Shots: The US FDA has granted FTD for VX-880 to treat T1D. The designation is designed to facilitate the development and expedite the review of treatments for serious condition and […]readmore
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 […]readmore
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 […]readmore
Shots: The US FDA has expanded the label for Fiasp (insulin aspart injection, 100 u/mL) to be used in insulin infusion pumps for the improvement of glycemic control in adults […]readmore
Shots: Vertex acquires Semma Therapeutics, in all cash transaction making a total deal value $950M and Semma will operate as a subsidiary of Vertex. The transaction is expected to be […]readmore
Regulatory
AstraZeneca’s Forxiga (dapagliflozin) Receives MHLW’s Approval for Type-1 Diabetes (T1D)
Shots: The approval is based on P-III DEPICT & D1695C00001 study results assessing Forxiga (5/10 mg) vs PBO in patients with T1D inadequately controlled by insulin for 28 to 52 […]readmore
Shots: The approval is based on P-III two DEPICT study results DEPICT 1 (NCT02268214) & DEPICT 2 (NCT02460978) assessing Forxiga (5/10 mg) vs PBO in patients with T1D inadequately controlled […]readmore
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, […]readmore
Regulatory
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 […]readmore
Shots: Novo Nordisk’s Tresiba has received an approval for indication expansion by Health Canada for the treatment of pediatric patients (>2 years of age) with Type 1 diabetes The expanded […]readmore