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News Breaks
June 1, 2014
19:15 EDTNVSNovartis announces results of Phase 2 trial of LDE225
Novartis announced the results of a pivotal Phase II trial demonstrating that patients with locally advanced, or metastatic basal cell carcinoma taking the investigational oral compound LDE225, sonidegib, had marked and sustained tumor shrinkage after a median follow-up of 13.9 months.The data were revealed for the first time in an oral presentation at the 50th Annual Meeting of the American Society of Clinical Oncology, ASCO, in Chicago. "These results represent an important milestone in the clinical development of LDE225, as well as in our research strategy to develop new therapies for patients with unmet needs," said Alessandro Riva, MD, Global Head, Novartis Oncology Development and Medical Affairs. "These data will form the basis for the filing of another important new medicine for a skin-related disease in which Novartis is building a leading position." The data from this pivotal trial will serve as the basis for worldwide regulatory filings for the 200 mg dose of LDE225 in advanced basal cell carcinoma.
News For NVS From The Last 14 Days
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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 Mylanís (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 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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