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News Breaks
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-CHOP†, 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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September 2, 2014
15:00 EDTJNJWright Medical hip suit weakness would be buying opportunity, says Brean Capital
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August 31, 2014
14:04 EDTJNJWorldwide Business Research to hold a conference
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August 28, 2014
17:42 EDTJNJJ&J begins sales process for its medical device unit Cordis, WSJ says
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August 25, 2014
08:27 EDTJNJJanssen Affiliate Cilag acquires Covagen, terms not disclosed
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07:03 EDTJNJVIVUS acquires patents from Janssen Pharmaceuticals
VIVUS (VVUS) announced the acquisition of a group of patents from Janssen Pharmaceuticals (JNJ) covering uses of topiramate as monotherapy and in combination with other pharmaceutical agents to treat a variety of medical conditions. Janssen has agreed to dismiss the lawsuit it brought against VIVUS on August 22, 2014 in the U.S. District Court for the District of Delaware. VIVUS will pay a one-time upfront fee and a royalty to Janssen on Qsymia product sales for an assignment of these topiramate-related patents owned by Janssen. VIVUS has an option to buy out the royalty for a predetermined amount.
August 21, 2014
05:42 EDTJNJIllumina announces strategic partnership with AstraZeneca, Sanofi, Janssen
Illumina (ILMN) announced it has formed collaborative partnerships with leading pharmaceutical companies to develop a universal next-generation sequencing, or NGS,-based oncology test system. The system will be used for clinical trials of targeted cancer therapies with a goal of developing and commercializing a multi-gene panel for therapeutic selection, resulting in a more comprehensive tool for precision medicine. Initial strategic partners include AstraZeneca (AZN), Janssen Biotech, a Johnson & Johnson (JNJ) company, and Sanofi (SNY). Illumina is working with the strategic partners to develop assays that detect and measure multiple variants simultaneously to support partners’ clinical trials, with the objectives of securing regulatory agency approvals and test commercialization. In parallel, Illumina is working with key thought leaders to set standards for NGS-based assays in routine clinical oncology practice, as well as to define regulatory frameworks to enable this new testing paradigm. Together, Illumina and its strategic partners aim to transition from single-analyte companion diagnostics to panel-based assays that select for “companion therapeutics.”

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