Shots: The company completes two P-III studies that compares proposed biosimilar Gan & Lee insulin glargine (GL-GLA) to a reference biologic n subjects with type 1 (n=576) and type 2 […]readmore
Tags : T1D
Shots: The BLA for teplizumab to delay or prevention of clinical T1D in at-risk individuals has been filed to the US FDA. The FDA has also granted Provention’s request for […]readmore
Shots: The US FDA’s Endocrinologic and Metabolic Drugs Advisory Committee has voted (2 out of 14) against the use of Empagliflozin 2.5 mg as an add-on to insulin therapy in […]readmore
Shots: Medtronic reports that it has secured for its reimbursement for the MiniMed 670G insulin pump system with the German Federal Association of the Statutory Health Insurances (GKV-SV). The reimbursement […]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