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FDA Permits Marketing of Artificial Intelligence-Based Device to Detect Certain Diabetes-Related Eye Problems

The U.S. Food and Drug Administration today permitted marketing of the first medical device to use artificial intelligence to detect greater than a mild level of the eye disease diabetic retinopathy in adults who have diabetes. Diabetic retinopathy occurs when high levels of blood sugar lead to damage in the …

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FDA Approves Bydureon for Use with Basal Insulin in Patients with Type 2 Diabetes with Inadequate Glycemic Control

WILMINGTON, Del.–(BUSINESS WIRE)–AstraZeneca today announced the US Food and Drug Administration (FDA) has approved BYDUREON® (exenatide extended-release) for injectable suspension as an add-on therapy to basal insulin in adults with type 2 diabetes (T2D) with inadequate glycemic control. BYDUREON is approved for adults with T2D whose blood sugar remains uncontrolled on …

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FDA Approves Merck and Pfizer’s SGLT2 Drug for Treatment of Type 2 Diabetes

KENILWORTH, N.J. & NEW YORK–(BUSINESS WIRE)–Merck (NYSE:MRK), known as MSD outside the United States and Canada, and Pfizer Inc. (NYSE:PFE), today announced that the U.S. Food and Drug Administration (FDA) has approved STEGLATROTM(ertugliflozin) tablets, an oral sodium-glucose cotransporter 2 (SGLT2) inhibitor, and the fixed-dose combination STEGLUJAN™ (ertugliflozin and sitagliptin) tablets. …

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FDA Approves Sanofi’s Admelog, a Biosimilar of Humalog

PARIS, Dec. 11, 2017 /PRNewswire/ — The U.S. Food and Drug Administration (FDA) has approved Sanofi’s Admelog®, the first follow-on insulin lispro to help people living with diabetes manage blood sugar levels at mealtime. “Sanofi has a deep heritage and broad experience in providing treatments for people living with diabetes. Complementing our existing insulin …

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NYU Stern Study Shows Significant Health Improvement in Diabetes Patients with Mobile Health Applications

NEW YORK–(BUSINESS WIRE)–New research “Empowering Patients Using Smart Mobile Health Platforms: Evidence from a Randomized Field Experiment,” from NYU Stern Professor Anindya Ghose and co-authors, Beibei Li of Carnegie Mellon University and Xitong Guo of the Harbin Institute of Technology, explores how emerging mobile health (mHealth) technologies can persuade chronic-disease patients to …

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FDA Approves New Once-Weekly Bydureon BCise Injectable Medicine for Type 2 Diabetes

WILMINGTON, Del.–(BUSINESS WIRE)–AstraZeneca today announced that the US Food and Drug Administration (FDA) has approved BYDUREON® BCise™ (exenatide extended-release) injectable suspension, a new formulation of BYDUREON® (exenatide extended-release) injectable suspension in an improved once-weekly, single-dose autoinjector device for adults with type-2 diabetes whose blood sugar remains uncontrolled on one or more oral medicines …

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Merck’s Follow-On Biologic Basal Insulin Granted Tentative Approval from the FDA

KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE:MRK), known as MSD outside of the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has granted tentative approval for LUSDUNA™ Nexvue™ (insulin glargine injection) 100 units/mL, a follow-on biologic1 basal insulin in a pre-filled dosing device. LUSDUNA Nexvue is being developed …

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CDC Report Finds More than 100 Million Americans have Diabetes or Prediabetes

ATLANTA, July 18, 2017 /PRNewswire-USNewswire/ — More than 100 million U.S. adults are now living with diabetes or prediabetes, according to a new report released today by the Centers for Disease Control and Prevention (CDC). The report finds that as of 2015, 30.3 million Americans – 9.4 percent of the …

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Johnson & Johnson Innovation Announces New Collaborations Advancing Ground-Breaking Biomedical Innovation

NEW BRUNSWICK, N.J., June 15, 2017 /PRNewswire/ — Johnson & Johnson Innovation LLC today announced new collaborations that seek to develop potential treatments for diseases in urgent need of solutions, including obesity and related complications, such as type 2 diabetes and non-alcoholic steatohepatitis (NASH), and rheumatoid arthritis, and advance cutting-edge …

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Merck and Pfizer Announce Investigational SGLT-2 Inhibitor Met Primary Endpoint in Two Phase 3 Studies

KENILWORTH, N.J. & NEW YORK–(BUSINESS WIRE)–Merck (NYSE:MRK), known as MSD outside the United States and Canada, in partnership with Pfizer Inc. (NYSE:PFE), today announced that two Phase 3 studies (VERTIS MET and VERTIS SITA) of ertugliflozin, an investigational oral SGLT-2 inhibitor in development to help improve glycemic control in adults …

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