FDA Greenlights Novo Nordisk’s Rebinyn, TEVA’s HALO Shines, LUCY Walks The Talk

Today’s Daily Dose brings you news about Cytori’s new BARDA contract option; Endologix’s encouraging data from post-market registry study of Ovation Platform; Exactech’s progress with its new Truliant Knee System; Jazz Pharma’s upcoming catalyst related to acute myeloid leukemia drug candidate VYXEOS; MannKind’s distribution agreement for the commercialization of inhaled insulin Afrezza in Brazil; Novo Nordisk’s approval of Hemophilia B treatment and Teva’s HALO study data.

Read on…

Cytori Therapeutics Inc. (CYTX) and the Biomedical Advanced Research and Development Authority, or BARDA, have executed a contract option valued at approximately $13.4 million.

The present option increases the overall BARDA commitment to Cytori technology to approximately $34.6 million thus far.

A U.S. pilot clinical trial of Cytori Cell Therapy in thermal burn injury, dubbed RELIEF, is expected to be initiated in Q4, 2017. The RELIEF trial will be funded by the new BARDA contract option.

CYTX closed Wednesday’s trading at $1.00, up 2.04%.

Endologix Inc. (ELGX) has reported encouraging 30-day data from LUCY study, its post-market registry study evaluating Ovation Abdominal Stent Graft Platform for the endovascular treatment of Abdominal Aortic Aneurysm in women.

The Ovation Abdominal Stent Graft System received FDA approval in November 2012.

The post-market registry study, LUCY, enrolled a total of 225 patients, including 76 females in the treatment group and 149 males in the control group, at 39 sites in the U.S. The primary endpoint of the study was the 30-day Major Adverse Event (“MAE”) rate.

The 30-daya data showed that at least 28% more women became eligible for minimally-invasive endovascular aneurysm repair (EVAR) when using the Ovation Abdominal Stent Graft System. The rate of MAE was 1.3%, the lowest rate reported for EVAR, compared to other contemporary, prospective, post-market registries. No deaths were reported in the registry study.

Longer-term data from the LUCY study will be…

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