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June 27, 2014
08:28 EDTJNJJanssen submits EU marketing application for Velcade for MCL
Janssen-Cilag International NV announced its submission of a type II variation to the European Medicines Agency to expand the label for VELCADE to include its use, in combination with rituximab, cyclophosphamide, doxorubicin and prednisone, for the treatment of adult patients with previously untreated Mantle Cell Lymphoma. MCL is a rare and aggressive blood cancer that usually occurs in older adults. VELCADE, in combination with other agents, is currently licensed to treat patients with Multiple Myeloma who have not yet had therapy or whose cancer has begun to progress after treatment. The submission is based on data from the landmark LYM-3002 trial. In results from this study, presented at the 50th Annual Meeting of the American Society of Clinical Oncology and the 19th Annual Congress of the European Hematology Association, significant benefits were seen when treating newly diagnosed patients with MCL using a VELCADE-based combination, compared to a widely used standard of care. Patients in the study were previously untreated for their MCL and were either ineligible, or not considered, for a bone marrow transplant. Compared to the treatment combination R-CHOPć, the VELCADE-based regimen, VR-CAP* significantly improved progression-free survival and showed improvements across a range of secondary endpoints.3 An independent review committee reported the increase in median PFS to be 59 percent, whereas the study investigators reported the increase in median PFS to be 96 percent.
News For JNJ From The Last 14 Days
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November 20, 2015
10:52 EDTJNJFDA approves new oral medication to treat multiple myeloma
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November 18, 2015
08:11 EDTJNJIMS Health forecasts global drug spending to increase 30% by 2020 to $1.4T
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08:11 EDTJNJAduro Biotech receives milestone payment from Janssen
Aduro Biotech (ADRO) announced that it has received a milestone payment from Janssen Biotech (JNJ) for Aduro's submission of an Investigational New Drug, or IND, Application to the FDA for ADU-741, a LADD immunotherapy product candidate for the treatment of prostate cancer. The IND will enable Janssen, Aduro's license partner for ADU-741, to initiate a multi-center Phase 1 trial to evaluate the safety and immunogenicity of intravenous administration of ADU-741 in patients with metastatic castration-resistant prostate cancer.
November 16, 2015
14:38 EDTJNJGenmab confirms FDA approval of Darzalex
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13:09 EDTJNJFDA approves Darzalex to treat multiple myeloma
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