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News Breaks
February 9, 2013
14:51 EDTNVS, ARRY, AZNArray expects to make progress on generating data on hematology programs
In a press release Array BioPharma said : During 2013, Array (ARRY) expects to make substantial progress in generating data to inform registration study decisions for our wholly-owned hematology programs, ARRY-520 and ARRY-614. Array-invented MEK162 will be tested in a Phase 3 trial in NRAS melanoma which is scheduled to start in April 2013, as well as BRAF mutant melanoma later in 2013 (with Novartis (NVS)). Also, AstraZeneca (AZN) recently announced a potential start of a Phase 3 trial with Array-invented selumetinib in non-small cell lung cancer during the second half of 2013.
News For ARRY;NVS;AZN From The Last 14 Days
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April 20, 2015
07:20 EDTNVS, ARRYAmerican Association for Cancer Research to hold annual meeting
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07:18 EDTNVSAmerican Academy of Neurology to hold annual meeting
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06:02 EDTAZNClovis pullback on Astra data a buying opportunity, says Mizuho
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April 17, 2015
06:52 EDTAZNAstraZeneca granted FDA orphan drug designation for selumetinib
AstraZeneca announced that the FDA has granted orphan drug designation for the MEK inhibitor selumetinib, for the treatment of uveal melanoma, a rare disease in which cancer cells form in the tissues of the eye.
06:50 EDTAZNAstra reports median progression free survival of 13.5 months in AURA study
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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.
10:51 EDTARRYOptions with increasing implied volatility
Options with increasing implied volatility: PNK ARRY FOSL NSAM WUBA ARCP CSCO
09:12 EDTAZNAstraZeneca granted orphan status for melanoma treatment
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07:58 EDTAZNAstraZeneca's MedImmune, Immunocore announce new collaboration agreement
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05:27 EDTNVSAlcon receives FDA approval of AcrySof IQ ReSTOR +2.5 Diopter IOL
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April 15, 2015
11:50 EDTAZNAstraZeneca initiated with a Buy at Societe Generale
07:41 EDTAZNEBD Group to hold a forum
ChinaBio Partnering Forum 2015 is being held in Shanghai, China on April 15-16.
April 14, 2015
12:06 EDTAZNFDA panel accepts Onglyza's safety profile in 13-1 vote
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07:15 EDTAZNFDA Endocrinologic & Metabolic Drugs Advisory Committee holds a meeting
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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.
08:58 EDTAZNMerck may have positive read through from briefing docs, says SunTrust
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08:54 EDTAZNAstraZeneca has negative read through from briefing docs, says SunTrust
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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.
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