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News Breaks
April 19, 2014
18:32 EDTTEVASupreme Court denies Teva stay in generic Copaxone case
Teva Pharmaceutical Industries announced that while the Chief Justice of the United States found that Teva had demonstrated “a fair prospect of success on the merits” in its appeal of a decision from the United States Court of Appeals for the Federal Circuit that invalidated the claim of U.S. Patent 5,800,808, he denied the company’s application to stay the Federal Circuit's decision due to the potential for the company to recover patent infringement damages. The ‘808 patent expires on September 1, 2015 and claims a process for manufacturing the active ingredient of Teva’s relapsing-remitting multiple sclerosis, RRMS, product, Copaxone 20mg/mL. Teva will continue pursuing its appeal in the Supreme Court and defending its intellectual property for Copaxone. Teva previously prevailed in the District Court, which upheld the validity of nine Copaxone patents, including the ‘808 patent. A ruling last year by the Court of Appeals for the Federal Circuit upheld some of the COPAXONE patents that expire in May, while invalidating the ‘808 patent that is the subject of Teva’s now-granted certiorari petition. Any purported generic version of Copaxone would be required to obtain the approval of the FDA prior to being made available to the public. The inability to fully characterize the active ingredients of the product leads many experts to believe that the only way to ensure the safety, efficacy and immunogenicity of any purported generic version of Copaxone would be through full-scale, placebo-controlled clinical trials with measured clinical endpoints in RRMS patients. The company is confident Copaxone will remain a proprietary, global market leading product for the reduction in the frequency of relapses in RRMS patients over the product’s lifecycle, given the strength of its intellectual property rights.
News For TEVA From The Last 14 Days
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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.
May 13, 2015
08:02 EDTTEVAANI Pharmaceuticals acquires rights to testosterone gel 1%
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May 11, 2015
14:27 EDTTEVACowen recommends adding to both Teva and Mylan at current levels
Cowen recommends adding to both Teva (TEVA) and Mylan (MYL) at current levels. The firm continues to believe that a Mylan transaction will proceed despite some early contentious language, and all of Mylan's concerns will be resolved.
11:53 EDTTEVATeva rejected chance to acquire Perrigo a few months ago, Globes reports
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May 10, 2015
19:25 EDTTEVACourt rejects claim that drugmakers misled opiate patients, Bloomberg says
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