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News Breaks
July 2, 2014
06:28 EDTTEVAGeneric Copaxone approval likely later than expected, says Citigroup
Citigroup says the FDA has recently requested incremental data from the Copaxone generic filers, including both gene expression and immunogenicity data. Citi expects the first generic approval towards the end of 2014 at the earliest, later than the current Street expectations of Q3. Citi reiterates a Buy rating on Teva shares with a $70 price target.
News For TEVA From The Last 14 Days
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March 5, 2015
11:30 EDTTEVATeva volatility at low end of range on tight price movement
Teva March call option implied volatility is at 22, April and June is at 20, September is at 21; compared to its 26-week average of 23, suggesting decreasing near term price movement.
08:31 EDTTEVAANI Pharmaceuticals acquires generic drug product from Teva
ANI Pharmaceuticals (ANIP) announced that it has acquired the approved abbreviated new drug application for Flecainide Acetate tablets USP 50mg, 100mg and 150mg, previously marketed by Teva Pharmaceuticals (TEVA). According to IMS Health, the overall market for this product was approximately $39M in 2014. ANI has forty-seven generic drug products under development addressing a total annual market size of approximately $3B, based on data from IMS Health.
March 2, 2015
08:24 EDTTEVATeva announces sale of Sellersville, PA facility to G&W Laboratories
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07:20 EDTTEVACowen to hold a conference
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February 25, 2015
08:05 EDTTEVATeva says FDA accepts CEP-33237 NDA for review
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February 24, 2015
09:02 EDTTEVATeva announces phase 2b study of TEV-48125 achieved endpoints
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February 23, 2015
15:04 EDTTEVATeva announces publication of data on Phase III trials of reslizumab
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February 20, 2015
08:04 EDTTEVATeva to present new respiratory data at AAAAI
Teva Pharmaceutical Industries announced that four company-sponsored abstracts will be presented at the 2015 Annual Meeting of the American Academy of Allergy, Asthma and Immunology, or AAAAI, in Houston, Texas. Data to be presented include two replicate 52-week Phase III global studies of the company’s anti-IL5 monoclonal antibody, reslizumab, in patients with asthma and elevated blood eosinophils who were inadequately controlled on medium-to-high doses of inhaled corticosteroids with or without an additional controller. The data are scheduled for presentation on Monday, February 23 during an oral session titled “Asthma Therapy and Mechanisms.” Also to be presented are two Phase III studies of beclomethasone dipropionate 40mcg, which gained FDA approval in December 2014, and is now available for the treatment of nasal symptoms associated with allergic rhinitis in children 4-11 years of age. In addition, a dose-response study evaluating the safety and efficacy of fluticasone/salmeterol multidose dry-powder inhaler in patients 12 years of age and older with persistent asthma will be presented.
07:08 EDTTEVAAmerican Academy of Allergy, Asthma and Immunology to hold annual meeting
2015 Annual Meeting of AAAAI is being held in Houston, Texas on February 20-24.
February 19, 2015
17:03 EDTTEVATeva to initiate Phase 2b TV-45070 clinical trial
Xenon Pharmaceuticals (XENE) announced that its development and commercialization partner Teva Pharmaceutical (TEVA) will initiate a Phase 2b clinical trial of TV-45070 in patients with post-herpetic neuralgia, or PHN. The Phase 2b clinical trial in PHN will be a randomized, double-blind, placebo controlled, multi-site study to evaluate the efficacy and safety of TV-45070 in patients with PHN. The study will include three treatment groups to receive doses of 4% or 8% of TV-45070 or placebo, dosed twice daily. Approximately 330 patients will be enrolled in the study. Patients will be stratified into treatment groups based on their R1150W status, a genetic pain biomarker believed to be related to pain susceptibility. The primary endpoint of this study is the change from baseline to week 4 in the numeric rating scale, or NRS, scores. Secondary endpoints include additional pain measurement scores at specified daily time points, the percentage of patients with greater than 30% and greater than 50% improvement in pain scores, quality of life measurements and adverse events measurements. The first patient is anticipated to be dosed in March, and the anticipated completion date for the Phase 2b clinical trial is mid-2016.

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