Degludec

Type: Product
Name: Degludec
First reported Aug 19 2014 - Updated Aug 19 2014 - 1 reports

Insulin Market Heats Up as Biosimilars and Newer Forms Emerge

The US Food and Drug Administration (FDA) has issued a tentative approval for Lilly and Boehringer Ingelheim's insulin glargine product, to be called Basaglar , for use in adults with type 2 diabetes and both children and adults with type 1 d ... [Published General Medicine eJournal - Aug 19 2014]
First reported Aug 18 2014 - Updated Aug 18 2014 - 3 reports

Novo Nordisk accepts Danish fine regarding late disclosure of FDA complete response letter for Tresiba, Ryzodeg

Novo Nordisk announced Monday that it agreed to pay a fine of 500 000 Danish kroner ($90 000) imposed by authorities in Denmark for failing to inform investors soon enough that the FDA had declined to approve its diabetes drugs Tresiba (insulin degludec) ... [Published FirstWord Pharma - Aug 18 2014]
First reported Aug 14 2014 - Updated Aug 14 2014 - 1 reports

CHMP positive opinion for Xultophy

Novo Nordisk has announced that the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) has adopted a positive opinion for Xultophy, the first ever once-daily basal insulin (insulin degludec, Tresiba) and GLP-1 ... [Published European Pharmaceutical Manufacturer - Aug 14 2014]
First reported Aug 14 2014 - Updated Aug 14 2014 - 1 reports

Sihuan (00460), Chongqing Biotech sign collaborative agt

AM (Infocast News) Sihuan Pharmaceutical Holdings Group Ltd. (00460) has entered into a collaborative development agreement with Chongqing Peg-Bio BioTechnology Co., Ltd (Chongqing Biotech), pursuant to which Chongqing Biotech agreed to collaborate with ... [Published CCB International - Aug 14 2014]
First reported Aug 11 2014 - Updated Aug 12 2014 - 2 reports

Data demonstrates 'efficacy and tolerability' of IDegLira

A 'significantly greater glucose-lowering effect with IDegLira' has been shown.11 August, 2014 05:33 PMDiabetes Care has published phase IIIa findings that demonstrate a significantly greater glucose-lowering effect with IDegLira (insulin degludec/liraglutide; ... [Published Hospital Pharmacy Europe - Aug 12 2014]
First reported Aug 08 2014 - Updated Aug 08 2014 - 1 reports

Added benefit of Novo Nordisk’s Tresiba not proven, says IQWiG

In an early benefit assessment under the German Act on the Reform of the Market for Medicinal Products (AMNOG), the German Institute for Quality and Efficiency in Health Care (IQWiG) has now examined whether Danish diabetes care giant Novo Nordisk’s (NOV: ... [Published Pharma Letter - Aug 08 2014]
Entities: IQWiG, Insulin, Degludec
First reported Aug 07 2014 - Updated Aug 08 2014 - 2 reports

Novo Nordisk tops Q2 profit estimates, advances potential US launch of Tresiba

Novo Nordisk reported Thursday that second-quarter profit gained 4 percent year-on-year to 7 billion Danish kroner ($1.3 billion), beating the 6.9 billion kroner ($1.2 billion) analysts were expecting. Sales in the three-month period climbed 1 percent ... [Published FirstWord Pharma - Aug 07 2014]
First reported Aug 05 2014 - Updated Aug 05 2014 - 1 reports

Transparency Issues Floor Novo Nordisk's Tresiba At IQWiG

MEPs Pass Clinical Trials Laws But Implementation Will Be Troublesome “The Pink Sheet” DAILY Apr. 3, 2014Novo Nordisk Withholding Tresiba From German HTA Process “The Pink Sheet” DAILY Aug. 20, 2013Novo Nordisk Dismayed By “Complete Response” ... [Published Health News Daily - Aug 05 2014]
First reported Aug 04 2014 - Updated Aug 04 2014 - 1 reports

Novo Nordisk Diabetes Drug Xultophy (IDegLira) Gets Positive CHMP View

Xultophy, a type 2 diabetes candidate, received a positive opinion from the European Medicines Agency's Committee. Xultophy is a once-daily single injection combination of insulin degludec and liraglutide. The CHMP recommended the approval of Xultophy ... [Published Diabetes in Control - Aug 04 2014]
First reported Jul 25 2014 - Updated Jul 25 2014 - 1 reports

EU Panel Endorses Use of 2 Diabetes-Related Products

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued 2 new positive opinions for products related to the treatment of patients with diabetes.The CHMP recommended granting market authorization for ... [Published Diabetes Care - Jul 25 2014]
First reported Jul 25 2014 - Updated Jul 25 2014 - 2 reports

Novo Nordisk receives positive opinion on Xultophy® (IDegLira) from the European regulatory authorities

- Novo Nordisk today announced that the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) adopted a positive opinion, recommending marketing authorisation for Xultophy® CVR no: 24 25 67 90 Company announcement ... [Published Noodls - Jul 25 2014]
First reported Jul 25 2014 - Updated Jul 25 2014 - 4 reports

Novo's blockbuster diabetes combo nears EU approval

A committee of European Medicines Agency advisers is recommending approval for Novo Nordisk's ($NVO) combination of a long-acting insulin and its blockbuster GLP-1 drug Victoza, setting the stage for a near-term approval of what's expected to be the diabetes ... [Published FierceBiotech - Jul 25 2014]

Quotes

Dr. Lane says concentrated insulins are scoring highly on 1 scale, however. "Patients who were questioned after the switch to U500 expressed more content"
...assess the impacts of the complete response letter, in which the agency requested more data from a dedicated cardiovascular outcomes trial. "However, for resource reasons, [our] management has chosen to accept the fine to avoid a lengthy lawsuit" the company said, adding "this will finally settle the case."
...CEO Lars Rebien Sørensen said "this has enabled us to shorten further the timeline towards…a potential US launch of Tresiba" which he noted is "doing well in key markets."
Chief executive Lars Rebien Sorensen commented: "We are satisfied with the financial results achieved in a challenging first half of 2014. Tresiba [insulin degludec] is doing well in key markets and the DEVOTE trial continues to progress ahead of plans. This has enabled us to shorten further the timeline towards the interim analysis and a potential US launch of Tresiba. Furthermore, with the  positive opinion for Xultophy [insulin degludec/liraglutide] from the EU regulatory authorities, we have passed a key milestone in bringing the first insulin and GLP-1 combination product to the market."

More Content

All (41) | News (34) | Reports (0) | Blogs (6) | Audio/Video (0) | Fact Sheets (0) | Press Releases (1)
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Insulin Market Heats Up as Biosimilars and Newe... [Published General Medicine eJournal - Aug 19 2014]
Novo Nordisk accepts Danish fine regarding late... [Published FirstWord Pharma - Aug 18 2014]
Novo accepts Denmark fine in Tresiba disclosure... [Published Pharma Times - Aug 18 2014]
Novo Nordisk to pay Danish fine for late disclo... [Published FirstWord Pharma - Aug 18 2014]
CHMP positive opinion for Xultophy [Published European Pharmaceutical Manufacturer - Aug 14 2014]
Sihuan (00460), Chongqing Biotech sign collabor... [Published CCB International - Aug 14 2014]
Novo Nordisk’s GLP-1/insulin combination, Xulto... [Published diaTribe - Aug 12 2014]
Data demonstrates 'efficacy and tolerability' o... [Published Hospital Pharmacy Europe - Aug 12 2014]
Positive new Ph III data with Novo Nordisk’s Xu... [Published Pharma Letter - Aug 11 2014]
Novo says Tresiba trial is ahead of schedule [Published MedNous - Aug 08 2014]
Added benefit of Novo Nordisk’s Tresiba not pro... [Published Pharma Letter - Aug 08 2014]
Novo Nordisk tops Q2 profit estimates, advances... [Published FirstWord Pharma - Aug 07 2014]
Novo Nordisk beats estimates as net profit grow... [Published Pharma Letter - Aug 07 2014]
Novo Nordisk A/S: Novo Nordisk increased operat... [Published EuroInvestor - Aug 07 2014]
Transparency Issues Floor Novo Nordisk's Tresib... [Published Health News Daily - Aug 05 2014]
Novo Nordisk Diabetes Drug Xultophy (IDegLira) ... [Published Diabetes in Control - Aug 04 2014]
AWMSG decisions [Published Pharmaceutical Journal - Jul 30 2014]
Novo Nordisk Diabetes Drug Xultophy Gets Positi... [Published Zacks.com - Jul 29 2014]
CHMP positive opinion for Xultophy? [Published Hospital Pharmacy Europe - Jul 28 2014]
Blood cancer drugs lead batch of CHMP nods [Published Pharma Times - Jul 27 2014]
Xultophy, Accofil and Busulfan recommended by E... [Published Pharma Letter - Jul 26 2014]
EU Panel Endorses Use of 2 Diabetes-Related Pro... [Published Diabetes Care - Jul 25 2014]
CHMP Recommends MA for Diabetes Drug [Published Drug Discovery and Development - Jul 25 2014]
Novo's blockbuster diabetes combo nears EU appr... [Published FierceBiotech - Jul 25 2014]
Novo Nordisk receives positive opinion on Xulto... [Published Noodls - Jul 25 2014]
Novo Wins EU Recommendation for Diabetes Drug [Published TVNewsCheck - Jul 25 2014]
Novo Nordisk gains CHMP backing for Tresiba, Vi... [Published FirstWord Pharma - Jul 25 2014]
Novo wins EU recommendation for two-in-one diab... [Published DailyMe.Com - Jul 25 2014]
Novo Nordisk A/S: Novo Nordisk receives positiv... [Published GlobeNewswire: Acquisitions News - Jul 25 2014]
Novo wins EU recommendation for two-in-one diab... [Published CNBC - Jul 25 2014]
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Blogs

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Novo Nordisk's Insulin Degludec/Liraglutide is ... [Published PR Newswire: General Business - Jul 07 2014]
BURLINGTON, Mass., July 7, 2014 /PRNewswire/ -- Decision Resources Group finds that Novo Nordisk's fixed-dose combination (FDC) therapy insulin degludec/liraglutide (Xultophy, formerly known as IDegLira) is set to become the clinical gold-standard ...
Human medicines European public assessment repo... [Published Pending EC decisions and European Public Assess ... - Jun 26 2014]
Opinion/decision on a Paediatric Investigation ... [Published Opinion/decision on a Paediatric Investigation ... - Jun 25 2014]
New One-year Data of IDegLira Shows Glucose-low... [Published PR Newswire: Health - Jun 14 2014]
SAN FRANCISCO, June 14, 2014 /PRNewswire/ --New Phase 3a findings show IDegLira, the investigational once-daily single injection combination of insulin degludec and liraglutide, for the treatment of people with type 2 diabetes, maintained its glucose-lowering ...
“Race, Risk and Behaviors: A Type 2 Diabetes Up... [Published theCSRfeed - Apr 29 2014]
SOURCE: Elsevier DESCRIPTION: Philadelphia, April 29, 2014 /3BL Media/ – Clinical Therapeutics features a special report in its April issue focusing primarily on the behavioral issues associated with patients’ self-management of type 2 diabetes. ...
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Press Releases

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Novo Nordisk A/S: Novo Nordisk receives positiv... [Published GlobeNewswire: Acquisitions News - Jul 25 2014]
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