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News Breaks
February 21, 2014
07:50 EDTTEVATeva receives CHMP positive opinion for DuoResp Spiromax
Teva Pharmaceutical Industries announced that the European Medicines Agency's Committee for Medicinal Products for Human Use has issued a positive opinion recommending marketing authorization for DuoResp Spiromax inhalation powder for the treatment of patients with asthma and chronic obstructive pulmonary disease when a combination inhaled corticosteroid and long-acting beta2-adrenoceptor agonist is appropriate. This CHMP decision creates a path forward for a final approval decision from the European Commission that is expected in the next few months. In addition to the European application, applications will be made in a number of major countries worldwide.
News For TEVA From The Last 14 Days
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July 23, 2014
10:02 EDTTEVAOn The Fly: Analyst Initiation Summary
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08:10 EDTTEVADeutsche Bank hosts an analyst Specialty Pharma/Industry conference call
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July 22, 2014
16:08 EDTTEVATeva initiated with a Buy at Deutsche Bank
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July 21, 2014
08:11 EDTTEVAArena Pharma' subsidiary enters into agreement for Belviq with Teva subsidiary
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08:01 EDTTEVATeva completes acquisition of Labrys
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July 16, 2014
08:48 EDTTEVATeva says ISS supports company's nominees, shareholders' meeting proposals
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July 15, 2014
11:13 EDTTEVAPerrigo retreats after analyst sees limited potential buyers
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06:28 EDTTEVAActivist shareholder says Teva to appoint new chairman, Reuters says
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July 14, 2014
08:04 EDTTEVATeva announces FDA acceptance of NDA filing for albuterol MDPI
Teva Pharmaceuticals Industries announced that the U.S. Food and Drug Administration has accepted for review the company’s new drug application for albuterol multi-dose dry-powder inhaler, an investigational breath-actuated dry-powder inhaler for the treatment or prevention of bronchospasm in patients 12 years of age and older with reversible obstructive airway disease; and for the prevention of exercise-induced bronchospasm in patients 12 years of age and older. The NDA filing includes data from eight clinical studies that evaluated the safety and efficacy of albuterol MDPI in adults and adolescents with asthma and exercise-induced bronchospasm. The NDA for albuterol MDPI has been accepted by the FDA for standard review, with a FDA Regulatory Action expected in March 2015.
July 9, 2014
07:15 EDTTEVATeva, others fined $583.4M by EU regulators, Reuters says
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06:49 EDTTEVAGeneric drug prices have risen significantly, NY Times says
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