Clinical & Regulatory



Pluristem Therapeutics Inc.

Pluristem Therapeutics Inc. announced that the results from Fraunhofer Institute's additional pre-clinical study utilizing the Company's proprietary PLacental eXpanded (PLX) cells in treating ischemic stroke showed statistical significance utilizing functional as well as anatomical endpoints.

CV Therapeutics, Inc. and Astellas Pharma US Inc.

ATS Medical Inc.

ATS Medical Inc. announced the first North American commercial implant of the ATS 3f(R) Aortic Bioprosthesis. Canadian regulatory approval was received at the end of December, 2007.

Keryx Biopharmaceuticals Inc.

Keryx Biopharmaceuticals Inc. announced top-line results from its SUN-MICRO Phase 3 clinical trial of Sulonex (sulodexide) for the treatment of diabetic nephropathy.

Prometic Life Sciences Inc.

ProMetic Life Sciences Inc. announced favorable top-line findings from the third cohort in its Phase II trial with PBI-1402 in patients with chemotherapy-induced anemia. Analysis of the compiled data from a total of 18 patients showed an overall statistically significant increase of the mean hematocrit values at weeks 4, 6 and 8, and of the hemoglobin values at week 8. At week 8, p values were 0.02 for hematocrit and hemoglobin.

Keryx Biopharmaceuticals Inc.

Keryx Biopharmaceuticals Inc. announced top-line results from its SUN-MICRO Phase 3 clinical trial of Sulonex (sulodexide) for the treatment of diabetic nephropathy.

A simple urine test can help identify which patients might suffer kidney damage as a result of surgery

A simple urine test can help identify which patients might suffer kidney damage as a result of surgery - in some cases, up to three days before the damage would otherwise be detected, new research from Cincinnati Children's Hospital Medical Center shows.  Kidney failure is a very real risk for patients who undergo heart surgery, and local surgeons say they're enthused by the possibility of having a new tool to help manage patient care. 

Keryx Biopharmaceuticals Inc.

Keryx Biopharmaceuticals Inc. announced that following a Drug Safety and Monitoring Committee (DSMC) review of the SUN-MACRO Phase 4 trial of Sulonex(TM) (sulodexide oral gelcap), the Company has decided to terminate the study and cease further development of Sulonex.
 
Syndicate content