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News Breaks
April 11, 2013
11:18 EDTNTE, EXEL, IMOS, NIHD, CTICHigh option volume stocks: NIHD EXEL CTIC IMOS NTE
News For NIHD;EXEL;CTIC;IMOS;NTE From The Last 14 Days
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December 15, 2014
05:24 EDTEXELExelixis announces Genentech files NDA for cobimetinib, vemurafenib combination
Exelixis (EXEL) announced its collaborator Genentech, a member of the Roche Group (RHHBY), has completed the filing of its New Drug Application, or NDA, with the FDA for cobimetinib, a specific MEK inhibitor discovered by Exelixis, in combination with vemurafenib for previously untreated patients with unresectable locally advanced or metastatic melanoma harboring a BRAF V600 mutation. Cobimetinib has received Fast Track designation by the FDA. Roche submitted a Marketing Authorization Application for the combination to the European Medicines Agency in September of this year. The NDA is based on data from the coBRIM trial, a phase 3 pivotal trial conducted by Genentech in 495 patients with BRAF V600 mutation-positive unresectable locally advanced or metastatic melanoma.
December 11, 2014
07:28 EDTEXELCBI to hold a summit
2nd Specialty Data Optimization Summit is being held in Philadelphia on December 11.
December 10, 2014
10:10 EDTIMOSHigh option volume stocks
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06:04 EDTIMOSChipMOS now expects to report Q4 results at high-end of guidance
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06:03 EDTIMOSChipMOS reports Nov. revenue up 20.2% to $62.9M
December 9, 2014
05:56 EDTCTICCTI BioPharma presents Pacritinib data at ASH meeting
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December 7, 2014
14:25 EDTCTICCTI BioPharma announces analysis of kinase inhibition by pacritinib
CTI BioPharma announced that an analysis of kinase inhibition by pacritinib, a next generation oral multikinase inhibitor in Phase 3 clinical development, demonstrated a unique kinome profile among agents in development for myelofibrosis and suggests potential therapeutic benefit across a spectrum of blood-related cancers. Researchers presented the findings from this analysis at the 56th American Society of Hematology Annual Meeting and Exposition held December 6-9 in San Francisco, CA."The kinome profile of pacritinib shown in this analysis highlights how pacritinib is different from other JAK inhibitors that are currently on the market and in development for myelofibrosis," said Srdan Verstovsek, M.D., Ph.D., Director, Clinical Research Center for MPNs at The University of Texas MD Anderson Cancer Center and principal investigator for the Phase 3 PERSIST-2 trial of pacritinib. "One of the findings observed in clinical trials to date is the lack of myelosuppression seen with other treatments. Pacritinib's potent inhibition of FLT3, c-fms, IRAK1 and c-kit, all critical targets in hematologic malignancies, highlights its potential therapeutic utility in other indications, such as AML, MDS, CMML and CLL." The in vitro profiling of pacritinib across a panel of kinases showed the inhibition of all members of the JAK/FLT pathways, with the exception of JAK1. The JAK/FLT pathways are frequently dysregulated in many types of cancers. Additionally, pacritinib was found to inhibit the kinases c-fms and IRAK1. Disruption in the c-fms and IRAK1 pathways have been indicated to be involved in acute myeloid leukemia, myelodysplastic syndrome, chronic myelomonocytic leukemia and chronic lymphocytic leukemia. CTI believes the clinical efficacy and reduced myelosuppression seen in Phase 2 trials of pacritinib in patients with myelofibrosis is also likely attributable to this unique kinase inhibition profile. "These data not only demonstrate the unique attributes of pacritinib compared to other marketed agents or agents in development for the treatment of myelofibrosis, many of which have activity against JAK1, but also show the potential for broader use in other blood-related cancers," said Jack Singer, M.D., Executive Vice President, Global Medical and Translational Medicine at CTI and lead author of the analysis. "We are excited to pursue additional indications, such as AML, MDS, CMML and CLL, all of which are currently being evaluated in Phase 2 clinical trials, so we can potentially offer these patients an effective and less toxic treatment option."
14:10 EDTCTICAmerican Society of Hematology to hold a meeting
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14:08 EDTCTICCTI BioPharma to hold a cocktail reception
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