Tags : Type 1 Diabetes

MedTech Regulatory

Medtronic’s MiniMed 770G Insulin Pump System with Smartphone Connectivity Receives

Shots: The US FDA has approved MiniMed 770G hybrid closed loop system, offering SmartGuard technology, with smartphone connectivity and an expanded age indication to children aged ≤2yrs., making it easier to access and share real-time CGM and pump data The system will enable caregivers to analyze data remotely on their smartphones, with proactive in-app notices […]Read More


Medtronic Receives CE Mark for MiniMed 780G Insulin Pump to

Shots: Medtronic has received CE Mark for its MiniMed 780G system, a closed-loop insulin pump designed to treat T1D patients aged 7-80 yrs. The system utilizes SmartGuard algorithm and stabilizes blood sugar levels and further improves glucose control The MiniMed 780G system enables the personalization of glucose goals with an adjustable target setting as low […]Read More


Pfizer Exercised its Option to License AnTolRx’s Immune Tolerance Therapy

Shots: Pfizer to get exclusive rights for development and commercialization of AnTolRx’s lead immunotherapeutic for T1D. AnTolRx to receive upfront, milestones & royalties on sales Under the June 2016 agreement, Pfizer exercised its option to license AnTolRx’s T1D candidate AnTolRx develops antigen-specific therapies, based on immune tolerance induction, for inflammatory and autoimmune diseases including T1D, […]Read More


Sanofi’s Zynquista (sotagliflozin) and Dupixent (dupilumab) Receives CHMP Recommendation for

Shots: Zynquista’s CHMP recommendation is based on P-III TANDEM study assessing Zynquista (200mg &400mg) vs insulin in 3,000 patients with T1D mellitus. The study resulted in reduction in blood sugar level and systolic BP @24wks. & improvement in time to maintain targeted blood sugar range Dupixent ‘s CHMP recommendation is based on P-III QUEST and […]Read More