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News Breaks
January 13, 2014
05:34 EDTNVS, CTICCell Therapeutics to reacquire rights to Pixuvri, Opaxio from Novartis
Cell Therapeutics (CTIC) announced that it has reached an agreement with Novartis (NVS) to reacquire rights to two anti-cancer compounds Pixuvri and Opaxio. Under the terms of the previous agreement, CTI has been responsible for development and commercialization activities and expenses for both compounds to date. Upon the effective date of termination, CTI will regain all rights that had been granted to Novartis. In exchange for Novartis' agreement to return such rights to CTI, CTI has agreed to make certain potential payments to Novartis based on sales of Opaxio and PIXUVRI and on any sublicense and certain other amounts payable to CTI.
News For CTIC;NVS From The Last 14 Days
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December 17, 2014
15:09 EDTNVSNovartis unit gets FDA approval for swimmer’s ear treatment
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07:29 EDTNVSFDA PDUFA Date for Novartis Bexsero is December 17, 2014
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December 16, 2014
08:47 EDTNVSHemispherx Ampligen provides anti-tumor activity
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07:06 EDTNVSBioLineRx and Novartis enter into strategic collaboration agreement
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05:48 EDTNVSNovartis gains FDA approval for Signifor LAR
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December 12, 2014
08:36 EDTNVSNovartis reports BOLERO-1 trial did not meet primary objective
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05:31 EDTNVSNovartis reports Cosentyx 'superior' in head-to-head psoriasis study
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December 9, 2014
05:56 EDTCTICCTI BioPharma presents Pacritinib data at ASH meeting
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December 8, 2014
13:07 EDTNVSNovartis announces data from Jakavi trial
Novartis (NVS) announced data from the largest clinical trial of myelofibrosis patients treated with Jakavi, supporting the safety profile and efficacy benefit as measured in primary and secondary endpoints respectively. In an analysis of 1,144 patients treated with Jakavi to date in this ongoing expanded access study, 69% of patients achieved >50% reduction in spleen size from baseline and patients also experienced a clinically meaningful improvement in myelofibrosis symptom score, important treatment goals for patients with myelofibrosis. Findings from the study were presented at the 56th Annual Meeting of the American Society of Hematology in San Francisco, California. Novartis research and development efforts, in collaboration with Incyte Corporation (INCY), include early-phase and post-marketing studies in myelofibrosis and other myeloproliferative neoplasms. More than 50 abstracts on ruxolitinib are being presented at ASH, including three oral presentations exploring combinations of ruxolitinib with various investigational compounds, evaluating the possibility of simultaneously targeting multiple cancer pathways that may be involved in the pathogenesis of myelofibrosis. The JUMP study is a Phase IIIb, expanded-access trial for countries with no access to Jakavi outside of a clinical trial. The open-label, multicenter study analyzed 1,144 enrolled myelofibrosis patients who received daily starting doses of either 5 mg, 15 mg or 20 mg of Jakavi twice daily based on platelet counts at baseline. The primary endpoint is assessment of safety and tolerability of Jakavi. Overall, the safety and efficacy profile of Jakavi was consistent with previous studies.
13:05 EDTNVSNovartis reports six-year results from Phase III ENESTnd study
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11:30 EDTNVSLeerink generics pharmaceutical analyst holds analyst/industry conference call
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05:42 EDTNVSSandoz Phase III data shows filgrastim has similar safety, efficacy as NEUPOGEN
Sandoz, a Novartis (NVS) company, announced Phase III data that demonstrated similarity of its investigational biosimilar filgrastim compared to the US-licensed reference product, Amgen's (AMGN) NEUPOGEN in the prevention of severe neutropenia in patients with breast cancer receiving neoadjuvant myelosuppressive chemotherapy. The study also showed that repeated switching at each cycle between the investigational biosimilar and the originator filgrastim showed no impact on efficacy, safety or immunogenicity. The PIONEER study was a Phase III study designed to compare the efficacy and safety of the investigational biosimilar and the reference product with respect to mean duration of severe neutropenia following Cycle 1 chemotherapy. PIONEER was a randomized, double-blind, four-group, multi-center non-inferiority trial conducted at 27 centers. The trial randomized 218 breast cancer patients receiving neoadjuvant myelosuppressive chemotherapy.
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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