Johnson & Johnson Medical Announces Strategic Partnership With Aussie Startup Navbit To Bring Smartphone-Inspired Tech To Hip Replacement Surgery
Sydney, Australia, June 24, 2021 – DePuy Synthes in Australia, a business unit of Johnson & Johnson Medical Pty Ltd, today announced it has entered into an exclusive agreement with Australian start-up Navbit to introduce the Navbit Sprint into operating theatres across the country. The Australian-made innovation is a compact, single use medical device designed to assist surgeons in placing and aligning the acetabular cup, a component that is placed into the hip socket during joint replacement surgery. It uses smartphone-like GPS technology to provide real-time feedback to the surgeon on the position of the cup th...
Source: Johnson and Johnson - June 23, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news

Janssen Submits New Drug Application to U.S. FDA for XARELTO ® (rivaroxaban) to Help Prevent and Treat Blood Clots in Pediatric Patients
RARITAN, NJ, June 23, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the use of XARELTO® (rivaroxaban) in pediatric patients. The NDA seeks two pediatric indications: treatment of venous thromboembolism (VTE, or blood clots) and reduction in the risk of recurrent VTE in patients aged birth to less than 18 years of age after at least five days of initial parenteral anticoagulant treatment; and thromboprophylaxis (prevention of blood clots) in patients aged 2 years and older with co...
Source: Johnson and Johnson - June 23, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news

Ethicon Expands Advanced Biopolar Energy Portfolio With Launch Of Enseal X1 Curved Jaw Tissue Sealer
CINCINNATI, OH – June 21, 2021 -- Ethicon*, part of the Johnson & Johnson Medical Devices Companies,** today announced the launch of the ENSEAL X1 Curved Jaw Tissue Sealer, a new advanced bipolar energy device that increases procedural efficiency[1] and provided stronger sealing[2] and better access to more tissue than LigaSure™ Maryland.[3] The device is indicated for colorectal, gynecological, bariatric surgery and thoracic procedures. The ENSEAL X1 Curved Jaw is the first of several new advanced laparoscopic bipolar devices the company plans to launch in the coming months as it expands its extensive ener...
Source: Johnson and Johnson - June 21, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news

New Phase 3 Study Results Show IMBRUVICA ® (ibrutinib)-Based Combination Regimen as an All-Oral Fixed-Duration Treatment Demonstrated Superior Progression-Free Survival in Adult Patients with Previously Untreated Chronic Lymphocytic Leukemia
Raritan, N.J., June 12, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced primary results from the pivotal Phase 3 GLOW study (NCT03462719) evaluating fixed-duration IMBRUVICA® plus venetoclax (I+V) compared to chlorambucil plus obinutuzumab (Clb+O) for first-line treatment of elderly or unfit patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). The study demonstrated superior progression-free survival (PFS) of a once-daily, all-oral, fixed-duration regimen of I+V versus Clb+O as first-line treatment of CLL; the study also showed improved duratio...
Source: Johnson and Johnson - June 12, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news

Janssen Announces Results from Phase 3 MAIA Study Showing Significant Overall Survival Benefits for Treatment with DARZALEX ® (daratumumab) in Patients with Newly Diagnosed Multiple Myeloma Who are Transplant Ineligible
Raritan, N.J., June 12, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced overall survival (OS) results from the Phase 3 MAIA (NCT02252172) study showing the addition of DARZALEX® (daratumumab) to lenalidomide and dexamethasone (D-Rd) resulted in a statistically significant survival benefit over lenalidomide and dexamethasone (Rd) alone in patients with newly diagnosed multiple myeloma (NDMM) who were ineligible for autologous stem cell transplant (ASCT) and were treated to progression.[1] These data were featured in the European Hematology Association (EHA) 2021 Virtual Press Briefin...
Source: Johnson and Johnson - June 12, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news

Johnson & Johnson Statement on Supply of its Single-shot COVID-19 Vaccine
New Brunswick, N.J., June 11, 2021 – Johnson & Johnson confirms the United States Food & Drug Administration (FDA) has authorized two batches of drug substance, manufactured at the Emergent BioSolutions, Inc. Bayview facility, under the Emergency Use Authorization (EUA) for its single-shot COVID-19 vaccine. “Since establishing our COVID-19 vaccine program, Johnson & Johnson has committed to producing safe, high-quality vaccines in order to bring health and hope to people everywhere,” said Kathy Wengel, Executive Vice President and Chief Global Supply Chain Officer, Johnson & Johnson. &ldqu...
Source: Johnson and Johnson - June 11, 2021 Category: Pharmaceuticals Tags: Our Company Source Type: news

Johnson & Johnson Announces Six Global Winners for the 2021 Women in STEM2D Scholar Awards
New Brunswick, N.J., June 11, 2021 – Johnson & Johnson announced today its prestigious Women in STEM2D (WiSTEM2D) Scholar Award recipients, marking the fifth year since the Awards’ inception. The program recognizes one scholar in each STEM2D discipline: Science, Technology, Engineering, Math, Manufacturing and Design, and provides each recipient with $150,000 in research funding and three years of mentorship from Johnson & Johnson. Six diverse, international female recipients were selected out of a competitive global applicant pool that garnered more than 650 applications from 40 countries. Launched in ...
Source: Johnson and Johnson - June 11, 2021 Category: Pharmaceuticals Tags: Our Company Source Type: news

Johnson & Johnson Statement on FDA Approval of Shelf Life Extension for Company ’s COVID-19 Vaccine
NEW BRUNSWICK, N.J., June 10, 2021 -- We are pleased to confirm the U.S. Food & Drug Administration (FDA) has authorized an extension of the shelf life for the Johnson & Johnson single-shot COVID-19 vaccine from 3 months to 4.5 months. The decision is based on data from ongoing stability assessment studies, which have demonstrated that the vaccine is stable at 4.5 months when refrigerated at temperatures of 36 – 46 degrees Fahrenheit (2 – 8 degrees Celsius). Expiration dates will be updated on www.vaxcheck.jnj. Vaccine providers should visit www.vaxcheck.jnj to confirm the latest expiration dates of our...
Source: Johnson and Johnson - June 10, 2021 Category: Pharmaceuticals Tags: Our Company Source Type: news

Johnson & Johnson to Host Investor Conference Call on Second-Quarter Results
New Brunswick, NJ (June 9th, 2021) - Johnson & Johnson (NYSE: JNJ) will host a conference call for investors at 8:30 a.m. (Eastern Time) on Wednesday, July 21st to review second-quarter results. Joseph J. Wolk, Executive Vice President and Chief Financial Officer and Christopher DelOrefice, Vice President, Investor Relations will host the call. The question and answer portion of the call will also include Alex Gorsky, Chairman and Chief Executive Officer.Investors and other interested parties can access the webcast/conference call in the following ways:The webcast and presentation material are accessible at Johnson &am...
Source: Johnson and Johnson - June 9, 2021 Category: Pharmaceuticals Tags: Our Company Source Type: news

Johnson & Johnson Releases 2020 Health for Humanity Report Highlighting Performance and Progress on Environmental, Social and Governance Priorities
NEW BRUNSWICK, N.J., June 9, 2021 – Johnson & Johnson (NYSE: JNJ) today published the 2020 Health for Humanity Report (Report), which serves as the Company’s annual disclosure on environmental, social and governance (ESG) performance and illustrates progress toward fulfilling its corporate purpose to change the trajectory of health for humanity. The Report documents the Company’s performance and provides information on how the Company generates long-term social, environmental and economic value for all stakeholders; provides an accounting of the final year of progress against the Johnson & Johnson...
Source: Johnson and Johnson - June 9, 2021 Category: Pharmaceuticals Tags: Our Company Source Type: news

Statement on the SAGE Recommendation Regarding the Johnson & Johnson Ebola Vaccine Regimen
New Brunswick, NJ (June 4, 2021) – Johnson & Johnson welcomes the recommendation by the Strategic Advisory Group of Experts (SAGE) on Immunization for the World Health Organization (WHO) in support of the use of Johnson & Johnson’s two-dose Ebola vaccine regimen, Zabdeno® (Ad26.ZEBOV) and Mvabea® (MVA-BN-Filo), both during outbreaks for individuals at some risk of Ebola exposure and preventively, before outbreaks, for national and international first responders.This is an important milestone for our Ebola vaccine and our mission to help prevent and control Ebola outbreaks. It follows Marketing A...
Source: Johnson and Johnson - June 4, 2021 Category: Pharmaceuticals Tags: Our Company Source Type: news

New Phase 3b Psoriatic Arthritis (PsA) Data Show First-in-Class TREMFYA ® (guselkumab) Achieved Robust Joint Symptom Improvement and Complete Skin Clearance in Patients with Inadequate Response to Tumor Necrosis Factor Inhibition (TNFi-IR)
SPRING HOUSE, PENNSYLVANIA, June 2, 2021 – Today the Janssen Pharmaceutical Companies of Johnson & Johnson announced new efficacy and safety data for first-in-class TREMFYA® (guselkumab), including data from the first study evaluating a selective IL-23 inhibitor in adult patients with active PsA, all of whom had demonstrated inadequate response or intolerance to TNFi.1 In the COSMOS Phase 3b study, significantly higher proportions of patients treated with TREMFYA showed joint symptom improvement and complete skin clearance versus placebo at week 24 in this true TNFi-IRa patient population, which is often more...
Source: Johnson and Johnson - June 2, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news

Janssen Highlights Commitment to Advancing Transformative Innovations in Oncology with Scientific Updates from Deep, Diverse Pipeline and Portfolio at ASCO and EHA Virtual Scientific Programs
June 1, 2021 (RARITAN, N.J.) – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that more than 30 company-sponsored studies, including six oral presentations, will be featured during the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting, June 4-8. Janssen presentations will include new data and updates for both approved and investigational therapeutics that are being studied for the treatment of various solid tumors and blood cancers. Immediately following ASCO, additional data will be featured during the European Hematology Association (EHA) Virtual Congress, June 9-17. A ...
Source: Johnson and Johnson - June 1, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news

Janssen Announces U.S. FDA Breakthrough Therapy Designation Granted for Teclistamab for the Treatment of Relapsed or Refractory Multiple Myeloma
June 1, 2021 (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 teclistamab in the treatment of relapsed or refractory multiple myeloma. This distinction for teclistamab, an off-the-shelf, T-cell redirecting, bispecific antibody targeting both B-cell maturation antigen (BCMA) and CD3 receptors, follows a PRIME (PRIority MEdicines) designation from the European Medicines Agency (EMA) received earlier this year. Today’s BTD marks the 11th received by Janssen’s ...
Source: Johnson and Johnson - June 1, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news

Janssen Reports New Data for BCMA CAR-T, Cilta-Cel, Showing Deep and Durable Responses in Patients with Relapsed or Refractory Multiple Myeloma
June 1, 2021 (RARITAN, N.J.) – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced new data for ciltacabtagene autoleucel (cilta-cel), an investigational B-cell maturation antigen (BCMA)-directed CAR-T therapy, demonstrated sustained efficacy and durable responses in heavily pretreated patients with relapsed/refractory multiple myeloma (RRMM). Updated results from the Phase 1b/2 CARTITUDE-1 study (n=97) with a longer-term follow-up at a median of 18 months showed an overall response rate (ORR) of 98 percent, with 80 percent of patients achieving a stringent complete response (sCR), highlight...
Source: Johnson and Johnson - June 1, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news

Updated Data Demonstrate Significant Improvement in Hematologic Complete Response with DARZALEX FASPRO ® (daratumumab and hyaluronidase-fihj) in Patients with Newly Diagnosed Light Chain (AL) Amyloidosis
RARITAN, N.J., May 26, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced updated results from the Phase 3 ANDROMEDA study, which evaluated DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) for the treatment of patients with newly diagnosed light chain (AL) amyloidosis, a rare blood cell disorder associated with the deterioration of vital organs, most notably the heart, kidneys and liver.[1] Longer-term results from a median follow-up of 20.3 months showed rates of hematologic complete response (hemCR) remained significantly higher in patients treated with DARZALEX FASPRO®...
Source: Johnson and Johnson - May 26, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news

Long-Term ERLEADA ® (apalutamide) Patient-Reported Outcomes Data in Metastatic Castration-Sensitive Prostate Cancer Demonstrate Maintenance of Health-Related Quality of Life for Patients
May 26, 2021 (RARITAN, N.J.) – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced patient-reported outcomes (PRO) data from the pre-specified final analysis of the Phase 3 TITAN study in patients with metastatic castration-sensitive prostate cancer (mCSPC). The TITAN study previously demonstrated statistically significant improvement in overall survival (OS) after a median follow-up of 44 months in patients receiving ERLEADA® plus androgen deprivation therapy (ADT).1 The new PRO data showed that the addition of ERLEADA® to ADT maintained patients’ health-related quality of lif...
Source: Johnson and Johnson - May 26, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news

Johnson & Johnson to Host Live ESG Investor Update Webcast
NEW BRUNSWICK, N.J., May 24, 2021 – Johnson & Johnson (NYSE: JNJ) announced today it will host an Environmental, Social and Governance (ESG) Investor Update Webcast at 8:00 a.m. (Eastern Time) on June 23, 2021. The webcast will discuss progress made in advancing a healthier world for all and will outline the Company’s ESG management approach around its priority ESG topics. Leaders from across the enterprise will share progress the Company has made in each of their respective areas to help drive long-term value creation and strengthen our ability to respond to the needs and expectations of all stakeholders.D...
Source: Johnson and Johnson - May 24, 2021 Category: Pharmaceuticals Tags: Our Company Source Type: news

Janssen Presents Updated Data on First-in-Class Talquetamab at ASCO Suggesting Deep and Durable Responses in Heavily Pretreated Patients with Multiple Myeloma
May 24, 2021 (RARITAN, N.J.) – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today follow-up data from the MonumenTAL-1 Phase 1 first-in-human dose-escalation study of the investigational product talquetamab, the only off-the-shelf T-cell redirecting bispecific antibody in clinical development to target both GPRC5D, a novel multiple myeloma target, and CD3 on T-cells (NCT03399799).[1],[2],[3] With a median follow-up of more than six months, updated results in 30 patients with relapsed or refractory multiple myeloma treated with talquetamab by subcutaneous (SC) administration at the recommend...
Source: Johnson and Johnson - May 24, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news

Janssen ’s Updated Phase 1 Results for Teclistamab Suggest Deep, Durable Responses in Patients with Heavily Pretreated Multiple Myeloma
We reported initial findings for teclistamab at ASCO 2020, and study updates have observed a deepening of responses that have shown to be durable in a significant percentage of patients with relapsed or refractory multiple myeloma,” said Amrita Y. Krishnan, M.D., Director of the Judy and Bernard Briskin Center for Multiple Myeloma Research and Chief, Division of Multiple Myeloma, Department of Hematology and Hematopoietic Cell Transplantation at City of Hope, and study investigator. “Teclistamab exposure was sustained across the dosing interval and exceeded target levels, and consistent T-cell activation was ob...
Source: Johnson and Johnson - May 24, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news

European Commission approves PONVORYTM (ponesimod), a Once Daily, Oral Therapy for the Treatment of Adults with Relapsing Forms of Multiple Sclerosis with Active Disease Defined by Clinical or Imaging Features
BEERSE, BELGIUM, May 24, 2021 – Janssen, the Pharmaceutical Companies of Johnson & Johnson, announced today that the European Commission (EC) has approved PONVORY (ponesimod) for the treatment of adult patients with relapsing multiple sclerosis (RMS) with active disease defined by clinical or imaging features.[4] “Relapsing multiple sclerosis is an unpredictable and complex disease that can present very differently from individual to individual, placing a heavy burden on the patient and their loved ones,” said Professor Gavin Giovannoni, MBBCh, PhD, FCP (Neurol., SA), FRCP, FRCPath, Professor of Neuro...
Source: Johnson and Johnson - May 24, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news

Janssen Presents Results of First Head-to-Head Study of Biologic Therapies in Patients with Moderate to Severe Crohn ’s Disease
SPRING HOUSE, PENNSYLVANIA, May 23, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced efficacy and safety data for STELARA® (ustekinumab) in Crohn’s disease (CD) and ulcerative colitis (UC),1-4including data from the SEAVUE study, the first head-to-head study of biologic therapies in patients with CD, presented in a Clinical Science Late-Breaking Abstract Plenary session.1 SEAVUE data showed treatment with STELARA demonstrated high rates of clinical remission, corticosteroid-free remission, clinical response and endoscopic response through one year in biologic-naïve p...
Source: Johnson and Johnson - May 24, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news

RYBREVANTTM (amivantamab-vmjw) Receives FDA Approval as the First Targeted Treatment for Patients with Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations
May 21, 2021 (HORSHAM, P.A.) – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the U.S. Food and Drug Administration (FDA) has granted the accelerated approval of RYBREVANTTM (amivantamab-vmjw) for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy.[1] RYBREVANTTM is the first fully-human, bispecific antibody approved for the treatment of patients with NSCLC t...
Source: Johnson and Johnson - May 21, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news

IMBRUVICA ® (ibrutinib)-Based Combination Regimen as a Fixed-Duration, First-Line Treatment for Chronic Lymphocytic Leukemia Demonstrates High Rates of Disease Control
May 19, 2021 (RARITAN, N.J.) – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced new data from the fixed-duration cohort of the investigational Phase 2 CAPTIVATE study, showing that 95 percent of patients treated with combined IMBRUVICA® plus venetoclax were alive and progression-free at two years.[1] Deep remissions were seen across all subgroups, including patients with high-risk chronic lymphocytic leukemia (CLL).1 In addition, long-term data from the RESONATE-2 (PCYC-1115/1116) study will be presented, providing the longest follow-up Phase 3 data for any BTK inhibitor to date. Thes...
Source: Johnson and Johnson - May 19, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news

Updated Amivantamab and Lazertinib Combination Data Demonstrate Durable Responses and Clinical Activity for Osimertinib-Relapsed Patients with EGFR-Mutated Non-Small Cell Lung Cancer
May 19, 2021 (RARITAN, N.J.) – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced updated data from the Phase 1 CHRYSALIS study showing treatment with amivantamab in combination with lazertinib led to a median duration of response (DOR) of 9.6 months in chemotherapy-naïve patients with non-small cell lung cancer (NSCLC) and epidermal growth factor receptor (EGFR) exon 19 deletion or L858R mutations whose disease had progressed after treatment with osimertinib.[1] These data, which will be presented in an oral presentation at the 2021 American Society of Clinical Oncology (ASCO) Annual ...
Source: Johnson and Johnson - May 19, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news

Late-Breaking Data at ACC.21 Show XARELTO ® (rivaroxaban) Plus Aspirin Significantly Reduced Total Ischemic Events in Peripheral Artery Disease (PAD) Patients After Lower-Extremity Revascularization
RARITAN, N.J., May 16, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson today presented new data from the Phase 3 VOYAGER PAD study which showed XARELTO® (rivaroxaban) (2.5 mg twice daily) in combination with aspirin (100 mg once daily) consistently reduced severe vascular events in patients with peripheral artery disease (PAD) after lower-extremity revascularization (LER) compared to aspirin alone regardless of whether it was the first, second, third, or subsequent event. The primary results of VOYAGER PAD showed that XARELTO® plus aspirin reduced first events by 15 percent among patients...
Source: Johnson and Johnson - May 16, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news

Johnson & Johnson Joins World Health Organization in Efforts to Prevent Spread of Ebola in West Africa
Discussions are ongoing with the U.S. Food and Drug Administration regarding the approval of the vaccine regimen in the U.S. WHO Prequalification is often a prerequisite for national registrations of new vaccines and medicines in developing countries. Johnson & Johnson now looks forward to collaborating with the WHO’s African Vaccine Regulatory Forum (AVAREF) to progress national registrations of the Company’s Ebola vaccine regimen. The Company’s Ebola vaccine regimen is designed to be used proactively to induce immunity against Ebola virus disease in adults and children. Johnson & Johnson’s...
Source: Johnson and Johnson - May 13, 2021 Category: Pharmaceuticals Tags: Our Company Source Type: news

Johnson & Johnson to Participate in Goldman Sachs 42nd Annual Global Healthcare Virtual Conference
New Brunswick, NJ (May 7, 2021) -- Johnson & Johnson (NYSE: JNJ) will participate in the Goldman Sachs 42nd Annual Global Healthcare Virtual Conference on Tuesday, June 8th. Mathai Mammen, Global Head, Research & Development Janssen Research Development will represent the Company in a session scheduled at 9:40 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. ### (Source: Johnson and Johnson)
Source: Johnson and Johnson - May 7, 2021 Category: Pharmaceuticals Tags: Our Company Source Type: news

Johnson & Johnson to Participate in Bernstein ’s 37th Annual Strategic Decisions Virtual Conference
New Brunswick, NJ (May 3, 2021) -- Johnson & Johnson (NYSE: JNJ) will participate in Bernstein’s 37th Annual Strategic Decisions Virtual Conference on Thursday, June 3rd. Alex Gorsky, Chairman and Chief Executive Officer and Joaquin Duato, Vice Chairman of the Executive Committee will represent the Company in a session scheduled at 10:00 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.### (Source: Johnson and Johnson)
Source: Johnson and Johnson - May 3, 2021 Category: Pharmaceuticals Tags: Our Company Source Type: news

Johnson & Johnson Single-Shot COVID-19 Vaccinations to Resume in the U.S. for All Adults Aged 18 and Older Following CDC and FDA Decision
NEW BRUNSWICK, N.J., April 23, 2021 – Johnson & Johnson (NYSE: JNJ) (the Company) today announced that vaccinations with the Company’s COVID-19 single-shot vaccine will resume for all adults aged 18 years and older in the U.S., under Emergency Use Authorization (EUA), following a decision from the United States Centers for Disease Control (CDC) and Food and Drug Administration (FDA).The decision was based on a recommendation from the U.S. CDC Advisory Committee on Immunization Practices (ACIP), which followed a rigorous evaluation of data relating to a very rare adverse event involving blood clots in combin...
Source: Johnson and Johnson - April 23, 2021 Category: Pharmaceuticals Tags: Our Company Source Type: news

Johnson & Johnson Statement on April 23 CDC Advisory Committee Meeting on Company COVID-19 Vaccine
NEW BRUNSWICK, N.J., April 23, 2021 – The U.S. Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) today voted to resume use of the Johnson & Johnson COVID-19 vaccine in persons 18 years of age and older in the U.S. population under the U.S. Food and Drug Administration’s (FDA) Emergency Use Authorization.Statement from Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer at Johnson & Johnson:“We are grateful to the Advisory Committee and its medical experts for the rigorous evaluation of our COVID-19 vaccine. T...
Source: Johnson and Johnson - April 23, 2021 Category: Pharmaceuticals Tags: Our Company Source Type: news

New Phase 3 Data Showed First-in-Class TREMFYA ® (guselkumab) Provided Durable Complete Skin Clearance Through Five Years in Moderate to Severe Plaque Psoriasis (PsO) and Robust Joint Symptom Improvement Through 52 Weeks in Active Psoriatic Arthritis (PsA)
SPRING HOUSE, PENNSYLVANIA, April 23, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced new Phase 3 data which showed TREMFYA® (guselkumab) sustained durable, complete skin clearance rates in a majority of adults with moderate to severe plaque psoriasis (PsO) through five years (252 weeks), a and improved disease activity and axial symptoms in adults with active psoriatic arthritis (PsA) through one year (52 weeks).1,2,3 These data are being presented at the American Academy of Dermatology Virtual Meeting Experience 2021, where Janssen will present a total of 22 abstracts. TREMF...
Source: Johnson and Johnson - April 23, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news

Johnson & Johnson Single-Shot COVID-19 Vaccine Phase 3 Data Published in New England Journal of Medicine
NEW BRUNSWICK, N.J., April 21, 2021 – Johnson & Johnson (the Company) today announced publication in the New England Journal of Medicine of primary data from the Phase 3 ENSEMBLE clinical trial for its single-dose COVID-19 vaccine, developed by the Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen). The publication of the primary analysis follows the topline efficacy and safety data announced in January, showing the trial met all primary and key secondary endpoints, and found that the Johnson & Johnson single-dose COVID-19 vaccine prevented hospitalization and death across all study participa...
Source: Johnson and Johnson - April 21, 2021 Category: Pharmaceuticals Tags: Our Company Source Type: news

Johnson & Johnson Statement on FDA Observations at Emergent BioSolutions (Updated 4/30)
NEW BRUNSWICK, N.J., April 21, 2021 – The quality and safety of our COVID-19 vaccine is paramount. On April 3, 2021, Johnson & Johnson announced it would increase its oversight of drug substance manufacturing at the Emergent BioSolutions Bayview facility, including additional controls and personnel, to ensure the quality standards of our company and the U. S. Food & Drug Administration (FDA) are met. Since then, the Company has worked closely with the U.S. government, including the FDA, and with the European Medicines Agency (EMA), concerning the FDA inspection at Emergent Bayview, which concluded on Tuesday,...
Source: Johnson and Johnson - April 21, 2021 Category: Pharmaceuticals Tags: Our Company Source Type: news

Johnson & Johnson Statement on FDA Observations at Emergent BioSolutions (Updated)
NEW BRUNSWICK, N.J., April 21, 2021 – The quality and safety of our COVID-19 vaccine is paramount. On April 3, 2021, Johnson & Johnson announced it would increase its oversight of drug substance manufacturing at the Emergent BioSolutions Bayview facility, including additional controls and personnel, to ensure the quality standards of our company and the U. S. Food & Drug Administration (FDA) are met. Since then, the Company has worked closely with the U.S. government, including the FDA, concerning the FDA inspection at Emergent Bayview, which concluded on Tuesday, April 20, 2021. Johnson & Johnson will ex...
Source: Johnson and Johnson - April 21, 2021 Category: Pharmaceuticals Tags: Our Company Source Type: news

Johnson & Johnson Statement on FDA Observations at Emergent BioSolutions
NEW BRUNSWICK, N.J., April 21, 2021 -- The quality and safety of our COVID-19 vaccine is paramount. On April 3, 2021, Johnson & Johnson announced it would increase its oversight of drug substance manufacturing at the Emergent BioSolutions Bayview facility, including additional controls and personnel, to ensure the quality standards of our company and the U.S. Food & Drug Administration (FDA) are met. Since then, the Company has worked closely with the U.S. government, including the FDA, concerning the FDA inspection at Emergent Bayview, which concluded on Tuesday, April 20, 2021. Johnson & Johnson will exercise...
Source: Johnson and Johnson - April 21, 2021 Category: Pharmaceuticals Tags: Our Company Source Type: news

Johnson & Johnson COVID-19 Vaccine Roll-out to Resume in Europe Following European Medicines Agency (EMA) ReviewEMA Confirms Overall Benefit-Risk Profile Remains Positive
NEW BRUNSWICK, N.J., April 20, 2021 – Johnson & Johnson (NYSE: JNJ) (the Company) today announced that the European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) has provided updated guidance for use of the Company’s COVID-19 vaccine and confirmed the overall benefit-risk profile remains positive. The guidance follows PRAC review of a small number of cases of a very rare adverse event involving blood clots in combination with low platelet counts that can occur within approximately one to three weeks following injection with the Company’s COVID-19 vaccine. As a resul...
Source: Johnson and Johnson - April 20, 2021 Category: Pharmaceuticals Tags: Our Company Source Type: news

Johnson & Johnson Announces Dividend Increase of 5.0%
New Brunswick, N.J. (April 20, 2021) – Johnson & Johnson today announced that its Board of Directors has declared a 5.0% increase in the quarterly dividend, from $1.01 per share to $1.06 per share.“Despite a year of unprecedented disruption, Johnson & Johnson remained committed to its established financial principles that strengthen our ability to drive long-term value for stakeholders. In recognition of our notable 2020 results, strong financial position and confidence in the future of Johnson & Johnson, the Board of Directors has voted to increase the quarterly dividend for the 59th consecutive ye...
Source: Johnson and Johnson - April 20, 2021 Category: Pharmaceuticals Tags: Our Company Source Type: news

Johnson & Johnson Reports 2021 First-Quarter Results
New Brunswick, N.J. (April 20, 2021) – Johnson & Johnson (NYSE: JNJ) today announced results for first-quarter 2021. “Johnson & Johnson delivered a strong first quarter performance led by the above market growth of our Pharmaceutical business and continued recovery in Medical Devices,” said Alex Gorsky, Chairman and Chief Executive Officer. “The ability to deliver these results while simultaneously advancing our robust pipeline of life-enhancing medicines, products and solutions during these times is a testament to the strength and resilience of our business and the dedication of the 135,000...
Source: Johnson and Johnson - April 20, 2021 Category: Pharmaceuticals Tags: Our Company Source Type: news

Janssen Provides Update on Phase 3 ACIS Study in Patients with Metastatic Castration-Resistant Prostate Cancer Treated with ERLEADA ® (apalutamide) and ZYTIGA® (abiraterone acetate) Plus Prednisone Combination
RARITAN, N.J., April 19, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that regulatory submissions based on the Phase 3 ACIS study, which evaluated the combination of ERLEADA® (apalutamide) and ZYTIGA® (abiraterone acetate) plus prednisone in patients with chemotherapy-naïve metastatic castration-resistant prostate cancer (mCRPC), will not be pursued. As presented at the American Society of Clinical Oncology’s Genitourinary (ASCO GU) Cancers Symposium in February 2021, the ACIS study met its primary endpoint of radiographic progression-free survival (rPFS); ho...
Source: Johnson and Johnson - April 19, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news

Johnson & Johnson Statement on CDC Advisory Committee Meeting on Company COVID-19 Vaccine
NEW BRUNSWICK, N.J., April 14, 2021 – The U.S. Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) convened today to consider reports of an extremely rare disorder involving blood clots in combination with low platelets observed in a small number of individuals following vaccination with the Johnson & Johnson COVID-19 vaccine. “The safety and well-being of the people who use our products is our number one priority, and we strongly support awareness of the signs and symptoms of this extremely rare event to ensure the correct diagnosis, appropriate treatment an...
Source: Johnson and Johnson - April 15, 2021 Category: Pharmaceuticals Tags: Our Company Source Type: news

Johnson & Johnson Statement on COVID-19 Vaccine (Updated)
NEW BRUNSWICK, N.J., April 13, 2021– The safety and well-being of the people who use our products is our number one priority. We are aware of an extremely rare disorder involving people with blood clots in combination with low platelets in a small number of individuals who have received our COVID-19 vaccine. The United States Centers for Disease Control (CDC) and Food and Drug Administration (FDA) are reviewing data involving six reported U.S. cases out of more than 6.8 million doses administered. Out of an abundance of caution, the CDC and FDA have recommended a pause in the use of our vaccine. In addition, we have ...
Source: Johnson and Johnson - April 13, 2021 Category: Pharmaceuticals Tags: Our Company Source Type: news

Johnson & Johnson Statement on COVID-19 Vaccine
NEW BRUNSWICK, N.J., April 13, 2021– The safety and well-being of the people who use our products is our number one priority. We are aware of an extremely rare disorder involving people with blood clots in combination with low platelets in a small number of individuals who have received our COVID-19 vaccine. The United States Centers for Disease Control (CDC) and Food and Drug Administration (FDA) are reviewing data involving six reported U.S. cases out of more than 6.8 million doses administered. Out of an abundance of caution, the CDC and FDA have recommended a pause in the use of our vaccine. In addition, we have ...
Source: Johnson and Johnson - April 13, 2021 Category: Pharmaceuticals Tags: Our Company Source Type: news

Johnson & Johnson to Participate in the BofA Securities Virtual 2021 Healthcare Conference
New Brunswick, NJ (April 12th, 2021) -- Johnson& Johnson (NYSE: JNJ) will participate in the BofA Securities Virtual 2021 Healthcare Conference on Tuesday, May 11th. Ashley McEvoy, Executive Vice President, Worldwide Chairman, Medical Devices will represent the Company in a session scheduled at 10:15 a.m. (Eastern Time). This conference call will be available to investors and other interested parties by visiting 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 - April 12, 2021 Category: Pharmaceuticals Source Type: news

New Real-World Observational Analysis of UPTRAVI ® (selexipag) Underscores the Importance of Risk Assessment for Treating Pulmonary Arterial Hypertension (PAH) Patients
SOUTH SAN FRANCISCO, CA – April 6, 2021 – Findings from an analysis of the first 500 patients enrolled in the SPHERE registry (SelexiPag: tHe usErs dRug rEgistry) found more than three-quarters (76%) of pulmonary arterial hypertension (PAH) patients treated with UPTRAVI® (selexipag) either maintained (56%) or reduced (20%) their one-year mortality risk score. The SPHERE results were published in the April issue of the Journal of Heart and Lung Transplantation (JHLT). SPHERE is an ongoing real-world, observational, user registry using two different risk assessment methods that describes the clinical characte...
Source: Johnson and Johnson - April 6, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news

Johnson & Johnson Statement on U.S. COVID-19 Vaccine Manufacturing (Updated)
New Brunswick, NJ (April 3, 2021) – Johnson & Johnson is assuming full responsibility regarding the manufacturing of drug substance for its COVID-19 vaccine at the Emergent BioSolutions Inc. Bayview facility. Specifically, the Company is adding dedicated leaders for operations and quality, and significantly increasing the number of manufacturing, quality and technical operations personnel to work with the Company specialists already at Emergent.Additional information:All Johnson & Johnson COVID-19 vaccine doses distributed to date have met rigorous Company and regulatory quality standards. The Company continu...
Source: Johnson and Johnson - April 4, 2021 Category: Pharmaceuticals Tags: Our Company Source Type: news

Johnson & Johnson Expands Phase 2a Clinical Trial of COVID-19 Vaccine Candidate to Include Adolescents
New Brunswick, NJ (April 2, 2021) – Johnson & Johnson (the Company) has begun vaccinating adolescent participants in the ongoing Phase 2a clinical trial for its COVID-19 vaccine candidate, developed by the Janssen Pharmaceutical Companies of Johnson & Johnson. “The COVID-19 pandemic has had a profound impact on adolescents, not just with the complications of the disease, but with their education, mental health, and wellbeing,” said Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer at Johnson & Johnson. “It is vital that we develop vaccines for eve...
Source: Johnson and Johnson - April 2, 2021 Category: Pharmaceuticals Tags: Our Company Source Type: news

Johnson & Johnson Statement on U.S. COVID-19 Vaccine Manufacturing
New Brunswick, NJ (March 31, 2021) – Since January of 2020, Johnson & Johnson has been working directly with governments, health authorities and other companies to help end the global pandemic. We continue to expect to deliver our COVID-19 vaccine at a rate of more than one billion doses by the end of 2021.We are pleased we have met our commitment to deliver enough single-shot vaccines by the end of March to enable the full vaccination of more than 20 million people in the United States. This is part of our plan to deliver 100 million single-shot vaccines to the U.S. during the first half of 2021, aiming to deliv...
Source: Johnson and Johnson - March 31, 2021 Category: Pharmaceuticals Tags: Our Company Source Type: news

Johnson & Johnson Announces Advance Purchase Agreement with the African Vaccine Acquisition Trust for the Company ’s COVID-19 Vaccine Candidate
NEW BRUNSWICK, NJ (March 29, 2021) - Janssen Pharmaceutica NV, one of the Janssen Pharmaceutical Companies of Johnson & Johnson (NYSE: JNJ) (the Company), has entered into an agreement with the African Vaccine Acquisition Trust (AVAT) to make available up to 220 million doses of its single-shot COVID-19 vaccine candidate to African Union’s 55 member states with delivery beginning in the third quarter of 2021. AVAT also has the potential to order an additional 180 million doses, for a combined total of up to 400 million doses through 2022. The availability of the vaccine candidate is subject to its successful appr...
Source: Johnson and Johnson - March 29, 2021 Category: Pharmaceuticals Tags: Our Company Source Type: news

Janssen Receives Positive CHMP Opinion for PONVORY ™ (ponesimod) for the Treatment of Adults With Relapsing Forms of Multiple Sclerosis With Active Disease Defined by Clinical or Imaging Features
BEERSE, BELGIUM, MARCH 26, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending marketing authorisation for PONVORY™ (ponesimod) for the treatment of adult patients with relapsing multiple sclerosis (RMS) with active disease defined by clinical or imaging features.[3]“Relapsing forms of multiple sclerosis (MS) have varied and often unpredictable symptoms, posing a unique human, societal and economic burden,” said Catherine T...
Source: Johnson and Johnson - March 26, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news