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News For SHPG;JNJ;MRK;ABT;BMY;PFE;CELG;NVS;GSK;SNY;SHPG;JNJ;MRK;ABT;BMY;PFE;CELG;NVS;GSK;SNY From The Last 14 Days
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December 8, 2014
13:12 EDTMRKMerck paid full price but made good deal for Cubist, says UBS
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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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12:40 EDTMRKOn The Fly: Midday Wrap
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12:25 EDTMRKAntibiotic makers rise after Merck agrees to buy Cubist
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11:30 EDTNVSLeerink generics pharmaceutical analyst holds analyst/industry conference call
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08:30 EDTMRKMerck says deals with Cubist includes $250M break-up fee clause
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08:21 EDTMRKMerck says looked at all risks, including patent litgation, before Cubist deal
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08:11 EDTMRKCubist volatility elevated into Merck acquiring for $8.4B in cash
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08:08 EDTMRKMerck says about $9.5B of debt to be issued related to Cubist deal
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08:03 EDTPFEPfizer announces agreement with Spark Therapeutics to develop SPK-FIX
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07:36 EDTCELGAgios announces Celgene to extend discovery phase of collaboration to April 2016
Agios Pharmaceuticals (AGIO) announced that Celgene (CELG) has elected to extend the period of its exclusivity for an additional year to April 2016 under the global strategic collaboration agreement. The two companies have been working together since April 2010 to discover, develop and commercialize disease-altering therapies in oncology arising from Agios' cancer metabolism research platform. The terms of the collaboration extension are consistent with previously agreed upon financial terms. As a result of the extension, Celgene will maintain its exclusive option to drug candidates that emerge from Agios' cancer metabolism research platform through April 2016. Agios will receive a $20M payment. Following this extension, the discovery portion of the collaboration will expire on April 14, 2016. Under the terms of the original agreement announced in April 2010, Agios leads research, preclinical and early development efforts through Phase 1, while Celgene receives an option to obtain exclusive rights either upon IND acceptance or at the end of Phase 1, to further development and commercialize medicines emerging from Agios' cancer metabolism research. Celgene would lead and fund global development and commercialization of some of these drugs, and Agios would retain development and commercialization rights for certain drugs in the United States. On all programs, Agios is eligible to receive up to $120M in milestone-based payments as well as royalties on any sales.
07:35 EDTMRKAdvaxis reports FDA acceptance of IND application for ADXS-PSA combination trial
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07:17 EDTCELGCelgene price target raised to $131 from $120 at Cantor
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07:13 EDTMRKMerck to host conference call
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07:01 EDTMRKMerck to acquire Cubist for $102 per share in cash, or $9.5B
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07:00 EDTMRKMerck to acquire Cubist for $102 per share in cash
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05:53 EDTBMYStocks with implied volatility movement; BSX BMY
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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.
05:35 EDTCELGCelgene REVLIMID, low-dose dexamethasone increased PFS
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