BiO2 Medical Gets FDA Nod to Start IDE Trial of Its Angel Catheter January 13, 2015 The trial will study the catheter’s ability to prevent pulmonary embolisms. Read More
NICE Updates Process for Reviewing Biosimilar Applications January 13, 2015 Applications for national coverage will be reviewed under a multiple technology appraisal process along with the reference product. Read More
Dako and Cell Signaling Technologies Partner on Cancer CDx January 12, 2015 The agreement calls for CST to provide Dako with antibodies. Read More
Janssen Commences Ebola Vaccine Trial in UK January 12, 2015 The company plans to commence larger trials in the U.S. and Africa this spring. Read More
PorOsteon Wins FDA Nod for Phusion Metal Cervical Cage January 9, 2015 The cage is designed to spur bone growth and mimic natural bone. Read More
OncoGenex Recoups Custirsen Rights from Teva January 9, 2015 The company is ending a five-year collaboration with the Israeli drugmaker. Read More
Celgene Incapable of Dismissing Lawsuit in First Written REMS Opinion January 9, 2015 A federal judge has denied Celgene’s motion to dismiss a lawsuit alleging it refused to provide product samples. Read More
SynCardia Gets FDA Nod to Study Temporary Artificial Heart as Total Replacement January 8, 2015 The Total Artificial Heart is currently approved as a bridge to a donor transplant. Read More
Vertex’s Kalydeco Gets Additional FDA Approval for Cystic Fibrosis January 8, 2015 It can now be used to treat patients six years and older with at least one copy of the R117H gene mutation. Read More
BioMonde Launches BioBag Debridement Product in U.S. January 7, 2015 The noninvasive product quickly treats stubborn wounds such as ulcers. Read More
FDA Approves Novo Nordisk’s Weight Loss Drug Saxenda January 7, 2015 The drug is meant to be used in addition to low-calorie diet and exercise. Read More
Stereotaxis Gets FDA Green Light for Catheter-Guiding Product January 6, 2015 The V drive with V-CAS is the third in the company’s remote-controlled portfolio. Read More