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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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December 19, 2014
11:08 EDTJNJJohnson & Johnson receives positive CHMP opinion to extend Velcade indication
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December 17, 2014
09:04 EDTJNJHalozyme enters collaboration pact with Janssen for ENHANZE Technology
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09:02 EDTJNJHalozyme enters collaboration pact with Janssen for ENHANZE Technology
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08:06 EDTJNJInovio appoints Zane Yang as VP, Clinical Development, Oncology
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December 16, 2014
07:20 EDTJNJGeron announces early HSR clearance for collaboration with Janssen
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December 12, 2014
14:01 EDTJNJGenOn Energy to receive $3M milestone payment in Janssen collaboration
Genmab announced it has reached a milestone in its DuoBody technology platform collaboration with Janssen Biotech (JNJ), triggering a $3M payment. The milestone payment is for pre-clinical progress with a DuoBody product candidate targeting cancer. Today's news will not impact Genmab's 2014 financial guidance.
December 9, 2014
05:50 EDTJNJPharmacyclics data demonstrates safety, durability response
New, 27-month IMBRUVICA median follow-up data announced by Pharmacyclics (PCYC) support the use of IMBRUVICA over longer periods of time in patients with relapsed/refractory mantle cell lymphoma, or MCL, an aggressive type of lymphoma. More than 30% of IMBRUVICA patients remained progression-free after two years with no new or unexpected adverse events occurring during that time. Nearly half of the 111 patients treated were still living at the time of the data analysis. A second Phase II trial looked at IMBRUVICA's efficacy and safety as a single-agent treatment for MCL patients who previously had received rituximab combination therapy and at least two cycles of bortezomib. IMBRUVICA combination therapy resulted in an 88% overall response rate in MCL patients with a complete response rate of 40%. IMBRUVICA is jointly developed and commercialized by Pharmacyclics and Janssen Biotech, a unit of Johnson and Johnson (JNJ).
05:43 EDTJNJPharmacyclics reports IMBRUVICA data shows 84% PFS rate at one year
Pharmacyclics (PCYC) announced new, longer term data in IMBRUVICA patients with relapsed/refractory chronic lymphocytic leukemia, or CLL, including high-risk CLL patients with deletion 17p. Results from the Phase III RESONATE trial demonstrated an 84% progression-free survival, or PFS, rate in all patients with previously treated CLL or small lymphocytic lymphoma, or SLL, who received IMBRUVICA and a 94% PFS rate in patients who received only one prior therapy at 12 months. Separately, follow-up data was reported from Phase II RESONATE-17, or PCYC-1117, the largest prospective trial dedicated to studying CLL or SLL patients with del 17p. The data showed that IMBRUVICA was associated with an 83% overall response rate, or ORR, at a median follow up of 11.5 months. At 12 months, the estimated PFS was 79%. These results and additional data were presented here at the 56th American Society of Hematology, or ASH, Annual Meeting, highlighting IMBRUVICA's sustained efficacy in relapsed/refractory patients who have received at least one prior therapy. IMBRUVICA combination therapy resulted in an 88% overall response rate in MCL patients with a complete response rate of 40%. IMBRUVICA is jointly developed and commercialized by Pharmacyclics and Janssen Biotech, a unit of Johnson and Johnson (JNJ).
05:27 EDTJNJPharmacyclics IMBRUVICA Phase II combination data shows positive profile
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December 7, 2014
14:54 EDTJNJIMBRUVICA data suggests promise in multiple myeloma
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