Insulia wins FDA nod, CE Mark clearance to titrate Tresiba, Basaglar insulin
Voluntis said today that its digital management system for people with Type II diabetes, Insulia, won FDA clearance and CE Mark approval to integrate basal insulin brands Tresiba and Basaglar. The company’s software already works with Lantus, Toujeo and Levemir.
The Insulia digital companion is composed of a patient mobile app and healthcare worker web portal. The app gives real-time basal insulin dosing recommendations and educational coaching messages based on blood glucose levels to patients with Type II diabetes.
Get the full story at our sister site, Drug Delivery Business News.
The post Insulia wins FDA nod, CE Ma...
Source: Mass Device - November 16, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Diabetes Drug-Device Combinations Food & Drug Administration (FDA) Pharmaceuticals Regulatory/Compliance Wall Street Beat Voluntis Source Type: news
Sanofi files patent infringement suit against Mylan over insulin pen
Sanofi (NYSE:SNY) filed a patent infringement suit against Mylan (NSDQ:MYL) yesterday in the U.S. District Court of New Jersey, alleging that the EpiPen-maker infringed upon 18 patents covering Sanofi’s Lantus insulin glargine injection and SoloStar pen.
The suit was triggered by a notice from Mylan in mid-September, Sanofi said. Mylan told the insulin-maker that it had filed an NDA for an insulin glargine pre-filled pen, which challenged all of the patents listed for Sanofi’s Lantus products.
Get the full story at our sister site, Drug Delivery Business News.
The post Sanofi files patent infringement suit against...
Source: Mass Device - October 25, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Drug-Device Combinations Legal News Patent Infringement Pharmaceuticals Wall Street Beat Merck Mylan Sanofi-Aventis Source Type: news
Insulin Glargine/Breast Cancer Link Seen Again in Type 2 Diabetes Insulin Glargine/Breast Cancer Link Seen Again in Type 2 Diabetes
A study in more than 22,000 women reports a weak signal of breast-cancer risk with insulin glargine vs NPH insulin, but the researchers caution that this should not change clinical practice.Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - October 18, 2017 Category: Consumer Health News Tags: Diabetes & Endocrinology News Source Type: news
Soliqua Injection (Insulin Glargine and Lixisenatide) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - October 9, 2017 Category: Drugs & Pharmacology Source Type: news
Targeting Hypoglycemia and Glycemic Variability in T2D? More From DEVOTE Targeting Hypoglycemia and Glycemic Variability in T2D? More From DEVOTE
Secondary analyses from the DEVOTE trial comparing the ultralong-acting insulin degludec with insulin glargine examine associations between glycemic variability and severe hypoglycemia and outcomes.Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - September 15, 2017 Category: Consumer Health News Tags: Diabetes & Endocrinology News Source Type: news
More people treated with once-weekly semaglutide achieved reductions in both glucose and weight vs. comparator treatments
A post-hoc analysis of the SUSTAIN 1-5 trials demonstrated that a greater proportion of adults with type 2 diabetes achieved a clinically meaningful reduction in both HbA1c and body weight with once-weekly semaglutide vs. comparator treatments. Comparators included placebo, sitagliptin, insulin glargine U100 or exenatide extended release (ER). (Source: World Pharma News)
Source: World Pharma News - September 12, 2017 Category: Pharmaceuticals Tags: Featured Novo Nordisk Business and Industry Source Type: news
Sanofi brings another insulin glargine patent suit against Merck
Sanofi Aventis (NYSE:SNY) yesterday filed another patent lawsuit against Merck Sharp & Dohme Corp. (NYSE:MRK), alleging that Merck’s product infringes upon two patents covering Sanofi’s insulin glargine product, Lantus.
In July, Merck won tentative approval for its follow-on biologic version of Sanofi’s Lantus. The agency’s final regulatory nod is contingent upon the resolution of these patent infringement suits, according to Reuters.
Get the full story at our sister site, Drug Delivery Business News.
The post Sanofi brings another insulin glargine patent suit against Merck appeared first on Mas...
Source: Mass Device - August 9, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Diabetes Drug-Device Combinations Legal News Patent Infringement Pharmaceuticals Wall Street Beat Merck Sanofi-Aventis Source Type: news
Biosimilar insulin lispro shown not inferior to Humalog ® in efficacy or safety
(Mary Ann Liebert, Inc./Genetic Engineering News) A study comparing the safety and efficacy of SAR342434, a biosimilar (follow-on form) of insulin lispro-Humalog ® , found it to be comparable to that of the brand name drug in patients also using insulin glargine. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - August 9, 2017 Category: International Medicine & Public Health Source Type: news
EndoBreak: Steady Diabetes Rates; Lantus Copy Semi-Approved
(MedPage Today) -- News and commentary from the endocrinology world (Source: MedPage Today Public Health)
Source: MedPage Today Public Health - July 21, 2017 Category: American Health Source Type: news
Merck Announces U.S. FDA Grants Tentative Approval for Lusduna Nexvue (insulin glargine injection), a Follow-On Biologic Basal Insulin
KENILWORTH, N.J.--(BUSINESS WIRE) July 20, 2017 --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... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - July 20, 2017 Category: Drugs & Pharmacology Source Type: news
FDA tentatively approves Merck's copycat of Sanofi's Lantus
(Reuters) - Merck and Co Inc said on Thursday the U.S. Food and Drug Administration (FDA) tentatively approved its biosimilar version of French drugmaker Sanofi SA's blockbuster diabetes treatment, Lantus. (Source: Reuters: Health)
Source: Reuters: Health - July 20, 2017 Category: Consumer Health News Tags: healthNews Source Type: news
Lawsuit stalls approval of Merck ’ s insulin injection
Merck (NYSE:MRK) said today that the FDA granted tentative approval for its Lusduna Nexvue insulin glargine injection.
The biologic basal insulin met regulatory standards, the company said, but a patent infringement lawsuit initiated by competitor Sanofi (NYSE:SNY) in September of last year invoked an automatic delay for the drug-device combination product’s final approval.
Get the full story at our sister site, Drug Delivery Business News.
The post Lawsuit stalls approval of Merck’s insulin injection appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - July 20, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Diabetes Drug-Device Combinations Food & Drug Administration (FDA) Pharmaceuticals Regulatory/Compliance Wall Street Beat Merck Sanofi-Aventis Source Type: news
Voluntis wins regulatory nod to integrate Toujeo insulin with Insulia mobile app
Voluntis said today its digital management system for people with Type II diabetes, Insulia, won FDA clearance and CE Mark approval to integrate Sanofi‘s (NYSE:SNY) Toujeo insulin glargine. The company’s software already works with Lantus and Levemir.
The Insulia digital companion is composed of a patient mobile app and healthcare worker web portal. The app gives real-time basal insulin dosing recommendations and educational coaching messages based on blood glucose levels to patients with Type II diabetes. The web portal enables healthcare practitioners to develop personalized treatment plans and track their patient ...
Source: Mass Device - July 18, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Diabetes Drug-Device Combinations Food & Drug Administration (FDA) Health Information Technology Pharmaceuticals Regulatory/Compliance Software / IT Wall Street Beat Sanofi-Aventis Voluntis Source Type: news
Insulin Degludec Tied to Fewer Hypoglycemic Episodes Than Insulin Glargine (FREE)
By Kelly Young
Edited by David G. Fairchild, MD, MPH, and Lorenzo Di Francesco, MD, FACP, FHM
Insulin degludec is associated with lower hypoglycemia rates than insulin glargine U100 in patients with diabetes, according to two industry-funded studies in JAMA.Researchers enrolled roughly … (Source: Physician's First Watch current issue)
Source: Physician's First Watch current issue - July 5, 2017 Category: Primary Care Source Type: news
Novo Nordisk touts late-stage trial data for Tresiba insulin injection
Novo Nordisk (NYSE:NVO) touted data today from 2 Phase IIIb trials comparing Tresiba insulin degludec to insulin glargine in adults with Type I and Type II diabetes.
The results were published in the Journal of the American Medical Association.
The Switch trials are the 1st double-blinded insulin trials to compare the hypoglycemia rates and risks in patients using Tresiba and insulin glargine for Type I diabetes and Type II diabetes.
Get the full story at our sister site, Drug Delivery Business News.
The post Novo Nordisk touts late-stage trial data for Tresiba insulin injection appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - July 3, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Clinical Trials Diabetes Drug-Device Combinations Pharmaceuticals Wall Street Beat Novo Nordisk Source Type: news
