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News from Janssen Research & Development, LLC A wide array of domestic and global news stories; news topics include politics/government, business, technology, religion, sports/entertainment, science/nature, and health/lifestyle. Articles that appear in this section may be written in English or other languages.

Latest

Dec 11, 2017, 08:30 ET Janssen Submits Supplemental New Drug Application to FDA Seeking New Indications for XARELTO® (rivaroxaban) for Patients with Chronic Coronary and/or Peripheral Artery Disease (CAD/PAD)

Janssen Research & Development, LLC (Janssen) today announced it has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and...


Dec 05, 2017, 08:05 ET Phase 3 Study Evaluating IMBRUVICA® (ibrutinib) in Combination with Rituximab in Waldenström's Macroglobulinemia Met Primary Endpoint

Janssen Research & Development, LLC (Janssen) announced that the Phase 3 iNNOVATE (PCYC-1127) study evaluating IMBRUVICA® (ibrutinib) in...


Nov 15, 2017, 13:12 ET New Janssen Healthy Minds Videos Explore Latest Alzheimer's Research and Perspectives of Caregiver with Risk for Dementia

As part of National Alzheimer's Disease Awareness Month in November, Janssen Research & Development, LLC ("Janssen") today launched a new...


Nov 07, 2017, 08:00 ET New Phase 2 Data Show Treatment With TREMFYA® (guselkumab) Improved Psoriatic Arthritis Symptoms Through One Year

Janssen Research & Development, LLC (Janssen) announced today longer-term results from a Phase 2 study investigating TREMFYA® (guselkumab), the...


Nov 06, 2017, 08:00 ET STELARA® (ustekinumab) Shows Positive Results In Treatment Of Systemic Lupus Erythematosus In Phase 2 Trial

Janssen Research & Development, LLC (Janssen) announced today positive results from a randomized, placebo-controlled Phase 2 study...


Oct 11, 2017, 08:30 ET Janssen Research & Development Establishes First-of-Its-Kind Mobile Medication and Data Management Technology Platform for Industry Use

Janssen Research & Development, LLC (Janssen) today announced that it has established the Integrated Smart Trial & Engagement Platform...


Oct 10, 2017, 16:37 ET New Videos about Treatment-Resistant Depression Launch on World Mental Health Day to Bring Attention to Complex, Debilitating Condition

Janssen Research & Development, LLC ("Janssen") recognizes World Mental Health Day today by launching two new videos about treatment-resistant...


Oct 05, 2017, 16:15 ET NAVIGATE ESUS Study Stopped Early Due to Comparable Efficacy in Treatment Arms

Janssen Research & Development, LLC and its development partner Bayer today announced the Phase III NAVIGATE ESUS study, evaluating the...


Oct 02, 2017, 08:00 ET Janssen Submits Supplemental New Drug Application (sNDA) to U.S. FDA Seeking New Indication for INVOKANA® (canagliflozin) to Reduce the Risk of Major Adverse Cardiovascular Events (MACE) Based on Landmark CANVAS Program

Janssen Research & Development, LLC (Janssen) announced today it has submitted a supplemental New Drug Application (sNDA) to the U.S. Food...


Sep 25, 2017, 08:00 ET Janssen Submits New Drug Application to U.S. Food and Drug Administration for the First Darunavir-Based Single Tablet Regimen for the Treatment of HIV-1

Janssen Research & Development, LLC today announced the submission of a new drug application (NDA) to the U.S. Food and Drug Administration...


Sep 16, 2017, 02:00 ET New Two-Year TREMFYA™ (guselkumab) Data Show Patients With Moderate To Severe Plaque Psoriasis Achieved Consistent Rates Of Skin Clearance

Janssen Research & Development, LLC (Janssen) presented today new longer-term data from the open-label extension of the VOYAGE 1 trial...


Aug 21, 2017, 08:00 ET New XARELTO® (rivaroxaban) Data at ESC Congress 2017 Includes Late-Breaking Results from Landmark Phase 3 COMPASS Study

New data from the landmark Phase 3 COMPASS study evaluating the use of XARELTO® (rivaroxaban) in coronary and peripheral artery disease (CAD and...


Jun 28, 2017, 08:30 ET U.S. FDA Grants Priority Review of XARELTO® (rivaroxaban) sNDA for a 10 mg Dose to Reduce the Risk of Recurrent Venous Thromboembolism (VTE)

Janssen Research & Development, LLC announced today the U.S. Food and Drug Administration (FDA) accepted for Priority Review a...


Apr 04, 2017, 07:05 ET U.S. FDA Accepts for Review the Application of Ibrutinib (IMBRUVICA®) for Chronic Graft-Versus-Host-Disease (cGVHD) After Failure of One or More Lines of Systemic Therapy

Janssen Research & Development, LLC announced today the U.S. Food and Drug Administration (FDA) has accepted for review a supplemental New Drug...


Mar 03, 2017, 07:00 ET New Results From Second Phase 3 Study Show Significant Efficacy Of Guselkumab And Superiority Versus Humira® In Treatment Of Moderate To Severe Plaque Psoriasis

Janssen Research & Development, LLC (Janssen) announced today new findings from two pivotal Phase 3 studies reporting the efficacy and safety...


Feb 08, 2017, 15:23 ET Phase 3 COMPASS Study of XARELTO® (rivaroxaban) Stopping Early for Efficacy; Study Meets Primary Endpoint of Prevention of Major Adverse Cardiac Events in Patients with Coronary Artery Disease or Peripheral Artery Disease

Janssen Research & Development, LLC (Janssen) today announced that the Phase 3 COMPASS trial, evaluating the efficacy and safety of XARELTO®...


Feb 02, 2017, 08:00 ET Janssen Human Microbiome Institute Announces Multiple Collaborations to Accelerate the Translation of Microbiome Science into Health Solutions

Janssen Research & Development, LLC (Janssen) announced today several new collaborations through its Janssen Human Microbiome Institute (JHMI)...


Nov 16, 2016, 11:00 ET New Phase 3 Monotherapy Study of Sirukumab Versus Humira® and Sirukumab Data in an Anti-TNF Refractory Population Reported in the Treatment of Moderately to Severely Active Rheumatoid Arthritis

Janssen Research & Development, LLC (Janssen) announced today results from two pivotal Phase 3 studies evaluating subcutaneous (SC) sirukumab,...


Nov 15, 2016, 08:00 ET Janssen Next-Generation Biologic Guselkumab Shows Promise In The Treatment Of Psoriatic Arthritis In Phase 2 Trial

Janssen Research & Development, LLC (Janssen) announced today positive efficacy and safety results from a Phase 2 study investigating...


Nov 14, 2016, 08:00 ET New Phase 3 Data Show SIMPONI ARIA® (golimumab) Significantly Improved Signs and Symptoms in Patients with Active Ankylosing Spondylitis

Janssen Research & Development, LLC (Janssen) announced today new findings from a pivotal Phase 3 study showing the efficacy and safety profile...


Nov 03, 2016, 09:59 ET ASH 2016: Janssen to Present 43 Abstracts with Data on Ibrutinib, Daratumumab and Other Compounds Showing Treatment Advances in Malignant and Non-Malignant Hematologic Conditions

New data for the first-in-class BTK inhibitor ibrutinib and immunotherapy daratumumab are among the 13 oral presentations from Janssen Research...


Oct 27, 2016, 09:13 ET Janssen Partners with University of Pennsylvania and Castleman Disease Collaborative Network to Launch First Global Patient Registry for Castleman Disease

Janssen Research & Development, LLC announced today the launch of ACCELERATE, a first-of-its-kind, patient-driven natural history registry...


Oct 01, 2016, 02:00 ET New Phase 3 Data Show Significant Efficacy Versus Placebo And Superiority Of Guselkumab Versus Humira® In Treatment Of Moderate To Severe Plaque Psoriasis

 Janssen Research & Development, LLC (Janssen) announced today findings from the first of three pivotal Phase 3 studies evaluating...


Sep 09, 2016, 02:30 ET Janssen to Present Data from Nine Abstracts on INVOKANA® (canagliflozin) at 2016 European Association for the Study of Diabetes Annual Meeting

 Janssen Research & Development, LLC (Janssen) today announced that nine presentations on INVOKANA® (canagliflozin) will be featured...