19:48 , Aug 4, 2017 |  BC Week In Review  |  Clinical News

FDA approves Jazz's Vyxeos for AML

FDA approved Vyxeos (CPX-351) from Jazz Pharmaceuticals plc (NASDAQ:JAZZ) to treat adults with 2 types of acute myelogenous leukemia (AML) -- newly diagnosed therapy-related AML (t-AML) and AML with myelodysplasia-related changes (AML-MRC). On Aug. 3,...
07:16 , Jul 29, 2017 |  BioCentury  |  Finance

Show us your shorts

Absent any data showing a sustained impact of manipulative short selling on biotech valuations or their ability to raise capital, it is difficult to discern what direct benefit biotech companies would gain from BIO ’s...
16:03 , Jun 2, 2017 |  BC Week In Review  |  Clinical News

FDA grants Priority Review to NDA for Jazz’s Vyxeos

Jazz Pharmaceuticals plc (NASDAQ:JAZZ) said FDA accepted and granted Priority Review to an NDA for Vyxeos (CPX-351) to treat acute myelogenous leukemia (AML). Its PDUFA date is Sept. 30. Jazz completed its rolling NDA submission...
20:18 , Jun 1, 2017 |  BC Extra  |  Company News

Jazz's Vyxeos under Priority Review for AML

Jazz Pharmaceuticals plc (NASDAQ:JAZZ) said FDA accepted and granted Priority Review to its NDA for Vyxeos (CPX-351) to treat acute myelogenous leukemia (AML). Spokesperson Jacqueline Kirby told BioCentury its PDUFA date is Sept. 30. Vyxeos...
19:44 , Apr 14, 2017 |  BC Week In Review  |  Clinical News

Vyxeos regulatory update

Jazz completed submission of a rolling NDA to FDA and requested Priority Review for Vyxeos to treat acute myelogenous leukemia (AML). The product, a liposomal formulation of cytarabine and daunorubicin encapsulated at a 5:1 molar...
04:24 , Dec 10, 2016 |  BioCentury  |  Product Development

AML advances

Treatment paradigms in most cancers have followed a predictable if sometimes slow progression from chemotherapy, to agents that target features prevalent among a classically defined cancer type, to personalized approaches targeting features specific to an...
07:00 , Oct 10, 2016 |  BC Week In Review  |  Clinical News

Vyxeos regulatory update

Jazz Pharmaceuticals plc (NASDAQ:JAZZ), Dublin, Ireland   Product: Vyxeos ( CPX-351 )   Business: Cancer   Jazz began submission of a rolling NDA to FDA for Vyxeos to treat acute myelogenous leukemia (AML). The company...
07:00 , Oct 3, 2016 |  BC Extra  |  Company News

Jazz begins Vyxeos NDA submission

Jazz Pharmaceuticals plc (NASDAQ:JAZZ) started submitting a rolling NDA to FDA for Vyxeos ( CPX-351 ) to treat acute myeloid leukemia (AML). The company expects to complete the submission in early 2017, and said it...
07:00 , Jul 11, 2016 |  BioCentury  |  Finance

Rethinking risk

Steve Edelson, Senior Editor   The second half does not contain the high-impact, sector-moving milestones seen in the first six months of the year, but investors still have at least 90 late-stage milestones from which...
07:00 , Jul 11, 2016 |  BioCentury  |  Finance

Shedding red

Steve Edelson, Senior Editor   Brexit nearly wiped out what looked to be a rebound quarter for biotech. Only two market cap segments finished in positive territory, and smaller companies continued to get pounded. Big...