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.
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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, where Merck has fought p...
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 deal invo...
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
