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News Breaks
August 7, 2014
08:38 EDTNVS, ENTAEnanta's HCV NS5A inhibitor EDP-239 advances into combination studies
Enanta Pharmaceuticals (ENTA) announced that Novartis has advanced EDP-239, Enanta’s NS5A inhibitor for hepatitis C virus, into drug combination studies with alisporivir, a cyclophilin inhibitor being developed by Novartis (NVS). These combination studies are part of Enanta’s existing collaboration with Novartis for the development of new combination therapies for the treatment of HCV using Enanta’s NS5A inhibitors. The phase 1 combination study conducted by Novartis is investigating the pharmacokinetics, safety, and tolerability of alisporivir and EDP-239 when co-administered to healthy adult subjects and is scheduled to enroll 42 healthy subjects.
News For ENTA;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 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 15, 2015
19:08 EDTENTAEnanta confirms AbbVie hepatitis C treatment granted priority review in Japan
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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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05:30 EDTENTAEnanta announces data on regimens containing protease inhibitors paritaprevir
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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
10:02 EDTENTAOn The Fly: Analyst Initiation Summary
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08:13 EDTNVSJuno Therapeutics announces patent litigation settlement
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06:48 EDTENTAEnanta initiated with a Buy at Deutsche Bank
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