Janssen Research & Development - Articles and news items

Supplemental New Drug Application for ibrutinib submitted to FDA

Industry news / 14 September 2015 / Victoria White

The supplemental New Drug Application has been submitted for front-line use of ibrutinib in patients with chronic lymphocytic leukaemia…


Phase 2b findings demonstrate efficacy of guselkumab in treatment of moderate to severe plaque psoriasis

Industry news / 9 July 2015 / Victoria White

A trial of has shown up to 86% of patients with psoriasis receiving guselkumab achieved a PGA score of cleared psoriasis or minimal psoriasis at week 16…

Trabectedin shown to improve disease control in patients with advanced soft tissue sarcoma

Industry news / 3 June 2015 / Victoria White

Janssen Research & Development has announced data from a Phase 3 study of trabectedin (YONDELIS) in patients with two common types of soft tissue sarcoma…

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Janssen collaborates to further evaluate SIRTURO® (bedaquiline) in new multidrug-resistant tuberculosis treatment regimens

Industry news / 6 November 2014 / Janssen

Janssen Research & Development, LLC announced a collaboration with the International Union Against Tuberculosis and Lung Disease (The Union) to include SIRTURO® (bedaquiline) in the STREAM Study…

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Bristol-Myers Squibb, Pharmacyclics and Janssen announce clinical collaboration to evaluate OPDIVO® (nivolumab) and IMBRUVICA®(ibrutinib) in non-Hodgkin lymphoma

Industry news / 13 October 2014 / Bristol-Myers Squibb Company

Bristol-Myers Squibb Company, Pharmacyclics, Inc., and Janssen Research & Development, LLC announced they have entered into a clinical trial collaboration agreement to evaluate the safety, tolerability and preliminary efficacy of Bristol-Myers Squibb’s investigational PD-1 immune checkpoint inhibitor OPDIVO® (nivolumab)…

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Janssen submits supplemental New Drug Application to U.S. FDA for OLYSIO™ for once-daily use in combination with Sofosbuvir for 12 weeks for the treatment of adult patients with genotype 1 chronic hepatitis C

Industry news / 8 May 2014 / Johnson & Johnson

Filing Includes data from treatment-naïve patients with advanced fibrosis and null responders with all stages of liver fibrosis…

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Supplemental New Drug Application for IMBRUVICA™ (ibrutinib) submitted to the U.S. FDA

Industry news / 9 April 2014 / Johnson & Johnson

Janssen Research & Development, LLC announced the submission of a supplemental New Drug Application for IMBRUVICA™ to the U.S. Food and Drug Administration by its collaboration partner Pharmacyclics, Inc…

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FDA Advisory Committee recommends against approval of the use of oral anticoagulant XARELTO® to reduce the risk of thrombotic cardiovascular events in patients with Acute Coronary Syndrome

Industry news / 16 January 2014 / Johnson & Johnson

Janssen is seeking approval of rivaroxaban at a proposed dose of 2.5 mg twice daily (BID) for a 90 day treatment duration…


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