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December 10, 2013
07:04 EDTSPPISpectrum announces Belinostat New Drug Application submission
Spectrum announced the that the company has submitted a New Drug Application to the U.S. Food and Drug Administration for approval of Belinostat for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma. Response from the FDA regarding acceptance to file is expected within 60 days from the FDA receipt date. Over 1K patients have been exposed to belinostat across the development program that included 14 Sponsor-initiated studies and 16 additional NCI or investigator sponsored studies in various indications. The company said, "Based on the clinical data, belinostat was shown to have an acceptable safety profile and clinical efficacy, with complete responses in heavily pretreated patients. In June, data was presented which demonstrated the clinical activity of belinostat in treating patients with R/R PTCL with an overall response rate of 26% in these heavily pretreated patients that included patients who had received a previous allogeneic or autologous stem cell transplant.”
News For SPPI From The Last 14 Days
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April 23, 2014
07:13 EDTSPPILigand's partner Spectrum says Captisol-enabled melphalan meets primary endpoint
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07:10 EDTSPPISpectrum announces CE Melphalan trial met primary end points
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April 21, 2014
07:05 EDTSPPISpectrum promotes Turgeon to president, COO
Spectrum announced the promotion of Joseph Turgeon to president and COO. Turgeon was previously senior vice president and Chief Commercial Officer. Spectrum also announced the promotion of Thomas Riga to senior vice president, Chief Commercial Officer. Riga was previously vice president, corporate accounts. Ken Keller resigned as executive vice president, COO of the company to pursue other opportunities.
April 17, 2014
17:08 EDTSPPISpectrum names Joseph Turgeon COO
Spectrum disclosed in a regulatory filing that effective April 17, Spectrum Pharmaceuticals appointed Joseph Turgeon as its President and COO. Mr. Turgeon will have global responsibility for leading Commercial Operations, Medical and Clinical Development and Pharmaceutical Operations. On April 17, Ken Keller resigned from his position as EVP and COO of the company in order to assume the role of CEO of an organization on the east coast. Mr. Keller will continue to be employed by the company through April 28 in order to assist with the transition. Keller’s resignation was not the result of any disagreement with the company on any matter relating to the company’s operations, policies or practices.

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