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News Breaks
June 3, 2014
10:51 EDTINCY, NVSNovartis, Incyte announce results from RESPONSE trial evaluating ruxolitinib
Novartis (NVS) and Incyte (INCY) announced results from the first-ever pivotal Phase III study evaluating a JAK 1/2 inhibitor for the treatment of polycythemia vera. Jakavi, or ruxolitinib, improved hematocrit control without the need for phlebotomy and reduced spleen size in patients with PV who are resistant to or intolerant of hydroxyurea[. Findings are being presented at the 50th Annual Meeting of the American Society of Clinical Oncology. Ruxolitinib was well tolerated and adverse events were consistent with those previously seen in ruxolitinib studies in PV and myelofibrosis. Within the first 32 weeks of treatment, Grade 3 or 4 hematologic AEs in the ruxolitinib treatment arm were anemia and thrombocytopenia and fewer patients treated with ruxolitinib experienced thromboembolic events when compared to those who received best available therapy. The most common non-hematologic AEs were headache, diarrhea and fatigue. Additionally, 3.6% of patients randomized to the ruxolitinib treatment arm discontinued treatment due to AEs compared to 1.8% on the best available therapy arm. Data from the RESPONSE trial will support worldwide regulatory submissions planned this year.
News For NVS;INCY From The Last 14 Days
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April 17, 2015
07:33 EDTINCYIncyte no longer expects to initiate INCB39110 trial in pancreatic cancer in '15
Incyte Corporation announced that eleven abstracts detailing its emerging development pipeline will be presented at the 2015 American Association for Cancer Research Annual Meeting in Philadelphia, PA. These abstracts include characterizations of Incyte’s FGFR, BRD and PIM inhibitors as potential targeted therapies for cancer, as well as data supporting the potential immuno-therapeutic activity of the company’s portfolio of JAK and PI3Kδ inhibitors alone and in combination, including with epacadostat, Incyte’s leading IDO1 inhibitor. The company also provided an updated presentation of its clinical portfolio, which now includes INCB54828, a potent and selective FGFR inhibitor and INCB50465, a PI3Kδ inhibitor, which entered clinical trials in Q1 2015 for solid tumors and B-lymphoid malignancies. INCB54329, a bromodomain inhibitor, is expected to enter clinical trials in Q2 2015 in hematology oncology. Additional first-line pancreatic cancer patients are being recruited into the expansion cohort of JAK1-selective inhibitor INCB39110 in combination with gemcitabine and nab-paclitaxel to continue the dose optimization phase of this proof-of-concept trial. Incyte therefore no longer expects to initiate a pivotal trial of INCB39110 in first-line pancreatic cancer during 2015.
April 16, 2015
15:40 EDTNVSGeneric Copaxone approval a bit early but expected, says BMO Capital
BMO Capital believes FDA approval for Sandoz (NVS) and Momenta's (MNTA) generic 20mg Copaxone came slightly earlier than the market expected, but the firm added that the generic threat has been well expected. The firm added that it appears Mylan’s (MYL) generic Copaxone hasn't been approved yet, leaving a "legitimate question" about why the FDA approved one generic and not the other. BMO thinks Teva's rate of conversion to the 40mg dose will help retain patients on the Copaxone franchise and it keeps an Outperform rating on Teva shares.
12:37 EDTNVSMomenta confirms Glatopa approval, to receive $10M payment
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12:35 EDTNVSSandoz receives FDA approval for Glatopa as generic competitor to Copaxone
Sandoz, a Novartis (NVS) company, announced the U.S. approval of Glatopa, the first generic version of Teva's (TEVA) Copaxone 20 mg/ml one-time-daily multiple sclerosis therapy. Glatopa, developed in collaboration with Momenta (MNTA) and produced entirely in the U.S., is indicated for the treatment of patients with relapsing forms of MS, including those who have experienced a first clinical episode and have magnetic resonance imaging features consistent with MS.
05:27 EDTNVSAlcon receives FDA approval of AcrySof IQ ReSTOR +2.5 Diopter IOL
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April 14, 2015
07:31 EDTINCYIncyte to establish European headquarters in Geneva, Switzerland
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April 13, 2015
16:51 EDTNVSDiplomat Pharmacy to dispense Novartis' JADENU
Diplomat Pharmacy is set to distribute JADENU, a drug recently approved by the U.S. FDA to treat patients with chronic iron overload. JADENU is a new oral formulation of EXJADE for the treatment of chronic iron overload due to blood transfusions in patients age 2 and older, and chronic iron due to NTDT in patients age 10 and older.
05:21 EDTNVSNovartis to present new data that confirms high efficacy of Gilenya
Novartis announced new Gilenya analyses to be presented at the 67th American Academy of Neurology, or AAN, Annual Meeting in Washington, DC, from April 18-25, showing how Novartis is advancing methods assessing the impact of relapsing multiple sclerosis, or RMS, for patients and physicians. Data will show how adding brain shrinkage to an existing tool to assess MS disease activity will give a more precise prediction of the likelihood of future disability progression. Accurate assessment of disease activity is key to guide treatment decisions in RMS. A pooled analysis from the two-year phase III FREEDOMS and FREEDOMS II trials will further confirm Gilenya's high efficacy in previously-treated patients with highly-active RMS in achieving 'no evidence of disease activity' across four key measures: relapses, MRI lesions, brain shrinkage and disability progression. Achieving NEDA4 is especially critical for highly-active RMS patients, who are likely to lose more physical and cognitive functions over time despite being treated.
April 9, 2015
09:25 EDTNVSPiper Jaffray pharmaceuticals analysts hold an analyst/industry conference call
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09:17 EDTNVSCourt lifts injunction on sales of generic copy of Spectrum's Fusilev
The U.S. Court of Appeals for the Federal Circuit yesterday issued an order that lifted a temporary injunction put in place March 6 that had blocked Novartis' (NVS) Sandoz unit from selling a generic version of Spectrum Pharmaceuticals' (SPPI) colorectal cancer treatment Fusilev. The appeals court ruled that Spectrum failed to meet the requirements for an injunction pending appeal.
April 8, 2015
16:22 EDTNVSOn The Fly: Closing Wrap
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14:23 EDTNVSAdditional bidders for Perrigo could emerge after Mylan offer, says Stifel
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April 7, 2015
07:14 EDTNVSEyeforpharma to hold a summit
Philadelphia 2015 Commercial Pharma Summit is being held in Philadelphia on April 7-8.
April 6, 2015
08:13 EDTNVSJuno Therapeutics announces patent litigation settlement
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