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PharmExec, 08/07/09
Did you know that, despite the industry's best efforts, more than 40% of the proposed brand names submitted to FDA and EMEA are rejected? Securing regulatory approval for a new brand name is often a difficult hurdle for companies to overcome.
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Novartis receives approval in the European Union for Onbrez Breezhaler, a new once-daily bronchodilator for patients with COPD
Novartis, 12/04/09
Safety concerns slow new drug review and approval processes
Formulary , 12/02/09
Teva Announces The Submission Of A Biologics License Application (BLA) For XM02 For The Treatment Of Chemotherapy-Induced Neutropenia
Teva Pharmaceutical Industries, 12/02/09
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