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News Breaks
March 6, 2014
05:30 EDTNVSNovartis announces Xolair approved in EU
Novartis announced that the European Commission has approved the use of Xolair, omalizumab, as an add-on therapy for the treatment of chronic spontaneous urticarial, or CSU, in adult and adolescent patients with inadequate response to H1-antihistamine treatment. The approved dose is 300 mg by subcutaneous injection every four weeks. The EU approval follows the Committee for Medicinal Products for Human Use positive opinion on Xolair, which was adopted based on positive and consistent results from three pivotal Phase III registration studies that involved nearly 1,000 patients with CSU not responding to H1-antihistamines. Xolair 300 mg met all primary and pre- specified secondary endpoints across these studies, which showed Xolair significantly improved itch and hives, including rapid itch relief, and in many cases completely cleared symptoms. Quality of life was also significantly improved for patients treated with Xolair 300 mg across the Phase III study program.
News For 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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05:31 EDTNVSNovartis reports Cosentyx 'superior' in head-to-head psoriasis study
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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.

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