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Experimental treatment for Niemann-Pick disease appears safe
An experimental drug has appeared to slow the progression of Niemann-Pick disease type C1...
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Janssen Research & Development
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Supplemental New Drug Application for ibrutinib submitted to FDA
14 September 2015 | By Victoria White
A supplemental New Drug Application (sNDA) for Imbruvica (ibrutinib) has been submitted to the US Food and Drug Administration (FDA) for front-line use in patients with chronic lymphocytic leukaemia (CLL).
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Phase 2b findings demonstrate efficacy of guselkumab in treatment of moderate to severe plaque psoriasis
9 July 2015 | By 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...
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Trabectedin shown to improve disease control in patients with advanced soft tissue sarcoma
3 June 2015 | By 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
Janssen Research & Development, LLC (Janssen) today announced a collaboration with the International Union Against Tuberculosis and Lung Disease (The Union) to include SIRTURO® (bedaquiline) in the STREAM Study. The STREAM study is an ongoing, multi-centre international randomized controlled trial to evaluate a standardized treatment regimen of anti-tuberculosis drugs for patients…
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Bristol-Myers Squibb, Pharmacyclics and Janssen announce clinical collaboration to evaluate OPDIVO® (nivolumab) and IMBRUVICA®(ibrutinib) in non-Hodgkin lymphoma
13 October 2014 | By Bristol-Myers Squibb Company
Bristol-Myers Squibb Company (NYSE:BMY), Pharmacyclics, Inc. (NASDAQ:PCYC), and Janssen Research & Development, LLC announced today 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) in combination with IMBRUVICA® (ibrutinib), an oral Bruton's…
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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
8 May 2014 | By 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
9 April 2014 | By Johnson & Johnson
Janssen Research & Development, LLC (“Janssen”) today announced the submission of a supplemental New Drug Application (sNDA) for IMBRUVICA™ (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™ study in relapsed or…
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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
16 January 2014 | By 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...
