FDA Expands Use of Toujeo to Childhood Type 1 Diabetes FDA Expands Use of Toujeo to Childhood Type 1 Diabetes
First approved for US adults with type 1 and type 2 diabetes in 2015, Toujeo (insulin glargine 300 units/mL injection) may now be used in children as young as 6 years with type 1 diabetes.Medscape Medical News (Source: Medscape Diabetes Headlines)
Source: Medscape Diabetes Headlines - December 3, 2019 Category: Endocrinology Tags: Diabetes & Endocrinology News Alert Source Type: news

FDA Expands Use of Toujeo to Childhood Diabetes FDA Expands Use of Toujeo to Childhood Diabetes
First approved for US adults in 2015, Toujeo (insulin glargine 300 units/mL injection) may now be used in children as young as 6 years with type 1 or type 2 diabetes.Medscape Medical News (Source: Medscape Diabetes Headlines)
Source: Medscape Diabetes Headlines - December 3, 2019 Category: Endocrinology Tags: Diabetes & Endocrinology News Alert Source Type: news

USFDA issues response letter for new drug application for insulin glargine: Biocon
Biocon is confident of addressing these observations through a corrective and preventive action plan in a timely manner, it added. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - August 31, 2019 Category: Pharmaceuticals Source Type: news

insulin glargine (Lantus)
Title: insulin glargine (Lantus)Category: MedicationsCreated: 3/2/2005 12:00:00 AMLast Editorial Review: 7/1/2019 12:00:00 AM (Source: MedicineNet Diabetes General)
Source: MedicineNet Diabetes General - July 1, 2019 Category: Endocrinology Source Type: news

Insulin glargine cost  effective versus NPH insulin in Hong Kong
(Source: PharmacoEconomics and Outcomes News)
Source: PharmacoEconomics and Outcomes News - July 1, 2019 Category: Drugs & Pharmacology Source Type: news

FDA Drug Safety Communication: Update to ongoing safety review of Lantus (insulin glargine) and possible risk of cancer
[1-12-2011] The U.S. Food and Drug Administration (FDA) is updating the public about its ongoing safety review of Lantus (insulin glargine) and a possible increased risk of cancer. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - June 19, 2019 Category: Drugs & Pharmacology Authors: FDA Source Type: news

ADA: Combo Injectable Controls Blood Glucose Longer in T2DM
FRIDAY, June 14, 2019 -- Compared with insulin glargine, initial injectable therapy with a combination of insulin degludec and liraglutide aids achievement of blood glucose goals for a longer period of time in patients with uncontrolled type 2... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - June 14, 2019 Category: Pharmaceuticals Source Type: news

Combination medication helps patients with type 2 diabetes maintain blood sugar goals
(Brigham and Women's Hospital) Through a randomized, multicenter clinical trial, investigators studied blood glucose results for patients assigned to either take insulin (insulin glargine, IGlar U100) or insulin degludec plus liraglutide (IDegLira), a combination of both insulin and an additional medication to help with blood sugar control. The global study team found that participants who received IDegLira were better able to achieve blood glucose goals and remain at that goal longer compared to those assigned to receive IGlar. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - June 9, 2019 Category: International Medicine & Public Health Source Type: news

FDA Expands Indication for Soliqua 100/33 (insulin glargine and lixisenatide injection) to Include Type 2 Diabetes Patients Uncontrolled on Oral Antidiabetic Medicines
BRIDGEWATER, N.J., Feb. 27, 2019 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) has approved the expanded use of Soliqua 100/33 (insulin glargine and lixisenatide injection) 100 Units/mL and 33 mcg/mL. Previously approved for use as an... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - February 27, 2019 Category: Drugs & Pharmacology Source Type: news

Study: Even Older Drugs Getting Steep Price Hikes
The cost of a two-pack EpiPen injector has increased from around $100 in 2007 to between $300 and $600 today. The list price for Lantus brand insulin increased by 49 percent in 2014, even though the product has been on the market for more than a decade. (Source: WebMD Health)
Source: WebMD Health - January 8, 2019 Category: Consumer Health News Source Type: news

Metformin vs. Lantus
Title: Metformin vs. LantusCategory: MedicationsCreated: 12/20/2018 12:00:00 AMLast Editorial Review: 12/20/2018 12:00:00 AM (Source: MedicineNet Medications General)
Source: MedicineNet Medications General - December 20, 2018 Category: Drugs & Pharmacology Source Type: news

Mylan says Sanofi loses Lantus insulin patent claims
U.S. generics drugmaker Mylan said on Thursday that the United States Patent and Trademark Office had rejected Sanofi's infringement claims relating to insulin drug Lantus. (Source: Reuters: Health)
Source: Reuters: Health - December 13, 2018 Category: Consumer Health News Tags: healthNews Source Type: news

Sanofi's Formulation Patents on Multibillion-Dollar Lantus(R) are Invalidated by U.S. Patent and Trademark Office via IPR, Announces Mylan
Mylan achieves key milestone to provide U.S. diabetes patients with more affordable generic version of Sanofi's Lantus® insulin glargine vials HERTFORDSHIRE, England and PITTSBURGH, Dec. 13, 2018 -- (Healthcare Sales & Marketing Network) -- Mylan N... Biopharmaceuticals, Generics, Endocrinology, Litigation Mylan, Sanofi, Lantus, insulin glargine, Lantus SoloSTAR (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - December 13, 2018 Category: Pharmaceuticals Source Type: news

Mylan wins lawsuit over insulin formulation patents
Mylan announced Thursday that the U.S. Patent and Trademark Appeal Board had ruled in its favor, allowing the Canonsburg-based pharmaceutical company to continue making a generic insulin glargine vial. Mylan has spent years investing in a generic insulin glargine, which is used by diabetes patients to control their blood sugar. The insulin glargine, marketed as Lantus, was created by French pharmaceutical company Sanofi and is sold in vials or as a disposable injection pen. Sanofi initiated pa tent… (Source: bizjournals.com Health Care:Pharmaceuticals headlines)
Source: bizjournals.com Health Care:Pharmaceuticals headlines - December 13, 2018 Category: Pharmaceuticals Authors: Luke Torrance Source Type: news

Sanofi loses Lantus patent claims against Mylan
U.S. generics drugmaker Mylan N.V. said on Thursday the U.S. Patent and Trademark Office rejected French pharma company Sanofi's patent infringement claims related to two formulations of its blockbuster insulin drug Lantus. (Source: Reuters: Health)
Source: Reuters: Health - December 13, 2018 Category: Consumer Health News Tags: healthNews Source Type: news

Mylan says patent office cancels Sanofi's Lantus patents
Mylan N.V. said on Thursday the U.S. Patent and Trademark Office invalidated French drug company Sanofi's formulation patents on its blockbuster insulin drug Lantus, ruling in favor of the U.S. drugmaker. (Source: Reuters: Health)
Source: Reuters: Health - December 13, 2018 Category: Consumer Health News Tags: healthNews Source Type: news

IDegLira vs Insulin Glargine U100 Plus Insulin Aspart IDegLira vs Insulin Glargine U100 Plus Insulin Aspart
Is IDegLira a more cost-effective treatment choice for type 2 diabetes than insulin glargine U100 plus insulin aspart?Endocrine Practice (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - November 20, 2018 Category: Consumer Health News Tags: Diabetes & Endocrinology Journal Article Source Type: news

Diabetes and Dollars: Cost-of-Care Quiz
True or False: In 2015, Americans spent more on insulin glargine than any other drug. The answer and 9 more questions in our quiz. (Source: ConsultantLive)
Source: ConsultantLive - July 27, 2018 Category: Internal Medicine Authors: Grace Halsey Tags: Diabetes Source Type: news

Insulin Glargine 300 Safe, Effective in Seniors With T2DM
TUESDAY, June 26, 2018 -- For older adults, insulin glargine 300 units/mL (Gla-300) is safe and as effective as Gla-100, with a similarly low or lower risk of symptomatic hypoglycemia, according to a study published online June 12 in Diabetes... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - June 26, 2018 Category: Pharmaceuticals Source Type: news

Toujeo (Insulin Glargine Injection for Subcutaneous Use) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - April 9, 2018 Category: Drugs & Pharmacology Source Type: news

FDA approves Toujeo(R) Max SoloStar(R)
Max SoloStar holds more insulin than any other long-acting insulin pen New pen can potentially reduce the number of injections for people who need more long-acting insulin and lower copay costs BRIDGEWATER, N.J., March 27, 2018 -- (Healthcare Sales &... Biopharmaceuticals, Drug Delivery, FDA Sanofi, Toujeo, insulin glargine, insulin pen, insulin, diabetes (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - March 27, 2018 Category: Pharmaceuticals Source Type: news

Sanofi ’ s high-capacity insulin pen wins FDA nod
Sanofi (NYSE:SNY) reported today that its Toujeo Max SoloStar high-capacity insulin pen won FDA approval and will be available in the third quarter of this year. The new device holds 900 units of long-acting insulin and delivers 160 units/mL of Toujeo insulin glargine in each injection, the insulin-maker touted. Get the full story at our sister site, Drug Delivery Business News. The post Sanofi’s high-capacity insulin pen wins FDA nod appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - March 27, 2018 Category: Medical Devices Authors: Sarah Faulkner Tags: Diabetes Drug-Device Combinations Food & Drug Administration (FDA) Pharmaceuticals Regulatory/Compliance Wall Street Beat Sanofi-Aventis Source Type: news

FDA Approves Toujeo (insulin glargine) Max SoloStar
BRIDGEWATER, N.J., March 27, 2018 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) approved Sanofi's Toujeo (insulin glargine 300 Units/mL) Max SoloStar, the highest capacity long-acting insulin pen that will be available on the... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - March 27, 2018 Category: Drugs & Pharmacology Source Type: news

FDA approves label update to Novo Nordisk ’s Tresiba diabetes drug
The FDA approved Novo Nordisk‘s (NYSE:NVO) request to include heart health data on the label of its Tresiba insulin degludec product. The Danish insulin-maker evaluated its Type II diabetes drug in a 7,637-patient trial, assessing the therapy for cardiovascular safety compared to insulin glargine. Get the full story at our sister site, Drug Delivery Business News. The post FDA approves label update to Novo Nordisk’s Tresiba diabetes drug appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - March 26, 2018 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

FDA approves inclusion of data from safety outcomes trial in the Tresiba(R) label
The data showed that Tresiba® (insulin degludec injection) U-100 had no increased risk of MACE compared to insulin glargine U-100 in patients with type 2 diabetes and ASCVD1 Tresiba® U-100 becomes the first and only long-acting insulin to have d... Biopharmaceuticals, Endocrinology, Cardiology, FDA Novo Nordisk, Tresiba, insulin degludec, insulin (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - March 26, 2018 Category: Pharmaceuticals Source Type: news

Sanofi touts real-world data for Toujeo insulin glargine injection
Sanofi (NYSE:SNY) touted data today from its 10,000-patient Lightning study, which evaluated electronic medical records of adults with Type II diabetes to study its long-acting insulin glargine injection, Toujeo. The company found that Toujeo significantly lowered patients’ risk of experiencing severe low blood sugar compared to other long-acting insulin, like its own Lantus product. Get the full story at our sister site, Drug Delivery Business News. The post Sanofi touts real-world data for Toujeo insulin glargine injection appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - February 14, 2018 Category: Medical Devices Authors: Sarah Faulkner Tags: Diabetes Drug-Device Combinations Pharmaceuticals Wall Street Beat Sanofi-Aventis Source Type: news

FDA Drug Safety Communication: Update to ongoing safety review of Lantus (insulin glargine) and possible risk of cancer
[1-12-2011] The U.S. Food and Drug Administration (FDA) is updating the public about its ongoing safety review of Lantus (insulin glargine) and a possible increased risk of cancer. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 7, 2018 Category: Drugs & Pharmacology Source Type: news

European committee backs Mylan ’ s insulin glargine biosimilar
Mylan (NSDQ:MYL) and Biocon announced today that a European Medicines Agency committee has recommended approval for its biosimilar insulin glargine, Semglee. The committee’s positive opinion brings the product one step closer to approval. The European Commission is slated to make a final decision in April. Get the full story at our sister site, Drug Delivery Business News. The post European committee backs Mylan’s insulin glargine biosimilar appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - January 29, 2018 Category: Medical Devices Authors: Sarah Faulkner Tags: Diabetes Pharmaceuticals Regulatory/Compliance Wall Street Beat biocon Mylan Source Type: news

Sanofi, Facing Threat from Generics, Moves to Buy Hemophilia Drug Maker
The $11.6 billion deal for Bioverativ would bolster the French pharmaceutical giant ’ s portfolio as it faces falling sales for its diabetes drug, Lantus. (Source: NYT Health)
Source: NYT Health - January 22, 2018 Category: Consumer Health News Authors: CHAD BRAY Tags: Mergers, Acquisitions and Divestitures Drugs (Pharmaceuticals) Hemophilia Sanofi SA Brandicourt, Olivier Source Type: news

Mylan Announces the U.S. Patent and Trademark Appeal Board Institutes Inter Partes Review Proceedings on All Claims Against Sanofi's Lantus(R) Patents
HERTFORDSHIRE, England and PITTSBURGH, Dec. 14, 2017 -- (Healthcare Sales & Marketing Network) -- Mylan N.V. (NASDAQ, TASE: MYL) today announced that the U.S. Patent and Trademark Appeal Board (PTAB) has instituted inter partes review (IPR) proceedings on... Biopharmaceuticals, Generics, Litigation Mylan, Sanofi, Lantus, insulin glargine (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - December 14, 2017 Category: Pharmaceuticals Source Type: news

Appeal board to review Sanofi ’ s Lantus insulin injection patents
The U.S. Patent and Trademark Appeal Board has instituted inter partes review on all claims against two patents owned by Sanofi (NYSE:SNY) for the company’s Lantus insulin glargine injection. Sanofi filed a patent infringement suit against Mylan (NSDQ:MYL) in October after the EpiPen-maker submitted an NDA for a pre-filled insulin glargine pen, challenging the patents listed for Sanofi’s Lantus products. Get the full story at our sister site, Drug Delivery Business News. The post Appeal board to review Sanofi’s Lantus insulin injection patents appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - December 14, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Diabetes Drug-Device Combinations Legal News Pharmaceuticals Wall Street Beat Merck Mylan Sanofi-Aventis Source Type: news

Sanofi touts head-to-head comparison of long-acting insulin products
Sanofi‘s (NYSE:SNY) long-acting insulin glargine, Toujeo, met the primary objective of a head-to-head trial comparing it to Novo Nordisk‘s (NYSE:NVO) insulin degludec, Tresiba, the company reported today. The insulin-maker said it plans to report full results from the Bright trial sometime next year. The study’s primary objective was to determine if Toujeo had a similar effect on blood sugar levels compared to insulin degludec. Get the full story at our sister site, Drug Delivery Business News. The post Sanofi touts head-to-head comparison of long-acting insulin products appeared first on MassDevice....
Source: Mass Device - December 4, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Clinical Trials Diabetes Drug-Device Combinations Pharmaceuticals Wall Street Beat Novo Nordisk Sanofi-Aventis Source Type: news

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 no...
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 pate...
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 a...
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 21, 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 trac...
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 - 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

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