Tresiba ® demonstrated no increased risk of major cardiovascular events and significant reduction in rates of severe hypoglycaemia compared to insulin glargine U100 in the DEVOTE trial
Novo Nordisk has announced the primary results from DEVOTE - the first randomised, double-blind, treat-to-target, event-driven trial comparing two basal insulins, Tresiba® (insulin degludec injection 100 U/mL) and insulin glargine U100, in adults with type 2 diabetes at high risk of cardiovascular (CV) disease. (Source: World Pharma News)
Source: World Pharma News - June 15, 2017 Category: Pharmaceuticals Tags: Featured Novo Nordisk Business and Industry Source Type: news
Novo Nordisk seeks to include cardiovascular data in Tresiba insulin label
Novo Nordisk (NYSE:NVO) said today that it submitted a supplemental application to the FDA, asking to include cardiovascular data on the label of its Tresiba insulin degludec.
The Danish insulin-maker asked to include data specifically from the Devote trial, which evaluated the cardiovascular safety of Tresiba compared to insulin glargine in patients with Type II diabetes.
Get the full story at our sister site, Drug Delivery Business News.
The post Novo Nordisk seeks to include cardiovascular data in Tresiba insulin label appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - May 30, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Cardiovascular Clinical Trials Diabetes Drug-Device Combinations Food & Drug Administration (FDA) Pharmaceuticals Regulatory/Compliance Wall Street Beat Novo Nordisk Source Type: news
High-Strength Insulin Glargine Reduces Hypoglycemic Events in T2D
(MedPage Today) -- Retrospective study of real-world basal insulin use (Source: MedPage Today Cardiovascular)
Source: MedPage Today Cardiovascular - April 5, 2017 Category: Cardiology Source Type: news
Sanofi boasts observational hypoglycemia rates for Toujeo insulin injection
Sanofi (NYSE:SNY) touted real-world clinical data for its Toujeo insulin glargine injection from a new observational study. The data from Deliver 2 showed that patients with Type II diabetes who switched to Toujeo from other basal insulins had significantly lower risk of hypoglycemia without compromising blood sugar control.
The Deliver 2 study analyzed electronic medical records for 1,894 patients in 2 matched cohorts, comparing changes to average blood sugar levels, as well as the rate of hypoglycemia and hypoglycemic events related to inpatient or emergency department visits in patients using Toujeo compared to other b...
Source: Mass Device - April 3, 2017 Category: Medical Equipment Authors: Sarah Faulkner Tags: Clinical Trials Diabetes Pharmaceuticals Wall Street Beat Sanofi-Aventis Source Type: news
Once-weekly semaglutide demonstrated consistent blood glucose reductions and weight loss regardless of background oral antidiabetic treatment
Findings from a post hoc analysis of the phase 3a SUSTAIN 2-4 trials demonstrated greater mean reductions in HbA1c and body weight with once-weekly semaglutide treatment compared to sitagliptin, exenatide extended release (ER) and insulin glargine U100 in adults with type 2 diabetes, across multiple background oral antidiabetic (OAD) treatment categories. (Source: World Pharma News)
Source: World Pharma News - April 3, 2017 Category: Pharmaceuticals Tags: Featured Novo Nordisk Business and Industry Source Type: news
Tackling a Decade of Change
There has never been a more exciting time to be in the pharmaceutical industry – if you like change, that is. While change is a constant in business, pharma has experienced unprecedented levels over the past decade, says Alistair Grenfell, President, North Europe, Middle East and Africa, at QuintilesIMS.“At a time when we are seeing a huge amount of innovation in our science and our pipeline – creating great excitement among the healthcare community – we need to acknowledge that our world has changed,” says Grenfell. “If you wind the clock back to 2005 and look at the top 10 selling medic ines, only one was a s...
Source: EyeForPharma - March 23, 2017 Category: Pharmaceuticals Authors: Hugh Gosling Source Type: news
Eli Lilly wins label expansion for Trulicity injection with basal insulin
Eli Lilly (NYSE:LLY) said today that the FDA approved label changes for its once-weekly Trulicity injection. The new label was updated to include use in combination with basal insulin for adults with Type 2 diabetes.
The label update was based on results from a phase IIIb randomized clinical trial, Lilly said, which evaluated Trulicity as an add-on to titrated insulin glargine for 28 weeks. The data showed that the Trulicity-insuline glargine combination significantly lowered A1C compared to a placebo with insulin glargine.
Get the full story at our sister site, Drug Delivery Business News.
The post Eli Lilly wins labe...
Source: Mass Device - February 8, 2017 Category: Medical Equipment Authors: Sarah Faulkner Tags: Diabetes Drug-Device Combinations Food & Drug Administration (FDA) Pharmaceuticals Regulatory/Clearance Eli Lilly & Co. Source Type: news
Sanofi points to lower profit for 2017
French drugmaker says it will continue to reshape group as it offsets Lantus decline (Source: FT.com - Drugs and Healthcare)
Source: FT.com - Drugs and Healthcare - February 8, 2017 Category: Pharmaceuticals Source Type: news
Sanofi ’ s Suliqua combination therapy approved in European Union
Sanofi (NYSE:SNY) said today that the European Commission granted marketing authorization in Europe for its Suliqua combination product for adults with type II diabetes. The therapy is a fixed-ratio combination of basal insulin glargine and lixisenatide, intended to be used with metformin to improve patients’ glycemic control.
Suliqua will be available in 2 pre-filled SoloSTAR pens at different dosage levels to address the insulin needs of individual patients, Sanofi reported. The 10–40 pen will deliver 10-40 dose steps of insulin glargine at 100 Units/mL with 5-20 micrograms of lixisenatide. The 2nd pen will...
Source: Mass Device - January 18, 2017 Category: Medical Equipment Authors: Sarah Faulkner Tags: Diabetes Drug-Device Combinations Pharmaceuticals Regulatory/Clearance Wall Street Beat Sanofi-Aventis Source Type: news
Sanofi confident it can overturn Praluent ruling
French drugmaker faces questions over how to offset declining Lantus revenues (Source: FT.com - Drugs and Healthcare)
Source: FT.com - Drugs and Healthcare - January 12, 2017 Category: Pharmaceuticals Source Type: news
Sanofi sues Nordisk over Tresiba marketing claims in U.S.
Sanofi (NYSE:SNY) said yesterday that it is suing competitor Novo Nordisk (NYSE:NVO) for “misleading” marketing materials that claim Sanofi’s insulin drugs Lantus and Toujeo will be “blocked” by U.S. pharmacy benefit manager CVS Caremark in January and that patients should switch to Nordisk’s Tresiba.
CVS is replacing both Sanofi’s and Nordisk’s drugs with Eli Lilly’s Basaglar on its standard formulary, but Sanofi said that many health plans don’t follow CVS’s standard list and even those that do will probably continue to cover the company’s drugs.
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Source: Mass Device - December 28, 2016 Category: Medical Equipment Authors: Sarah Faulkner Tags: Diabetes Drug-Device Combinations Legal News Pharmaceuticals Wall Street Beat Actelion Johnson & Johnson Novo Nordisk Sanofi-Aventis Source Type: news
Soliqua 100/33 for the Treatment of Type 2 Diabetes
Developed by Sanofi, Soliqua 100/33 (insulin glargine& Lixisenatide injection) is indicated for the treatment of Type 2 diabetes. (Source: Drug Development Technology)
Source: Drug Development Technology - December 19, 2016 Category: Pharmaceuticals Source Type: news
Lilly, Boehringer ’ s Basaglar long-acting insulin now available in the U.S.
Eli Lilly (NYSE:LLY) and Boehringer Ingelheim Pharmaceuticals said today that its insulin glargine injection, Basaglar, is available by prescription in the U.S. Basaglar is a long-acting insulin with the same amino acid sequence as Sanofi‘s (NYSE:SNY) Lantus.
The companies also offer resources for patients beginning insulin treatment, including an app for smartphones and tablets which provides guidance for injection using the Basaglar KwikPen, injection demo kits and educational videos.
Get the full story at our sister site, Drug Delivery Business News.
The post Lilly, Boehringer’s Basaglar long-acting insuli...
Source: Mass Device - December 15, 2016 Category: Medical Equipment Authors: Sarah Faulkner Tags: Diabetes Drug-Device Combinations Pharmaceuticals Wall Street Beat Boehringer Ingelheim Pharmaceuticals Eli Lilly & Co. Sanofi-Aventis Source Type: news
Soliqua Injection (Insulin Glargine and Lixisenatide) - new on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - December 2, 2016 Category: Drugs & Pharmacology Source Type: news
Nordisk touts Tresiba insulin injection data
Novo Nordisk (NYSE:NVO) said today that data from the Devote clinical trial indicated that its injected insulin, Tresiba, reduced the risk of severe hypoglycemia when compared to insulin glargine.
The trial enrolled more than 7,500 type 2 diabetes patients at high risk of adverse cardiovascular events and treated them for 2 years with either Tresiba or insulin glargine U100. The long term analysis sought to confirm interim data that the Denmark-based company used to support its FDA approval for Tresiba in September last year.
Get the full story at our sister site, Drug Delivery Business News.
The post Nordisk touts Tre...
Source: Mass Device - November 30, 2016 Category: Medical Equipment Authors: Sarah Faulkner Tags: Clinical Trials Diabetes Drug-Device Combinations Food & Drug Administration (FDA) Pharmaceuticals Novo Nordisk Source Type: news
