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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 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 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

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 oth...
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 medi...
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...
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 lixisen...
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 ...
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-actin...
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 N...
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

Novo's New Insulin Reduces Risk of Low Blood Sugar, Study Shows
Novo Nordisk said its new insulin Tresiba carries about the same risk of serious heart problems as Sanofi ’s Lantus but offers significantly lower risk of dangerously low blood sugar in people with Type-2 diabetes. (Source: WSJ.com: Health)
Source: WSJ.com: Health - November 30, 2016 Category: Pharmaceuticals Tags: FREE Source Type: news

Novo Nordisk, Sanofi win FDA nods for diabetes drugs
Both Novo Nordisk (NYSE:NVO) and Sanofi (NYSE:SNY) said yesterday that they won FDA approval for pre-filled pens with drug combinations indicated for adults with Type II diabetes. Paris-based Sanofi’s Soliqua 100/33 is an injectable medicine composed of 2 diabetes drugs – insulin glargine and lixisenatide. The drug is approved for adults with Type II diabetes not controlled with less than 60 units daily of long-acting basal insulin or lixisenatide. The pre-filled pen will be available in U.S. retail pharmacies in January, according to Sanofi. Get the full story at our sister site, ...
Source: Mass Device - November 22, 2016 Category: Medical Equipment Authors: Sarah Faulkner Tags: Diabetes Drug-Device Combinations Food & Drug Administration (FDA) Regulatory/Clearance Novo Nordisk Sanofi-Aventis Source Type: news

IDegLira, LixiLan Go Head-to-head as FDA OKs Both for Diabetes IDegLira, LixiLan Go Head-to-head as FDA OKs Both for Diabetes
The first approval for GLP-1 agonist lixisenatide/insulin glargine combo from Sanofi for type 2 diabetes in US will be marketed as Soliqua. Novo Nordisk product Xultophy combines liraglutide and insulin degludec.FDA Approvals (Source: Medscape Diabetes Headlines)
Source: Medscape Diabetes Headlines - November 22, 2016 Category: Endocrinology Tags: Diabetes & Endocrinology News Alert Source Type: news

Sanofi Receives FDA Approval of Soliqua 100/33 (insulin glargine and lixisenatide) for the Treatment of Adults with Type 2 Diabetes
PARIS, Nov. 21, 2016 /PRNewswire-USNewswire/ -- Sanofi announced today that the U.S. Food and Drug Administration (FDA) approved once-daily Soliqua 100/33 (insulin glargine& lixisenatide injection) 100 Units/mL& 33 mcg/mL for the treatment... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - November 21, 2016 Category: Drugs & Pharmacology Source Type: news

EMA Okays LixiLan Plus Biosimilars for Osteoporosis and Diabetes EMA Okays LixiLan Plus Biosimilars for Osteoporosis and Diabetes
The EMA has given a green light to new diabetes medicines, including LixiLan and a new biosimilar version of insulin glargine, as well as two biosimilar versions of teriparatide for osteoporosis.International Approvals (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - November 11, 2016 Category: Consumer Health News Tags: Diabetes & Endocrinology News Alert Source Type: news

EMA accepts review of Mylan's MAA for insulin glargine to treat diabetes
European Medicines Agency (EMA) has accepted review of Mylan's Marketing Authorisation Application (MAA) for insulin glargine, a long-acting insulin analog used to treat adults with type 2 diabetes and adults and pediatric patients (children aged six … (Source: Pharmaceutical Technology)
Source: Pharmaceutical Technology - November 7, 2016 Category: Pharmaceuticals Source Type: news

European Medicines Agency accepts marketing application of Biocon, Mylan product
Mylan and Biocon, which have co-developed insulin glargine, look forward to offering another insulin treatment option for diabetic patients. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - November 3, 2016 Category: Pharmaceuticals Source Type: news

Sanofi sues Merck over injected insulin
  Sanofi Aventis (NYSE:SNY) said today that it filed a patent infringement lawsuit against Merck Sharp & Dohme Corp. (NYSE:MRK) over 10 U.S. patents related to its injected insulin device. The Paris-based company said it is seeking an injunction and damages from Merck for filing a new drug application with the FDA that challenged 10 of Sanofi’s patents covering its Lantus and Lantus SoloStar products. Sanofi’s insulin glargine injection device is a 3 milliliter cartridge, with 100 units of drug per milliliter. Sanofi said it filed the lawsuit in the U.S. District Court for Delaware, wher...
Source: Mass Device - September 19, 2016 Category: Medical Equipment Authors: Sarah Faulkner Tags: Diabetes Drug-Device Combinations Legal News Merck Sanofi-Aventis Source Type: news

Sanofi Files Suit Against Merck
Sanofi said it filed a lawsuit against Merck& Co. for alleged patent infringements to prevent the U.S. drugmaker from launching a rival version of the French pharmaceutical giant ’s best-selling diabetes treatment Lantus. (Source: WSJ.com: Health)
Source: WSJ.com: Health - September 19, 2016 Category: Pharmaceuticals Tags: PAID Source Type: news

Big Pharma firms in patent dispute
French pharmaceutical manufacturer Sanofi filed a patent infringement suit against Merck in the United States District Court for the District of Delaware. Sanofi alleges Merck (NYSE: MRK) infringed of 10 patents covering similar products and methods of delivery. The lawsuit was triggered by a notification received from Merck in early August, in which Merck stated that it had filed a new drug application with the Food Drug Administration seeking app roval of an insulin glargine drug product for patients… (Source: bizjournals.com Health Care:Pharmaceuticals headlines)
Source: bizjournals.com Health Care:Pharmaceuticals headlines - September 19, 2016 Category: Pharmaceuticals Authors: John George Source Type: news

Sanofi's GLP-1/Insulin Combo LixiLan Faces 3-Month Delay in US Sanofi's GLP-1/Insulin Combo LixiLan Faces 3-Month Delay in US
US approval of the GLP-1 receptor agonist lixisenatide and insulin glargine combination LixiLan is delayed over concerns about the delivery device; a decision is now due by November.Medscape Medical News (Source: Medscape Diabetes Headlines)
Source: Medscape Diabetes Headlines - August 25, 2016 Category: Endocrinology Tags: Diabetes & Endocrinology News Source Type: news

FDA request delays timeline for Sanofi ’ s iGlarLixi drug-device combo for diabetes
By Sarah Faulkner The FDA’s request for more data on the iGlarLixi drug-device combination for treating Type II diabetes pushed the timeline for a decision back 3 months, Sanofi (NYSE:SNY) and Zealand Pharma (CPH:ZEAL)said last week. Sanofi said August 19 that it submitted a new data package for iGlarLixi, an injection pen designed to deliver a once-daily dose of Sanofi’s Lantus insulin glargine and the lixisenatide drug it licensed from Zealand Pharma. Sanofi licensed the development and commercialization rights to lixisenatide in 2003, and expanded the deal to include drug-device combinations. The d...
Source: Mass Device - August 24, 2016 Category: Medical Equipment Authors: MassDevice Tags: Diabetes Drug-Device Combinations Food & Drug Administration (FDA) Sanofi-Aventis Zealand Pharma Source Type: news

Zealand Announces New Timelines for a U.S. FDA Decision on iGlarLixi, the Fixed-Ratio Combination of Lixisenatide (Adlyxin) and Lantus, for the Treatment of Type 2 Diabetes
Copenhagen, 20 August 2016 - Zealand Pharma (Zealand) announced today that Sanofi has submitted updated information on the pen delivery device for iGlarLixi to the U.S. Food and Drug Administration (FDA) as part of the New Drug Application (NDA) for... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - August 20, 2016 Category: Drugs & Pharmacology Source Type: news

EndoBreak: Adlyxin Approved; Lantus Nixed by CVS
(MedPage Today) -- News and commentary from the endocrinology world (Source: MedPage Today Endocrinology)
Source: MedPage Today Endocrinology - August 5, 2016 Category: Endocrinology Source Type: news

Merck Announces U.S. FDA Filing Acceptance of New Drug Application (NDA) for MK-1293, an Investigational Follow-On Biologic Insulin Glargine
Dateline City: KENILWORTH, N.J. Marketing Authorization Application to the European Medicines Agency Currently Under ReviewKENILWORTH, 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 accepted for review the New Drug Application (NDA) for MK-1293, an investigational follow-on biologic1 insulin glargine candidate for the treatment of people with type 1 and type 2 diabetes, which is being developed by Merck with partial funding from Samsung Bioepis.Language: EnglishContact: MerckMe...
Source: Merck.com - Research and Development News - August 5, 2016 Category: Pharmaceuticals Tags: Research and Development News Corporate News Latest News #Merck #MRK $MRK Glargine MSD Source Type: news

Merck Announces U.S. FDA Filing Acceptance of New Drug Application (NDA) for MK-1293, an Investigational Follow-On Biologic Insulin Glargine
KENILWORTH, N.J.--(BUSINESS WIRE), August 5, 2016 --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 accepted for review the New Drug Application (NDA) for... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - August 5, 2016 Category: Drugs & Pharmacology Source Type: news

CVS Drops Sanofi's Diabetes Drugs for Biosimilars CVS Drops Sanofi's Diabetes Drugs for Biosimilars
U.S. pharmacy benefit manager CVS will drop Sanofi's main insulin drug Lantus from the list of medicines it reimburses on behalf of health insurers, dealing a blow to the French drugmaker's key diabetes business.Reuters Health Information (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - August 4, 2016 Category: Consumer Health News Tags: Diabetes & Endocrinology News Source Type: news

Lantus (Insulin Glargine [rDNA origin] Injection) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - August 1, 2016 Category: Drugs & Pharmacology Source Type: news

Merck Results Underscore Need To Go Big Or Go Home In Diabetes Market
Looking at the earnings posted by Merck & amp; Co. (MRK), I could not help but compare and contrast them with what Sanofi (SNY) said this morning. Like Sanofi had with Lantus, Merck has a mega-blockbuster with Januvia. Just as Lantus was getting long in the tooth and facing patent expiration so too is Januvia. The main difference is how each company planned for life beyond their respective mega-blockbusters. (Source: Forbes.com Healthcare News)
Source: Forbes.com Healthcare News - July 29, 2016 Category: Pharmaceuticals Authors: David Kliff Source Type: news

EASD: Additional Evidence Showed ABASAGLAR (insulin glargine) Provided Safety and Efficacy Similar to Lantus
(Source: Boehringer Ingelheim Corporate News)
Source: Boehringer Ingelheim Corporate News - July 25, 2016 Category: Research Source Type: news

Eli Lilly and Company and Boehringer Ingelheim announce regulatory submission for new insulin glargine biosimilar product
(Source: Boehringer Ingelheim Corporate News)
Source: Boehringer Ingelheim Corporate News - July 25, 2016 Category: Research Source Type: news

Eli Lilly and Company and Boehringer Ingelheim announce new drug application filing in the U.S. for new insulin glargine product
(Source: Boehringer Ingelheim Corporate News)
Source: Boehringer Ingelheim Corporate News - July 25, 2016 Category: Research Source Type: news

Studies Show Investigational New Insulin Glargine Product from Lilly and Boehringer Ingelheim Similar in Safety and Efficacy to Lantus
(Source: Boehringer Ingelheim Corporate News)
Source: Boehringer Ingelheim Corporate News - July 25, 2016 Category: Research Source Type: news

CHMP Recommends Lilly and Boehringer Ingelheim ’s New Insulin Glargine Product for Approval in the European Union
CHMP Recommends Lilly and Boehringer Ingelheim ’s New Insulin Glargine Product for Approval in the European Union (Source: Boehringer Ingelheim Corporate News)
Source: Boehringer Ingelheim Corporate News - July 25, 2016 Category: Research Source Type: news