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Press Releases

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Oct 26, 2015
Company on Track for Apaziquone NDA Filing Based on Prior Phase 3 Data by Year End Learnings From Prior Trials and Agreement with the FDA Through a Special Protocol Assessment (SPA) Incorporated into Study Design Pivotal Study Would Satisfy FDA's Requirement of Initiating an Additional Phase 3
Oct 23, 2015
The FDA did not identify any clinical deficiency in the CRL Company plans to meet with FDA and seek clarification on the CRL HENDERSON, Nev. --(BUSINESS WIRE)-- Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a
Sep 03, 2015
HENDERSON, Nev. --(BUSINESS WIRE)-- Spectrum Pharmaceuticals (NasdaqGS: SPPI) , a biotechnology company with fully integrated commercial and drug development operations with a primary focus in Hematology and Oncology, today announced that an overview of the Company's business strategy and
Sep 02, 2015
Published Data Highlights Achievement of Myeloablation (Median Day 5) and Engraftment (Median Day 12-13) with no mortality (Day 100) EVOMELA is Free of Propylene Glycol, a Diluent Required for Reconstitution of Current Melphalan Formulations that is Associated with Renal and Cardiac Toxicities
Aug 17, 2015
Company is on Track for Apaziquone NDA Filing by Year End Based on Pooled Data from Two Completed Phase 3 Studies that Showed a Statistically Significant Reduction in 2-Year Recurrence Rates (p-value = 0.0218) Learnings From Earlier Phase 3 Program and FDA's Comments Incorporated in New Phase 3
Aug 06, 2015
SPI-2012 : Pursuing Special Protocol Assessment (SPA) before initiating a non-inferiority Phase 3 study, also powered at 80% for superiority to pegfilgrastim EVOMELA ™ (melphalan hydrochloride) for injection: On track for FDA decision (NDA PDUFA date of October 23, 2015 ) Poziotinib : Expect to
Jul 30, 2015
HENDERSON, Nev. --(BUSINESS WIRE)-- Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, today announced it will host a teleconference and webcast with management to
Jun 24, 2015
Beleodaq is marketed in the U.S. by Spectrum Pharmaceuticals, Inc. HENDERSON, Nev. --(BUSINESS WIRE)-- Spectrum Pharmaceuticals (NasdaqGS: SPPI) , a biotechnology company with fully integrated commercial and drug development operations with a primary focus in Hematology and Oncology, announced
May 29, 2015
HENDERSON, Nev. --(BUSINESS WIRE)-- Spectrum Pharmaceuticals, Inc. (Nasdaq: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in Hematology and Oncology, today announced presentations of clinical data for Beleodaq ® (belinostat),
May 28, 2015
HENDERSON, Nev. --(BUSINESS WIRE)-- Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in Hematology and Oncology, today announced that an overview of the Company's business strategy and
May 14, 2015
HENDERSON, Nev. --(BUSINESS WIRE)-- Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, today commented on the recent filing by Armistice Capital LLC ("Armistice"),
May 07, 2015
Significant Progress in Q1 on Two Potential Blockbusters and Two Near-term NDA's SPI-2012, a novel long-acting GCSF: Positive Phase 2 data presented at Analyst Day, and final Phase 3 protocols have been sent to the FDA Poziotinib, a novel pan-HER inhibitor: Compelling Phase 1 data presented in
Apr 30, 2015
HENDERSON, Nev. --(BUSINESS WIRE)-- Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, today announced it will host a teleconference and webcast with management to
Mar 30, 2015
EVOMELA stability shown to be significantly longer than current Melphalan HCl for Injection in an oral presentation at the annual American Pharmacists Association (APhA) meeting. The increased stability of EVOMELA allows a longer use time, and could importantly simplify clinical administration
Mar 13, 2015
Development Highlights: 2 Near-term NDA's and 2 Potential Blockbusters SPI-2012 , a novel long-acting GCSF, demonstrated non-inferiority to pegfilgrastim at the 135 µg/kg dose (p= 0.002), and superiority at the 270 µg/kg dose (p= 0.023) in a randomized Phase 2 Study.
Mar 11, 2015
HENDERSON, Nev. --(BUSINESS WIRE)-- Spectrum Pharmaceuticals (NasdaqGS: SPPI) , a biotechnology company with fully integrated commercial and drug development operations with a primary focus in Hematology and Oncology, will be hosting its fourth quarter 2014 financial results and analyst day in New
Mar 09, 2015
PDUFA decision expected October 23, 2015 , 10 months from NDA filing. Approval is being sought for use as a high-dose conditioning treatment prior to stem cell transplantation in multiple myeloma and for the palliative treatment of patients with multiple myeloma for whom oral therapy is not
Mar 04, 2015
Poziotinib is a novel oral, pan-HER inhibitor that has shown single agent clinical activity in breast cancer, gastric cancer, lung cancer, and colorectal cancer, and is currently being studied in several Phase 2 clinical trials. Poziotinib has shown a remarkable 60% response rate in early clinical
Feb 20, 2015
HENDERSON, Nev. --(BUSINESS WIRE)-- Spectrum Pharmaceuticals (NasdaqGS: SPPI) , a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, today announced that an overview of the Company's business strategy and
Feb 17, 2015
HENDERSON, Nev. --(BUSINESS WIRE)-- Spectrum Pharmaceuticals (NasdaqGS: SPPI) , a biotechnology company with fully integrated commercial and drug development operations with a primary focus in Hematology and Oncology, today announced it will be hosting its fourth quarter 2014 financial results and
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