Cysview’s New Prefilled Syringe Packaging Gets FDA Approval August 12, 2016 The device is now a prefilled syringe in a kit without needles. Read More
AbbVie Takes Amgen to Court Over 10 Humira Patents August 12, 2016 Drugmaker contends Amgen’s biosimilar candidate infringes on 61 patents. Read More
Ascensia Launches Wireless Blood Glucose Monitoring System August 11, 2016 Device is designed to work with Medtronic’s MiniMed system. Read More
Novartis Drug Gets Props from NICE August 11, 2016 NICE recommends reimbursement of Novartis’ innovative drug Cosentyx. Read More
UK Sends Out Safety Alerts for Infant Warmers, Ventilators August 10, 2016 The infant-warmer poses a fire risk in skin temperature mode. Read More
Industry at Odds Over Biosimilar Interchangeability Labeling August 10, 2016 Interchangeability and biosimilarity statements would clarify differences. Read More
GSK, Verily Establish Bioelectronics Joint Venture August 9, 2016 GSK will hold a 55 percent equity interest and Verily will hold 45 percent. Read More
EMA’s Adaptive Pathway Pilot Hits Benchmark, Moves to Formalization August 9, 2016 New path allows real world evidence to supplement randomized clinical trials. Read More
InSeal Medical Gets CE Mark for Vascular Closure Device August 8, 2016 The device requires no pre-procedure. Read More
FDA Guidance Updates IRB Written Procedures August 8, 2016 The draft document takes into account variations in procedures. Read More
Vyriad Signs Exclusive License Agreement for STING Technology August 5, 2016 Vyriad will use this encoding for their device for the treatment of advanced cancer. Read More
EU Urged to Suspend License of Chinese API Maker August 5, 2016 Company has been in violation of GMP standards since June 2015. Read More