2017-10-18 08:00 ET - PCM-075 enhances activity of abiraterone in mCRPC tumors cells and may represent a novel treatment option to extend the benefit of anti-androgen therapy

 

SAN DIEGO, Oct. 18, 2017 -- Trovagene, Inc. (NASDAQ: TROV), a precision medicine biotechnology company, today announced positive data from preclinical research demonstrating synergy of PCM-075, its oral, highly-selective Polo-like Kinase 1 (PLK1) Inhibitor, in combination with abiraterone (Zytiga® - Johnson & Johnson). Abiraterone is a potent and irreversible inhibitor of CYP17, a critical enzyme in androgen biosynthesis and is indicated for the treatment of mCRPC in combination with prednisone. This research was performed in collaboration with a major cancer research institution.

PARIS --  Regulatory News:

Ipsen (Euronext: IPN; ADR: IPSEY) and its partner Exelixis (NASDAQ: EXEL) today announced that its global phase 3 CELESTIAL trial met its primary endpoint of overall survival (OS), with cabozantinib providing a statistically significant and clinically meaningful improvement in median OS compared to placebo in patients with advanced hepatocellular carcinoma (HCC). The independent data monitoring committee for the study recommended that the trial should be stopped for efficacy following review of the second planned interim analysis. CELESTIAL is a randomized, global phase 3 trial of cabozantinib versus placebo in patients with advanced HCC who have been previously treated with sorafenib. The safety data in the study were consistent with the established profile of cabozantinib.

LAVAL, QC, Oct. 13, 2017 - Prescription Drug User Fee Act (PDUFA) action date is set for April 14, 2018

Ryplazim™ previously granted Fast Track, Rare Pediatric Disease and Orphan Drug Designations by U.S. FDA

 

LAVAL, QC, Oct. 13, 2017 - Prometic Life Sciences Inc. (TSX: PLI) (OTCQX: PFSCF) (Prometic) today announced that the U.S Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) for its plasminogen replacement therapy (RyplazimTM) having  granted a priority review status and set a Prescription Drug User Fee Act (PDUFA) action date for April 14, 2018,  Ryplazim™ had previously been granted Fast Track, Orphan Drug and Rare Pediatric Disease designations by the U.S. FDA.

2017-10-13 08:30 ET - SEATTLE, Oct. 13, 2017  -- PhaseRx, Inc. (NASDAQ: PZRX), a biopharmaceutical company developing mRNA treatments for life-threatening inherited liver diseases in children, today announced that its board of directors has made a determination to conduct a restructuring of operations to reduce short term operating costs and delay the development of its lead product candidate PRX-OTC. This reorganization includes a reduction in PhaseRx's workforce by 10 employees, including some executive officers. These efforts are aimed at preserving the company's cash resources. As of June 30, 2017, PhaseRx had cash and equivalents of $8.4 million and a total of 20 employees.