treatment of Heavily Pretreated Patients with Multiple Myeloma
December 5, 2020 (RARITAN, N.J.) – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today longer-term results from the combined Phase 1b/2 CARTITUDE-1 study (NCT03548207) evaluating the efficacy and safety of ciltacabtagene autoleucel (cilta-cel), an investigational B cell maturation antigen (BCMA)-directed chimeric antigen receptor T cell (CAR-T) therapy, for the treatment of patients with relapsed and/or refractory multiple myeloma. These data, presented as an oral presentation at the American Society of Hematology (ASH) 2020 Annual Meeting (Abstract #177), continued to demonstrate a very hig...
Source: Johnson and Johnson - December 5, 2020 Category: Pharmaceuticals Tags: Innovation Source Type: news

Disease-Free Survival Data from CAPTIVATE Study Demonstrate Benefit of IMBRUVICA ® (ibrutinib)-Based Regimen as Fixed Duration, First-Line Treatment for Patients with Chronic Lymphocytic Leukemia
December 5, 2020 (RARITAN, N.J.) – New data from the Phase 2 CAPTIVATE study were presented today during an oral session at the 2020 American Society of Hematology (ASH) Annual Meeting (Abstract #123). The study evaluated the efficacy and safety of IMBRUVICA® (ibrutinib) plus venetoclax in the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) and showed that, after achieving undetectable minimal residual disease (uMRD) in both the blood and bone marrow with the IMBRUVICA® combination regimen, the one-year disease-free survival (DFS) of patients randomized ...
Source: Johnson and Johnson - December 5, 2020 Category: Pharmaceuticals Tags: Innovation Source Type: news

Janssen Submits Application to U.S. FDA Seeking Approval of Amivantamab for the Treatment of Patients with Metastatic Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations
RARITAN, N.J., December 3, 2020 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) seeking approval of amivantamab for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy. The application marks the first-ever regulatory submission for the treatment of patients with NSCLC with EGFR exon 20 insertion mutations.[1] The Company...
Source: Johnson and Johnson - December 3, 2020 Category: Pharmaceuticals Tags: Innovation Source Type: news

Johnson & Johnson Names Dr. Nadja West, retired United States Army lieutenant general and former United States Army Surgeon General to its Board of Directors
New Brunswick, NJ (December 3, 2020) – Johnson & Johnson announced today that Dr. Nadja West, retired United States Army lieutenant general and former United States Army Surgeon General has been appointed to its Board of Directors.“I am pleased to welcome Dr. Nadja West to Johnson & Johnson’s Board of Directors,” said Alex Gorsky, Chairman and Chief Executive Officer. “Nadja is an accomplished healthcare leader with a strong commitment to public service and she brings an impressive and unique combination of business and leadership expertise to Johnson & Johnson. I look forward to N...
Source: Johnson and Johnson - December 3, 2020 Category: Pharmaceuticals Tags: Our Company Source Type: news

Janssen Acquires Rights to Novel Gene Therapy, Pioneering Treatment Solutions for Late-Stage Age-Related Macular Degeneration
RARITAN, NJ, December 2, 2020 – Janssen Pharmaceuticals, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, today announced the acquisition of rights to Hemera Biosciences, LLC’s investigational gene therapy HMR59, administered as a one-time, outpatient, intravitreal injection to help preserve vision in patients with geographic atrophy, a late-stage and severe form of age-related macular degeneration (AMD). Financial terms of the transaction with Hemera Biosciences, a privately-owned biotechnology company, are not being disclosed. Patients with AMD often have low levels of CD59, a prote...
Source: Johnson and Johnson - December 2, 2020 Category: Pharmaceuticals Tags: Innovation Source Type: news

Johnson & Johnson to Address Racial and Social Injustice Through Platform that Aims to Eliminate Health Inequities for People of Color
NEW BRUNSWICK, N.J., November 17, 2020 – Johnson & Johnson announced today $100 million in commitments and collaborations over the next five years to invest in and promote health equity solutions for Black people and other communities of color in the United States. Society has been significantly impacted by systemic racism, the COVID-19 pandemic, and the economic decline throughout this year, which have all spotlighted healthcare inequities. “There is an urgent need to take on the inequities rooted in systemic racism that threaten health in communities of color across the United States,” said Alex Gor...
Source: Johnson and Johnson - November 17, 2020 Category: Pharmaceuticals Tags: Our Company Source Type: news

Johnson & Johnson Initiates Second Global Phase 3 Clinical Trial of its Janssen COVID-19 Vaccine Candidate
November 15, 2020 -- The Phase 3 ENSEMBLE study of the single-dose regimen of JNJ-78436735, the investigational vaccine candidate for the prevention of COVID-19 being developed by the Janssen Pharmaceutical Companies of Johnson & Johnson, continues to enroll and vaccinate study participants. ENSEMBLE is proceeding to enroll up to 60,000 participants worldwide.In addition to the single-dose regimen ENSEMBLE study, Janssen has now initiated the two-dose regimen ENSEMBLE 2 trial. ENSEMBLE 2 is a complementary, planned, pivotal, large-scale, multi-country Phase 3 trial that will study the safety and efficacy of a two-dose ...
Source: Johnson and Johnson - November 16, 2020 Category: Pharmaceuticals Tags: Our Company Source Type: news

Johnson & Johnson and U.S. Department of Health & Human Services Expand Agreement to Support Next Phase of COVID-19 Vaccine Candidate Research and Development
NEW BRUNSWICK, N.J., November 14, 2020 – Johnson & Johnson (the Company) announced the expansion to the partnership between its Janssen Pharmaceutical Companies (Janssen) and the Biomedical Advanced Research and Development Authority (BARDA), which is part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services for the ongoing development of Janssen’s investigational COVID-19 vaccine candidate.Under the amendment, Janssen will commit approximately $604 million and BARDA will commit approximately $454 million to support the ongoing Pha...
Source: Johnson and Johnson - November 14, 2020 Category: Pharmaceuticals Tags: Our Company Source Type: news

Late-Breaking 12-Month Data of Investigational RPGR Gene Therapy Shows Statistically Significant and Continued Vision Improvement in Patients with X-Linked Retinitis Pigmentosa
RARITAN, N.J., November 13, 2020 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today new 12-month data from the ongoing Phase 1/2 trial (NCT03252847) of its investigational gene therapy for inherited retinal disease X-linked retinitis pigmentosa (XLRP). The data showed that low and intermediate doses were well-tolerated and continued to demonstrate statistically significant sustained or increased vision improvement across multiple metrics (mean sensitivity, volumetric and pointwise) and modalities (full-field static perimetry and microperimetry). Data on the novel adeno-associated virus re...
Source: Johnson and Johnson - November 13, 2020 Category: Pharmaceuticals Tags: Innovation Source Type: news

New XARELTO ® (rivaroxaban) Peripheral Artery Disease (PAD) Data from EXPLORER Clinical Research Program to be Unveiled at American Heart Association (AHA) Scientific Sessions 2020
RARITAN, N.J., November 9, 2020 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that 10 data presentations will be shared at the virtual American Heart Association (AHA) Scientific Sessions 2020 from November 13-17. Most notably, four new sub-analyses of XARELTO® (rivaroxaban) from the landmark VOYAGER PAD trial, part of the EXPLORER global cardiovascular research program, will be presented, including two live, featured science oral presentations. “We're pleased VOYAGER PAD was selected to be front and center once again at a major medical congress, as there's an urgent need f...
Source: Johnson and Johnson - November 9, 2020 Category: Pharmaceuticals Tags: Innovation Source Type: news

Johnson & Johnson to Host Virtual Medical Devices Update
NEW BRUNSWICK, NJ – November 6, 2020 – Johnson & Johnson (NYSE: JNJ) will hold a virtual Medical Devices Update for the investment community on Thursday, November 19, 2020, in which leadership will focus on the Company’s differentiated and competitive platforms across digital surgery and provide franchise and innovation highlights across the Johnson & Johnson Medical Devices Companies.“We look forward to providing an update on the strength of our Medical Devices business and how we are positioning ourselves for long-term success through meaningful innovation that will continue to make a diff...
Source: Johnson and Johnson - November 6, 2020 Category: Pharmaceuticals Tags: Our Company Source Type: news

Janssen Headlines American Society of Hematology Annual Meeting With More Than 35 Presentations Highlighting Deep, Diverse Oncology Pipeline and Portfolio
RARITAN, N.J., November 5, 2020 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today more than 35 company-sponsored studies, including 10 oral presentations, will be featured at the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition taking place virtually December 5-8, 2020.In multiple myeloma, highlights include Phase 1b/2 results for the B-cell maturation antigen (BCMA)-targeted chimeric antigen receptor T-cell (CAR-T) therapy ciltacabtagene autoleucel (cilta-cel); new and updated data for the anti-CD38 monoclonal antibody DARZALEX® (daratumumab) and the subcutane...
Source: Johnson and Johnson - November 5, 2020 Category: Pharmaceuticals Tags: Innovation Source Type: news

Janssen Submits Application to U.S. FDA for New Indication to Expand Use of XARELTO ® (rivaroxaban) in Patients with Peripheral Artery Disease
RARITAN, NJ, October 26, 2020 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today it has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for a new indication to expand the use of XARELTO® (rivaroxaban) in patients with peripheral artery disease (PAD). If approved, this new indication for the XARELTO® vascular dose (2.5 mg twice daily plus aspirin 75-100 mg once daily) would include reducing the risk of major thrombotic vascular events such as heart attack, stroke and amputation in patients after recent lower-extremity revasculariz...
Source: Johnson and Johnson - October 26, 2020 Category: Pharmaceuticals Tags: Innovation Source Type: news

Johnson & Johnson Prepares to Resume Phase 3 ENSEMBLE Trial of its Janssen COVID-19 Vaccine Candidate in the U.S.
Discussions with other regulators around the world to resume the clinical trial program are progressing. After a thorough evaluation of a serious medical event experienced by one study participant, no clear cause has been identified. There are many possible factors that could have caused the event. Based on the information gathered to date and the input of independent experts, the Company has found no evidence that the vaccine candidate caused the event.At Johnson & Johnson, there is no greater priority than the health and safety of the people we serve every day around the world. Our primary goal is to ensure the safet...
Source: Johnson and Johnson - October 23, 2020 Category: Pharmaceuticals Source Type: news

Johnson & Johnson to Participate in the Credit Suisse 29th Annual Virtual Healthcare Conference
New Brunswick, NJ (October 15, 2020) -- Johnson & Johnson (NYSE: JNJ) will participate in the Credit Suisse 29th Annual Virtual Healthcare Conference on Wednesday, November 11th. Joaquin Duato, Vice Chairman of the Executive Committee and Thibaut Mongon, Executive Vice President, Worldwide Chairman Consumer Health will represent the Company in a session scheduled at 11:45 a.m. (Eastern Time). This webcast will be available to investors and other interested parties by accessing the Johnson & Johnson website at www.investor.jnj.com.A webcast replay will be available approximately 48-hours after the live webcast. (Sou...
Source: Johnson and Johnson - October 15, 2020 Category: Pharmaceuticals Tags: Our Company Source Type: news

Johnson & Johnson Reports 2020 Third-Quarter Results
New Brunswick, N.J. (October 13, 2020) – Johnson & Johnson (NYSE: JNJ) today announced results for third-quarter 2020. “Our third-quarter results reflect solid performance and positive trends across Johnson & Johnson, powered by better-than-expected procedure recovery in Medical Devices, growth in Consumer Health, and continued strength in Pharmaceuticals,” said Alex Gorsky, Chairman and Chief Executive Officer. “I am proud of the relentless passion and Credo-led commitment to patients and customers that our colleagues around the world continue to demonstrate as we boldly fight the COVID-19 ...
Source: Johnson and Johnson - October 13, 2020 Category: Pharmaceuticals Tags: Our Company Source Type: news

Statement on Opioid Resolution
October 13, 2020 – Johnson & Johnson and its U.S.-based Janssen Pharmaceutical Companies disclosed that the Company will contribute up to an additional $1 billion to an all-in settlement amount that would resolve opioid lawsuits filed and future claims by states, cities, counties and tribal governments. This amount represents an increase to the $4 billion agreement in principle announced by a committee of State Attorneys General on October 21, 2019, for a total of $5 billion. Additional terms and conditions are still being finalized. This additional amount results from continued negotiations and is intended to ma...
Source: Johnson and Johnson - October 13, 2020 Category: Pharmaceuticals Source Type: news

Johnson & Johnson Temporarily Pauses All Dosing in Our Janssen COVID-19 Vaccine Candidate Clinical Trials
At Johnson & Johnson, there is no greater priority than the safety and well being of the people we serve every day around the world. We are committed to providing transparent updates throughout the clinical development process of our vaccine candidate, in compliance with regulatory standards and our own high ethical and scientific principles.We have temporarily paused further dosing in all our COVID-19 vaccine candidate clinical trials, including the Phase 3 ENSEMBLE trial, due to an unexplained illness in a study participant. Following our guidelines, the participant’s illness is being reviewed and evaluated by ...
Source: Johnson and Johnson - October 13, 2020 Category: Pharmaceuticals Source Type: news

Champions of Science: Breaking the Stigma of Mental Illness
NEW BRUNSWICK, NJ – October 8, 2020 – As the COVID-19 pandemic continues to increase stress, fear, and uncertainty worldwide, there has never been a more critical time to champion mental healthcare. Join us virtually for the Champions of Science: Breaking the Stigma of Mental Illness webcast, open to the public, on Thursday, October 15, 2020, at 12:00 p.m. ET via Johnson & Johnson’s page on LinkedIn. During the event, we will speak to scientists, advocates, and global experts who are working tirelessly to ensure stigma does not stand in the way of people living with mental illness seeking the care and...
Source: Johnson and Johnson - October 8, 2020 Category: Pharmaceuticals Tags: Innovation Source Type: news