World Health Organization Strategic Advisory Group of Experts (SAGE) Interim Recommendation Supports Use of Johnson & Johnson COVID-19 Vaccine as a Booster
NEW BRUNSWICK, N.J., December 9, 2021 – Johnson & Johnson (NYSE: JNJ) (the Company) today announced the interim recommendation by the Strategic Advisory Group of Experts on Immunization (SAGE) for the World Health Organization (WHO) supporting the use of the Johnson & Johnson COVID-19 vaccine as a booster shot in persons aged 18 years and above. The WHO recommend the booster shot should be administered two to six months after the primary vaccination. SAGE advises WHO on global vaccine and immunization policies, and its recommendations provide guidance on the use of vaccines supplied through the COVAX Facility, a ...
Source: Johnson and Johnson - December 9, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news
Johnson & Johnson COVID-19 Booster, Administered Six Months After Two-Dose Regimen of BNT162b2, Shows Substantial Increase in Antibody and T-cell Responses
NEW BRUNSWICK, N.J., DECEMBER 5, 2021 – Johnson & Johnson (NYSE: JNJ) (the Company) today announced preliminary results from an independent study, including a subset of participants from the Janssen-sponsored COV2008 study, conducted by Dan Barouch, M.D., Ph.D., et al. of Beth Israel Deaconess Medical Center (BIDMC), which showed that a booster shot of the Johnson & Johnson COVID-19 vaccine (Ad26.COV2.S), administered at six months after a two-dose primary regimen of BNT162b2, increased both antibody and T-cell responses. These results demonstrate the potential benefits of heterologous boosting (mix-and-match). T...
Source: Johnson and Johnson - December 5, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news
Latest Phase 3 Data for First-in-Class TREMFYA ® (guselkumab) Demonstrates Significant and Durable Improvement in Signs and Symptoms of Active Psoriatic Arthritis while Maintaining its Safety Profile in Patients with Inadequate Response to Tumor Necrosis Factor Inhibition (TNFi-IR)
SPRING HOUSE, PENNSYLVANIA, December 3, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced new TREMFYA® (guselkumab) efficacy and safety data from the Phase 3b COSMOS trial published in Annals of the Rheumatic Diseases (ARD), evaluating this selective interleukin (IL)-23 inhibitor in adults with active psoriatic arthritis (PsA) who demonstrated inadequate efficacy or intolerance to tumor necrosis factor inhibition (TNFi).1 Results showed significantly higher proportions of patients treated with TREMFYA had improvement in joint signs and symptoms and complete skin clearance versus placeb...
Source: Johnson and Johnson - December 3, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news
Janssen Seeks Approval of IMBRUVICA ®(ibrutinib) in a Fixed-Duration Regimen for Patients with Untreated Chronic Lymphocytic Leukaemia (CLL)
BEERSE, BELGIUM, 30 November 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the submission of a Type II variation application to the European Medicines Agency (EMA) seeking approval of a new treatment option for IMBRUVICA® (ibrutinib) as a fixed-duration combination with venetoclax (I+V) for adult patients with previously untreated chronic lymphocytic leukaemia (CLL)."Ibrutinib was the first approved Bruton’s tyrosine kinase inhibitor and over the past seven years has become a key treatment for CLL and some other B-cell malignancies, treating more than 250,000 patients globally,...
Source: Johnson and Johnson - November 30, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news
Johnson & Johnson COVID-19 Vaccine Fully Approved by Health Canada to Prevent COVID-19 in Individuals 18 years and Older
Toronto ON, 24 November 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that Health Canada has approved its single-shot COVID-19 vaccine to prevent COVID-19 in individuals 18 years of age and older. This decision was based on scientific evidence, including initial data from the Phase 3 ENSEMBLE study that demonstrated the vaccine was 85 percent effective in preventing severe disease, and showed protection against COVID-19 related hospitalization and death, beginning 28 days after vaccination. “We are delighted by Health Canada’s decision to approve the Johnson & Johnson COVID-...
Source: Johnson and Johnson - November 24, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news
Janssen Reports Positive Topline Week 48 Phase 2 Results for TREMFYA ® (guselkumab) in Adults With Moderately to Severely Active Crohn's Disease
SPRING HOUSE, PENNSYLVANIA, November 17, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced topline results from the Phase 2 GALAXI 1 clinical trial which showed rates of clinical remission (Crohn’s Disease Activity Index [CDAI]<150) previously reported at week 12 increased at week 48 among adults with moderately to severely active Crohn’s disease (CD) treated with TREMFYA® (guselkumab).1 At week 48, 65 percent of patients receiving TREMFYA achieved clinical remission. TREMFYA is under investigation and not currently approved for the treatment of CD in the U.S.2Janssen previously...
Source: Johnson and Johnson - November 17, 2021 Category: Pharmaceuticals Source Type: news
Late-Breaking Phase 2 Data for Investigational Oral Factor XIa Inhibitor Milvexian Suggest Favorable Antithrombotic Profile Across a Wide Range of Doses
This study establishes proof-of-principle for milvexian as a differentiated antithrombotic agent,” said Jeffrey Weitz, M.D., Professor of Medicine & Biochemistry and Biomedical Sciences at McMaster University and Executive Director of the Thrombosis and Atherosclerosis Research Institute.[i] “Furthermore, the consistently low rates of bleeding across a 16-fold range of milvexian doses suggest that it has a wide therapeutic window, which opens the opportunity to explore milvexian across a broad range of patients including those for whom factor Xa inhibitors are underutilized or not indicated.” The trial met both o...
Source: Johnson and Johnson - November 15, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news
Johnson & Johnson Enters into Agreement to Provide its Single-Shot COVID-19 Vaccine for the World ’s Most Vulnerable People through Novel Humanitarian Buffer
NEW BRUNSWICK, NJ (November 10, 2021) – Johnson & Johnson (NYSE: JNJ) (the Company) has entered into an agreement with the U.S. Government and Gavi, the Vaccine Alliance (Gavi), to enable access to its single-shot COVID-19 vaccine through a novel mechanism – the COVAX Humanitarian Buffer – that will serve to protect the world’s most vulnerable people. The first deliveries to the COVAX Humanitarian Buffer are anticipated to begin in the coming days.The COVAX Humanitarian Buffer is part of the COVAX Facility and is designed to ensure that people in conflict zones or humanitarian settings can access COVID-19 vacci...
Source: Johnson and Johnson - November 10, 2021 Category: Pharmaceuticals Tags: Our Company Source Type: news
Janssen to Present the Strength and Promise of its Hematologic Malignancies Portfolio and Pipeline at ASH 2021
RARITAN, N.J., November 4, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that more than 45 company-sponsored abstracts, including 11 oral presentations, plus more than 35 investigator-initiated studies will be featured at the American Society of Hematology (ASH) Annual Meeting and Exposition. ASH is taking place at the Georgia World Congress Center in Atlanta and virtually from December 11-14, 2021.“We are committed to advancing the science and treatment of hematologic malignancies and look forward to presenting the latest research from our robust portfolio and pipeline during ASH...
Source: Johnson and Johnson - November 5, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news
Janssen Announces Extension of U.S. FDA BLA PDUFA Date for BCMA CAR-T Ciltacabtagene Autoleucel
RARITAN, N.J., November 1, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) date to February 28, 2022 for the ciltacabtagene autoleucel (cilta-cel) Biologics License Application (BLA). Cilta-cel is a B-cell maturation antigen (BCMA) CAR-T therapy that is being investigated for the treatment of adults with relapsed and/or refractory multiple myeloma. The FDA extended the PDUFA date to allow sufficient time to review information recently submitted by the company pertaining to an updated an...
Source: Johnson and Johnson - November 1, 2021 Category: Pharmaceuticals Tags: Latest News Source Type: news
New Comprehensive Phase 3 Data Show First-in-Class TREMFYA ® (guselkumab) Provided Durable Improvements in Measures of Psoriatic Arthritis (PsA) Disease Activity Through Two Years
SPRING HOUSE, PENNSYLVANIA, November 1, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced comprehensive efficacy and safety data from the DISCOVER–2 trial of TREMFYA® (guselkumab) were published in Arthritis & Rheumatology, representing the final results of the first two-year clinical trial investigating a selective interleukin (IL)-23 inhibitor therapy in active psoriatic arthritis (PsA).1 Results show a majority of TREMFYA-treated biologic-naïve adult patients with active PsA achieved improvements in joint signs and symptoms (American College of Rheumatology [ACR] 20/50/70)a a...
Source: Johnson and Johnson - November 1, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news
New Analyses Suggest Favorable Results for STELARA ® (ustekinumab) When Used as a First-Line Therapy for Bio-Naïve Patients with Moderately to Severely Active Crohn’s Disease and Ulcerative Colitis
SPRING HOUSE, PENNSYLVANIA, October 25, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced data from two new analyses of STELARA® (ustekinumab) for the treatment of adults with moderately to severely active Crohn’s disease (CD) and ulcerative colitis (UC).1,2 In a modelled analysisa focused on treatment sequencing using data from randomized controlled trials, network meta-analysis and literature, results showed patient time spent in clinical remission or response was highest when STELARA was used as a first-line advanced therapy for bio-naïve patients with moderately to severely acti...
Source: Johnson and Johnson - October 25, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news
U.S. CDC Advisory Committee Unanimously Recommends Johnson & Johnson COVID-19 Vaccine as a Booster for All Eligible Individuals Who Receive Authorized COVID-19 Vaccines
NEW BRUNSWICK, N.J., October 21, 2021 – Johnson & Johnson (the Company) today announced that the U.S. Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP), has recommended its COVID-19 vaccine as a booster for all eligible individuals who receive an authorized COVID-19 vaccine. “Today’s recommendation supports the use of the Johnson & Johnson COVID-19 vaccine as a booster for eligible individuals in the U.S. regardless of which vaccine they initially receive,” said Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer at Jo...
Source: Johnson and Johnson - October 21, 2021 Category: Pharmaceuticals Source Type: news
Johnson & Johnson COVID-19 Vaccine Booster Shot Authorized for Emergency Use by U.S. FDA
NEW BRUNSWICK, N.J., October 20, 2021 – Johnson & Johnson (NYSE: JNJ) (the Company) today announced the U.S. Food and Drug Administration (FDA) has issued Emergency Use Authorization (EUA) for a booster dose of the Johnson & Johnson COVID-19 vaccine for adults aged 18 and older at least two months following primary vaccination with single-shot Johnson & Johnson COVID-19 vaccine; and for eligible individuals who received a different authorized or approved COVID-19 vaccine. The Johnson & Johnson booster shot will be the same formulation and dosage as the primary shot. The EUA follows a unanimous recommendat...
Source: Johnson and Johnson - October 20, 2021 Category: Pharmaceuticals Tags: Latest News Source Type: news
Johnson & Johnson COVID-19 Vaccine Booster Shot Unanimously Recommended for Emergency Use Authorization by U.S. FDA Advisory Committee
NEW BRUNSWICK, N.J., October 15, 2021 – Johnson & Johnson (NYSE: JNJ) (the Company) today announced the U.S. Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) unanimously voted 19-0 to recommend Emergency Use Authorization (EUA) for a booster dose of the Johnson & Johnson COVID-19 vaccine for adults aged 18 and older at least two months following initial vaccination with the single-shot vaccine. The vote was based on findings from two Company clinical trials, including the Phase 3 ENSEMBLE 2 study, which evaluated a booster dose of the Johnson & Johnso...
Source: Johnson and Johnson - October 15, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news
