BioCentury | Dec 12, 2019
Company News

Dec. 11 Company Quick Takes: Kite, Alkermes, argenx, Reblozyl, Denovo-Sunesis

...Janssen" ). Denovo licenses AML therapy from Sunesis Denovo Biopharma LLC gained global rights to vosaroxin...
BioCentury | May 11, 2017
Clinical News

Sunesis withdraws vosaroxin MAA for AML

...Sunesis Pharmaceuticals Inc. (NASDAQ:SNSS) said it will withdraw an MAA from EMA for Qinprezo vosaroxin (AG-7352...
...and inhibits topoisomerase II (TOP2) . Sunesis has exclusive, worldwide rights to develop and commercialize Qinprezo...
...Dainippon Pharma Co. Ltd. (Tokyo:4506), Osaka, Japan Product: Qinprezo vosaroxin (AG-7352) (formerly SNS-595) Business: Cancer Alicia Parker AG-7352 Qinprezo vosaroxin Sumitomo...
BioCentury | Mar 31, 2017
Clinical News

Qinprezo regulatory update

...Sunesis submitted responses to Day 180 questions from EMA’s CHMP regarding an MAA for Qinprezo vosaroxin...
...disclose the agency's concerns or questions, but said it expects a CHMP decision by mid-year. Vosaroxin...
...Dainippon Pharma Co. Ltd. (Tokyo:4506), Osaka, Japan Product: Qinprezo vosaroxin (AG-7352) (formerly SNS-595) Business: Cancer Nora Weintraub Qinprezo vosaroxin Sumitomo...
BioCentury | Jan 11, 2016
Clinical News

Qinprezo vosaroxin regulatory update

...EMA accepted for review an MAA from Sunesis for Qinprezo vosaroxin to treat relapsed acute myelogenous...
...TOP2) . In July, Sunesis said FDA “did not support” submission of an NDA for Qinprezo...
...Sunesis Pharmaceuticals Inc. (NASDAQ:SNSS), South San Francisco, Calif. Product: Qinprezo vosaroxin ( AG-7352 ) (formerly SNS-595...
BioCentury | Jan 4, 2016
Company News

Clinigen Group, Sunesis sales and marketing update

...Idis Managed Access division partnered with Sunesis to manage a compassionate use program for Qinprezo vosaroxin...
BioCentury | Dec 14, 2015
Clinical News

Qinprezo vosaroxin: Pilot trial started

...Sunesis said investigators began an open-label, U.S. pilot trial to evaluate IV vosaroxin on days 1...
...treatments in about 17 previously untreated patients ages >=60. Patients will receive 90 mg/m 2 vosaroxin...
...Sunesis Pharmaceuticals Inc. (NASDAQ:SNSS), South San Francisco, Calif. Product: Qinprezo vosaroxin ( AG-7352 ) (formerly SNS-595...
BioCentury | Dec 14, 2015
Clinical News

Qinprezo vosaroxin regulatory update

...Sunesis submitted an MAA to EMA for Qinprezo vosaroxin to treat relapsed/refractory acute myelogenous leukemia (AML...
...TOP2) . In July, Sunesis said FDA “did not support” submission of an NDA for Qinprezo...
...Sunesis Pharmaceuticals Inc. (NASDAQ:SNSS), South San Francisco, Calif. Product: Qinprezo vosaroxin ( AG-7352 ) (formerly SNS-595...
BioCentury | Nov 23, 2015
Clinical News

Qinprezo vosaroxin: Additional Phase Ib/II data

...untreated AML or high-risk MDS in an open-label, U.S. Phase Ib/II trial showed that IV Qinprezo...
...28, 2014). In July, Sunesis said FDA “did not support” submission of an NDA for Qinprezo...
...Inc. (NASDAQ:SNSS), South San Francisco, Calif. Product: Qinprezo vosaroxin ( AG-7352 ) (formerly voreloxin , SNS-595...
BioCentury | Nov 23, 2015
Clinical News

Qinprezo vosaroxin: Phase I data

...with MDS in an open-label, U.S. Phase I trial showed that the MTD of IV Qinprezo...
...for <=6 cycles was 34 mg/m 2. At the initial dose of 50 mg/m 2 Qinprezo...
...Inc. (NASDAQ:SNSS), South San Francisco, Calif. Product: Qinprezo vosaroxin ( AG-7352 ) (formerly voreloxin , SNS-595...
BioCentury | Jul 27, 2015
Clinical News

Qinprezo regulatory update

...Sunesis said FDA “did not support” submission of an NDA for Qinprezo vosaroxin to treat acute...
...without additional clinical evidence. The company said it is committed to getting U.S. approval for Qinprezo...
...South San Francisco, Calif. Product: Qinprezo ( vosaroxin ) ( AG-7352 ) (formerly voreloxin , SNS-595...
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