Degludec

Type: Product
Name: Degludec
First reported Jul 27 2014 - Updated Jul 27 2014 - 1 reports

Blood cancer drugs lead batch of CHMP nods

Five new medicines are a giant leap closer to entering the European market after having been recommended for approval by the European Medicines Agency's Committee for Medicinal Products for Human Use.First up, the CHMP has adopted a positive opinions ... [Published Pharma Times - Jul 27 2014]
First reported Jul 25 2014 - Updated Jul 25 2014 - 1 reports

BRIEF-EU medicines agency backs new drugs from Novo Nordisk, J&J, Gilead

The European Medicines Agency:* EU medicines agency says recommends Novo Nordisk diabetestreatment degludec/liraglutide * EU medicines agency says recommends Johnson & Johnson Pharmacyclicsleukaemia drug ibrutinib * EU medicines agency says recommends ... [Published Reuters - Jul 25 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]
First reported Jul 24 2014 - Updated Jul 24 2014 - 1 reports

What Do We Want Out of Our Diabetes Treatments?

We want our diabetes treatments to be effective, but we also want them to be safe, and it is up to the FDA to decide if the benefits of a given medication outweigh the risks. Consider insulin: if misused, it can kill you, but its benefits – it keeps all ... [Published diaTribe - Jul 24 2014]
First reported Jul 08 2014 - Updated Jul 08 2014 - 1 reports

Survey: Insulin Degludec/Liraglutide Set to Become ‘Gold Standard’ Among Fixed-Dose Combo Therapies for Type-2 Diabetes

News Categories Need remains for agents that can elicit greater weight lossDecision Resources Group, a health care research firm located in Burlington, Mass., reports that insulin degludec/liraglutide (Xultophy, Novo Nordisk; formerly known as IDegLira), ... [Published P&T Community - Jul 08 2014]
First reported Jul 07 2014 - Updated Jul 07 2014 - 5 reports

Novo Nordisk's Insulin Degludec/Liraglutide Is Set To Become The Clinical Gold-Standard Among Fixed-Dose Combination Therapies For Type 2 Diabetes

BURLINGTON, Mass.Other key findings from the DecisionBase report entitled : Prescribing decisions: Surveyed U.S. and European endocrinologists agree that a therapy's ability to reduce glycated hemoglobin A1c (HbA1c) is the attribute that most influences ... [Published TheStreet.com - Jul 07 2014]
First reported Jun 29 2014 - Updated Jun 29 2014 - 1 reports

ADA: Degludec and Liraglutide Fixed Combo Shows Continued Efficacy

Stephen C. L. Gough, MD, of the Oxford Centre for Diabetes, Endocrinology & Metabolism presented the extension of a 26-week trial, DUAL 1, which produced sustained benefits at 1 year. DUAL 1 looked at 1,311 patients with type 2 diabetes, who are uncontrolled ... [Published Diabetes in Control - Jun 29 2014]
First reported Jun 26 2014 - Updated Jun 26 2014 - 1 reports

Human medicines European public assessment report (EPAR): Tresiba, insulin degludec, Revision: 2, Authorised

Entities: Degludec, Tresiba, Insulin
First reported Jun 22 2014 - Updated Jun 22 2014 - 1 reports

ADA: New Combination Diabetes Drug Effective After 1 Year Study

The combination therapy also helped more patients achieve recommended blood sugar levels and appeared to reduce side effects of each of the drugs when taken alone.After 52 weeks of treatment, patients taking the combination drug IDegLira had an average ... [Published Diabetes in Control - Jun 22 2014]

Quotes

"Xultophy is indicated for the treatment of adults with type 2 diabetes mellitus to improve glycaemic control in combination with oral glucose-lowering medicinal products when these alone or combined with basal insulin do not provide adequate glycaemic control" according to an EMA news release
"We are excited about the positive opinion for Xultophy from the CHMP. We believe that Xultophy represents a new treatment paradigm with the potential to transform how type 2 diabetes is treated. We look forward to making the product available to people with type 2 diabetes in Europe" said Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk
"We believe that Xultophy represents a new treatment paradigm with the potential to transform how type 2 diabetes is treated" remarked Novo Nordisk chief science officer Mads Krogsgaard Thomsen...
...drawback highlighted by interviewed thought leaders is the less-flexible titration offered by these combinations compared with individual agents. "While both surveyed physicians and payers highlight greater reductions in body weight as a key unmet need, the development of novel agents with improved efficacy in reducing HbA1c remains the greatest opportunity for pharmaceutical companies working in type 2 diabetes."

More Content

All (33) | News (26) | Reports (0) | Blogs (6) | Audio/Video (0) | Fact Sheets (0) | Press Releases (1)
sort by: Date | Relevance
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]
BRIEF-EU medicines agency backs new drugs from ... [Published Reuters - Jul 25 2014]
What Do We Want Out of Our Diabetes Treatments? [Published diaTribe - Jul 24 2014]
Survey: Insulin Degludec/Liraglutide Set to Bec... [Published P&T Community - Jul 08 2014]
Afrezza Approval Comes With Post-Marketing Tria... [Published Health News Daily - Jul 07 2014]
Novo Nordisk's Insulin Degludec/Liraglutide Is ... [Published TheStreet.com - Jul 07 2014]
Novo Nordisk's Insulin Degludec/Liraglutide is ... [Published BioSpace - Jul 07 2014]
Novo Nordisk's Insulin Degludec/Liraglutide is ... [Published TickerTech.com - Jul 07 2014]
Novo Nordisk's Insulin Degludec/Liraglutide is ... [Published BusinessWeek - Jul 07 2014]
Novo Nordisk's Insulin Degludec/Liraglutide is ... [Published PR Newswire: General Business - Jul 07 2014]
ADA: Degludec and Liraglutide Fixed Combo Shows... [Published Diabetes in Control - Jun 29 2014]
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]
Sanofi: Toujeo Is Not The Ace In Its Deck [Published Seeking Alpha - Jun 23 2014]
ADA: New Combination Diabetes Drug Effective Af... [Published Diabetes in Control - Jun 22 2014]
Who Will Win This $45 Billion Market? [Published Motley Fool - Jun 20 2014]
Novo says switching to Tresiba could reduce NHS... [Published PMLive - Jun 19 2014]
New One-year Data of IDegLira Shows Glucose-low... [Published PR Newswire: Health - Jun 14 2014]
“Race, Risk and Behaviors: A Type 2 Diabetes Up... [Published theCSRfeed - Apr 29 2014]
Technical Committee denies permission to 19 cli... [Published PharmaBiz - Mar 31 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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