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Farxiga Study Showed Reduced Progression of Kidney Disease or Renal Death in Patients with Type 2 Diabetes

WILMINGTON, Del.–(BUSINESS WIRE)–A pre-specified exploratory analysis of renal data from the Phase III DECLARE-TIMI 58 trial, the broadest cardiovascular outcomes trial of a sodium-glucose co-transporter 2 (SGLT2) inhibitor, showed that FARXIGA (dapagliflozin) reduced the progression of kidney disease or renal death in patients with type 2 diabetes (T2D). These data, presented …

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FDA Grants Priority Review to Invokana sNDA for Treatment of Chronic Kidney Disease Patients with Type 2 Diabetes

RARITAN, N.J., May 22, 2019 /PRNewswire/ — The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) has granted Priority Review for the supplemental New Drug Application (sNDA) for INVOKANA® (canagliflozin) to reduce the risk of end-stage kidney disease (ESKD), the doubling …

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Victoza Demonstrated Superiority in Reducing Blood Sugar vs Placebo in Children and Adolescents with Type 2 Diabetes

BALTIMORE, April 28, 2019 /PRNewswire/ — Novo Nordisk today announced the results from the ELLIPSE trial which examined efficacy and safety and demonstrated superiority of Victoza® (liraglutide) injection 1.8 mg vs placebo in reducing blood sugar in children and adolescents aged 10-17 with type 2 diabetes.1 ELLIPSE is the first …

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Pfizer Exercises Option to License AnTolRx’s Immune Tolerance Therapy for Treatment of Type 1 Diabetes

CAMBRIDGE, Mass., March 5, 2019 /PRNewswire/ — AnTolRx, Inc., a private biotechnology company and a leader in immune tolerance, today announced that Pfizer Inc. (NYSE: PFE) has exercised the option granted under a June 2016 agreement to license an immune tolerance therapy from AnTolRx’s Type 1 diabetes research program. The …

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Medtronic Receives FDA Breakthrough Designation for Developing Personalized Closed Loop Insulin Pump System for Diabetes Management

DUBLIN – February 19, 2019 – Medtronic plc (NYSE:MDT), the global leader in medical technology, today announced it has received Breakthrough Device designation from the U.S. Food and Drug Administration (FDA) for its Personalized Closed Loop (PCL) insulin pump system, currently in development. The PCL technology is designed to automate insulin …

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FDA Committee Votes in Favor of Approving Zynquista, an Investigational Dual SGLT1 and SGLT2 Inhibitor, as Treatment for Type 1 Diabetes

PARIS and THE WOODLANDS, TX – January 17, 2019 – The Endocrinologic and Metabolic Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) today voted eight to eight on the question of whether the overall benefits of Zynquista(TM)* (sotagliflozin) outweighed the risks to support approval. Sotagliflozin is an investigational oral …

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FDA to Review Regeneron’s sBLA of Eylea Injection for the Treatment of Diabetic Retinopathy

TARRYTOWN, N.Y., Sept. 13, 2018 /PRNewswire/ — Regeneron Pharmaceuticals, Inc.(NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the supplemental Biologics License Application (sBLA) of EYLEA®(aflibercept) Injection for the treatment of diabetic retinopathy (DR), the leading cause of vision loss for patients with diabetes. The target action …

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Merck and Healthy Interactions Launch Digital Health Platform Designed to Enhance Patient Engagement in Diabetes Management

KENILWORTH, N.J., Aug. 17, 2018 /PRNewswire/ — Healthy Interactions, a global leader in health education, in collaboration with Merck (NYSE : MRK ), known as MSD outside the United States and Canada, today announced the launch of map4health™ – a digital platform and mobile application in the U.S. that was …

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Novo Nordisk Acquires Ziylo, Gaining Innovative Technology Platform that Could Accelerate Development of New Diabetes Treatment

BRISTOL and COPENHAGEN, 17 August 2018 ­- Ziylo and Novo Nordisk A/S today announced that Novo Nordisk has acquired all of the shares of Ziylo, a University of Bristol spin-out company based at Unit DX science incubator in Bristol, UK. Ziylo has been pioneering the use of its platform technology – …

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PDL BioPharma Acquires Depomed’s Remaining 50% Interest in Royalties and Milestones on Type 2 Diabetes Products

INCLINE VILLAGE, Nev., Aug. 2, 2018 /PRNewswire/ — PDL BioPharma, Inc. (“PDL”) (NASDAQ: PDLI) announces an amendment to the Royalty Purchase and Sale Agreement (the “Royalty Agreement”) with Depomed, Inc. (“Depomed”) under which PDL acquired all of Depomed’s remaining rights to royalties and milestones payable on sales of type 2 diabetes products licensed by Depomed for up to $20 million.  Under …

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