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News Breaks
May 13, 2014
08:31 EDTTEVATeva announces FDA acceptance of sNDA filing for pediatric indication of QNASL
Teva Pharmaceuticals Industries announced that the U.S. FDA has accepted for review the company’s supplemental new drug application for a lower dose QNASL Nasal Aerosol for the treatment of seasonal and perennial allergic rhinitis in children 4-11 years of age. QNASL is a waterless intranasal corticosteroid spray currently available for the treatment of nasal symptoms of seasonal allergic rhinitis and perennial allergic rhinitis in patients 12 years of age and older. The sNDA filing includes data from three double-blind, placebo-controlled studies that evaluated the safety and efficacy of QNASL in children with allergic rhinitis. The data demonstrated that once-daily treatment with QNASL provided significant nasal allergy symptom relief in pediatric subjects with SAR and PAR when compared with placebo. In all three studies the safety profile of QNASL was similar to that of placebo and adverse events were consistent with those seen in previous clinical studies.
News For TEVA From The Last 14 Days
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May 28, 2015
09:07 EDTTEVAFTC, Teva reach $1.2B settlement over Provigil
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08:55 EDTTEVAXenon Pharmaceuticals sees IND for phase 1 trial of XEN801 in mid-2015
Xenon Pharmaceuticals (XENE) announced that Dr. Simon Pimstone, Xenon's President and CEO, will present a business update, including progress toward milestones, at the Jefferies Global Healthcare Conference on Tuesday, June 2. Xenon's partner Teva Pharmaceutical (TEVA) is conducting a randomized, double-blind, placebo-controlled Phase 2b clinical trial for TV-45070 in osteoarthritis. Results from the trial are now expected late in the second quarter or early in the third quarter of 2015. Xenon's partner Genentech, a member of the Roche Group (RHHBY), is currently conducting a Phase 1 clinical trial for GDC-0276, which is expected to complete patient enrollment in the second half of 2015. Xenon expects to file an investigational new drug equivalent application to initiate a Phase 1 clinical trial of XEN801, a stearoyl Co-A desaturase or SCD1 inhibitor for treatment of acne, in mid-2015. If supported by positive data from the Phase 1 trial, Xenon plans to initiate a proof-of-concept Phase 2 clinical trial in the second half of 2015. Xenon expects to file an investigational new drug application for Xenon's Nav1.6 sodium channel inhibitor for Dravet Syndrome in 2016.
06:11 EDTTEVATeva takes 1.35% stake in Mylan, says 'ready to meet' on deal
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May 27, 2015
12:10 EDTTEVATeva to sweeten offer for Mylan before July shareholder vote, NY Post says
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08:24 EDTTEVAFDA reports paragraph IV patent challenge received for Treanda
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May 19, 2015
06:08 EDTTEVAPerrigo CEO says would talk with Mylan, but at a higher price, Globes reports
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May 15, 2015
17:08 EDTTEVASoros Fund gives quarterly update on stakes
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09:31 EDTTEVAAmerican Thoracic Society to hold a conference
ATS 2015 Conference is being held in Denver on May 15-20.
08:12 EDTTEVATeva migraine treatment data positive, says Bernstein
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08:04 EDTTEVATeva to present new respiratory data at 2015 ATS conference
Teva Pharmaceutical Industries announced that three company-sponsored abstracts will be presented at the 2015 American Thoracic Society International Conference in Denver, Colorado on May 15-19.Data to be presented include a Phase III study examining the functionality, reliability, accuracy and overall patient satisfaction of ProAir RespiClick inhalation powder, which gained approval from the U.S. FDA in March 2015. ProAir RespiClick is now available by prescription and is indicated for the treatment or prevention of bronchospasm with reversible obstructive airway disease and for the prevention of exercise-induced bronchospasm in patients 12 years of age and older. Additional Phase III data to be presented include a late-breaking abstract highlighting an interim analysis of the long-term safety and efficacy of Teva’s investigational anti-IL-5 therapy, reslizumab, in patients with asthma and elevated blood eosinophils. A third abstract to be presented includes data from a dose-ranging study of fluticasone propionate multi-dose, dry-powder inhaler in adolescent and adult patients with asthma.
May 14, 2015
08:35 EDTTEVATeva says data present case for TEV-48125 progression to Phase III
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07:44 EDTTEVAInternational Headache Society to hold a conference
17th Congress of the International Headache Society is being held in Valencia, Spain on May 14-17.

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