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January 11, 2013
10:39 EDTJNJJanssen-Cilag says EC approves broader indication for ZYTIGA
Janssen-Cilag International announced that the European Commission has approved an extension to the license of the oral, once-daily medication ZYTIGA. The approved broader indication for ZYTIGA now includes its use, in combination with prednisone or prednisolone, for the treatment of metastatic castration-resistant prostate cancer, in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated.Until now, ZYTIGA with prednisone and prednisolone has only been approved to treat men with mCRPC whose disease has progressed on or after a docetaxel-based chemotherapy regimen. The ECís decision follows recommendations from the Committee for Medical Products for Human Use of the European Medicines Agency that were based on data from the Phase III COU-AA-302 study.
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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