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News Breaks
March 18, 2013
09:26 EDTNVS, INCYIncyte discloses patient treated with ruxolitinib develops PML
Incyte Corporation (INCY) disclosed in a regulatory filing that it was informed last week of a case of progressive multifocal leukoencephalopathy, or PML, in a 75 year old male patient from the United Kingdom with myelofibrosis treated with ruxolitinib. Ruxolitinib is marketed by the company as Jakafi in the United States and by Novartis (NVS) as Jakavi outside the United States, Incyte said. Incyte stated: "It has not been determined whether development of PML in this case was related to the use of ruxolitinib. An independent assessment to confirm the diagnosis and evaluate the causality assessment provided by the investigator is planned. This is the only known case of PML in the approximately 9,800 myelofibrosis patients treated with ruxolitinib worldwide in clinical trials or with commercial product...The Company has informed the U.S. Food and Drug Administration of this case and, as part of its standard procedure for sharing available information in a timely manner, is in the process of informing investigators in its clinical trials." The company added that there are reports in medical literature that "suggest that patients with myeloproliferative neoplasms, including myelofibrosis, may be at higher risk of developing PML." In pre-market trading, Incyte shares fell over 13% to $21.58.
News For INCY;NVS From The Last 14 Days
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December 22, 2014
11:09 EDTNVSFTC puts conditions on Lilly's proposed acquisition of Novartis Animal Health
Global pharmaceutical company Eli Lilly and Company (LLY) has agreed to divest its Sentinel product line of medications for treating heartworm disease in dogs in order to settle FTC charges that its proposed $5.4B acquisition of Novartis (NVS) Animal Health would likely be anticompetitive. Under the proposed settlement, Eli Lilly will divest its Sentinel product line and associated assets to the French pharmaceutical company, Virbac. Indianapolis-based Eli Lilly, through its Elanco Animal Health division, and Switzerland-based Novartis AG’s Novartis Animal Health business unit both develop and market a wide range of animal health products, including medications to treat diseases and conditions affecting pets and livestock. Reference Link
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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08:01 EDTINCYPiper predicts two large-cap biotechs could be acquired in 2015
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05:31 EDTNVSNovartis reports Cosentyx 'superior' in head-to-head psoriasis study
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December 9, 2014
07:11 EDTINCYEli Lilly and Incyte announce Phase 3 RA-BEACON study met primary endpoint
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December 8, 2014
13:07 EDTNVS, INCYNovartis 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.

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