Company Overview of Pinnacle Biologics, Inc.
Pinnacle Biologics, Inc., a biopharmaceutical research and development company, develops and manufactures healthcare therapies for oncology and rare diseases. It specializes in revitalizing older brands and enabling newer therapies to maximize their potential for development as orphan drugs to treat cancer indications, in addition to those for which they have previously been approved. The company offers PHOTOFRIN (porfimer sodium), a photodynamic therapy drug that is indicated for the palliation of patients with obstructing esophageal cancer; the treatment of microinvasive endobronchial non-small-cell lung cancer; and the ablation of high-grade dysplasia in Barrett’s esophagus patients who d...
2801 Lakeside Drive
Bannockburn, IL 60015
Founded in 2007
Key Executives for Pinnacle Biologics, Inc.
Vice-President of PDT Business Unit-Us
Compensation as of Fiscal Year 2014.
Pinnacle Biologics, Inc. Key Developments
FDA Approves Optiguide DCYL700 Fiber Optic Diffuser Series Flexible Fiber of Pinnacle Biologics, Inc
Mar 26 14
Concordia Healthcare Corp. announced that its subsidiary Pinnacle Biologics, Inc. was granted U.S. Food and Drug Administration (FDA) premarket supplemental approval (PMA) for its Optiguide DCYL700 Fiber Optic Diffuser Series flexible fiber. The Optiguide DCYL700 Fiber Optic Diffuser Series is a light delivery system used in Photodynamic Therapy (PDT) with PHOTOFRIN (porfimer sodium) approved for use in the treatment of non-small cell lung cancer (NSCLC) and esophageal cancer. The system features a more flexible, narrower cylindrical diffuser design that may assist physicians by providing greater access to tumors located in the right upper lobe of the lung and by improving maneuverability in other potentially challenging anatomic areas of the bronchus.
Pinnacle Biologics, Inc. Reaches Agreement with U.S. Food and Drug Administration under Special Protocol Assessment for Phase 3 Clinical Trial on New Therapy to Treat Perihilar Cholangiocarcinoma
Jan 13 14
Concordia Healthcare Corp. announced that its subsidiary Pinnacle Biologics, Inc. has reached an agreement with the U.S. Food and Drug Administration (the 'FDA') under a special protocol assessment (the 'SPA') to enroll patients with an advanced form of bile duct cancer in a pivotal Phase 3 clinical trial. There is currently no approved therapy for this cancer type. The SPA is a written agreement between Pinnacle and the FDA regarding the design, endpoints and planned statistical analysis approach of the trial to be used in support of a potential New Drug Application submission. The clinical trial will study the efficacy and safety of photodynamic therapy ('PDT') with PHOTOFRIN(R) (porfimer sodium) for injection as treatment for unresectable advanced perihilar cholangiocarcinoma (CCA) Bismuth type III/IV.
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