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Last updated on April 19, 2014 at 21:20 EDT

Latest Janssen Research & Development LLC Stories

2014-04-14 23:06:18

MD Biosciences enters into an agreement with Janssen Research & Development, LLC to screen an extensive library of compounds with its proprietary Senerga® Phenotypic Screening Platform. Senerga®PSP is based on three matrices covering pathways related to inflammatory, metabolic, cardiovascular, and CNS diseases in addition to delivering preliminary toxicology data. St Paul, MN (PRWEB) April 14, 2014 MD Biosciences announces that it has entered into a research agreement with...

2014-04-08 08:31:42

New submission based on positive Phase 3 data from the RESONATE(TM) trial RARITAN, N.J., April 8, 2014 /PRNewswire/ -- Janssen Research & Development, LLC ("Janssen") today announced the submission of a supplemental New Drug Application (sNDA) for IMBRUVICA(TM) (ibrutinib) to the U.S. Food and Drug Administration (FDA) by its collaboration partner Pharmacyclics, Inc. This regulatory submission is based on data from the Phase 3 RESONATE(TM) study in relapsed or refractory chronic...

2014-04-01 08:28:25

RARITAN, N.J., April 1, 2014 /PRNewswire/ -- Janssen Research & Development, LLC (Janssen), today announced it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for a once-daily fixed-dose antiretroviral combination tablet containing darunavir, a protease inhibitor developed by Janssen R&D Ireland and marketed as PREZISTA(®) in the U.S., with cobicistat, an investigational pharmacokinetic enhancer or boosting agent, developed...

2014-03-31 08:29:45

RARITAN, N.J., March 31, 2014 /PRNewswire/ -- Janssen Research & Development, LLC (Janssen) announced today it is adding three new clinical trials to its EXPLORER global cardiovascular research program for XARELTO(®) (rivaroxaban), the most studied and broadly indicated oral Factor Xa inhibitor in the world today. The additional trials will evaluate rivaroxaban for the treatment or prevention of deep vein thrombosis (DVT) and pulmonary embolism (PE) in pediatric and other patient...

2014-03-24 08:28:42

Results from Phase 2b X-PLORE Study through Week 40 Report Efficacy of Guselkumab across Multiple Dosing Regimens and Compared with Adalimumab DENVER, March 24, 2014 /PRNewswire/ -- New findings presented for the first time at the 2014 Annual Meeting of the American Academy of Dermatology (AAD) showed up to 86 percent of patients with moderate to severe plaque psoriasis receiving guselkumab (CNTO 1959) achieved a Physician's Global Assessment (PGA) score of cleared or minimal at week 16, the...

2014-03-20 08:29:49

Independent Data Monitoring Committee Recommends Halting Trial and Unblinding Data Based on Treatment Efficacy TITUSVILLE, N.J., March 20, 2014 /PRNewswire/ -- Janssen Research & Development, LLC announced today that following an Independent Data Monitoring Committee (IDMC) recommendation based on positive efficacy, it has halted early a Phase 3 clinical study of paliperidone palmitate 3-month formulation, an investigational treatment for symptoms of schizophrenia in adults. "We are...

2014-02-21 08:25:23

Trial Seeks to Examine the Effects of INVOKANA® on the Progression of Diabetic Nephropathy RARITAN, N.J., Feb. 21, 2014 /PRNewswire/ -- Janssen Research & Development, LLC (Janssen) today announced the initiation of CREDENCE (Canagliflozin and Renal Events in Diabetes with Established Nephropathy Clinical Evaluation), a global, multicenter study of INVOKANA(®) (canagliflozin). This Phase 3 study is a randomized, double-blind, placebo-controlled, parallel group trial designed to enroll...

2014-02-20 08:28:52

GHENT, Belgium, Feb. 20, 2014 /PRNewswire/ -- The Museum Dr. Guislain in Ghent, Belgium and Janssen Research & Development, LLC ("Janssen"), today announced they are seeking nominations for the third Dr. Guislain "Breaking the Chains of Stigma" Award. The award honors an individual, project or organization that has made an exceptional contribution to reduce stigma associated with mental illness. Nominations from people and organizations anywhere in the world can be submitted at...

2014-02-14 08:26:09

RARITAN, N.J., Feb. 14, 2014 /PRNewswire/ -- Janssen Research & Development, LLC (Janssen) announced today the U.S. Food and Drug Administration (FDA) issued complete response letters (CRLs) regarding supplemental New Drug Applications (sNDAs) for the use of XARELTO(®) (rivaroxaban), an oral anticoagulant, to reduce the risk of secondary cardiovascular events - defined as heart attack, stroke or death - in patients with acute coronary syndrome (ACS) and to reduce the risk of stent...

2014-01-16 16:24:28

RARITAN, N.J., Jan. 16, 2014 /PRNewswire/ -- Janssen Research & Development, LLC (Janssen) announced today the U.S. Food and Drug Administration's (FDA) Cardiovascular and Renal Drugs Advisory Committee has voted against the approval of the use of XARELTO(®) (rivaroxaban), an oral anticoagulant, to reduce the risk of thrombotic cardiovascular events in patients with Acute Coronary Syndrome (ACS) in combination with standard antiplatelet therapy. Janssen is seeking approval of...