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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.
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June 17, 2015
07:21 EDTJNJGeneric ADHD drugs still sold despite FDA non-equivalance finding, NYT reports
The FDA announced last November that two generic versions of Johnson & Johnson's (JNJ) Concerta ADHD drug, one made by Mallinckrodt (MNK) and the other by UCB, could no longer be considered the equivalent of the branded drug after tests and analyses suggested that their effectiveness began to wear off much more quickly, but the drugs are still being sold despite an FDA mandated deadline having passed for the companies to either prove the drugs were equivalent or remove them from the market, said The New York Times. The report noted a third generic product, sold by Actavis (AGN), was found to be equivalent to the branded Concerta. Reference Link

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