Specialty Pharma Journal Specialty, Precision & Technology
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 …
Tag Archives: diabetes
September, 2018
August, 2018
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17 August
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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3 August
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 …
June, 2018
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21 June
FDA Approves World’s First Long-Term Implantable Continuous Glucose Monitoring System for Patients with Diabetes
The U.S. Food and Drug Administration today approved the Eversense Continuous Glucose Monitoring (CGM) system for use in people 18 years of age and older with diabetes. This is the first FDA-approved CGM system to include a fully implantable sensor to detect glucose, which can be worn for up to …
April, 2018
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12 April
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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5 April
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 …
December, 2017
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22 December
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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13 December
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 …
November, 2017
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17 November
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 …
July, 2017
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21 July
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 …