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August 21, 2014
10:02 EDTSPPISpectrum weakness attributed to FDA comment on Fusilev generics
The move lower in shares of Spectrum is being attributed to circulation of a Department of Health and Human Services document which states the FDA will be able to approve abbreviated new drug applications for levoleucovorin calcium, the trade name of Spectrum's Fusilev. Shares of Spectrum are down 4%, or 33c, to $7.42. Reference Link
News For SPPI From The Last 14 Days
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November 20, 2015
07:02 EDTSPPISpectrum submits IND to FDA to initiate Phase 2 breast cancer study
Spectrum Pharmaceuticals announced today the company has submitted an IND application to the U.S. Food and Drug Administration and plans to initiate a Phase 2 breast cancer study in the U.S. as soon as possible. The Phase 2 study is planned to be an open-label study that will enroll approximately 70 patients with HER-2 positive metastatic breast cancer, who have failed at least one or more HER-2 directed therapy. The dose and schedule of oral poziotinib will be based on clinical experience from the studies in Korea, and in addition include the use of prophylactic therapies to help minimize known side-effects of HER2-directed therapies.
November 18, 2015
05:35 EDTSPPISpectrum divests rights to Zevalin in Japan, other countries
Spectrum Pharmaceuticals announced the divestment of Zevalin rights in Japan and other countries in Asia Pacific, Middle East, Africa and Latin America, to Mundipharma. Spectrum will receive an up-front payment of $15M plus $5M in profits on initial Zevalin supply. Spectrum will continue to own Zevalin rights for U.S., Canada, and Europe.

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