News

EU approves Sanofi’s Lyxumia
Enlarge image

RegulatoryEUFranceDenmark

EU approves Sanofi’s Lyxumia

05.02.2013 - The European Commission has granted EU market authorisation to Sanofi’s GLP-1 receptor agonist licisenatide as a diabetes therapy.

The first in class once-daily prandial GLP-1 (glucagon-like peptide-1) receptor agonist, is indicated for the treatment of adults with type 2 diabetes mellitus to achieve glycaemic control as a second line therapy. The decision of the Commission to approve the drug for patients that do not respond to a combination of oral glucose-lowering medicinal products plus basal insulin as well as diet and exercise is based on results from the GetGoal clinical programme

In 11 studies on 5,000 patients, the Paris-based drug maker demonstrated significant HbA1c reductions, a pronounced post-prandial glucose lowering effect and a beneficial effect on body weight in adult patients with type 2 diabetes. GetGoal results also showed that Lyxumia (licisenatide) had a favourable safety and tolerability profile in most patients, with mild and transient nausea and vomiting, the most common adverse events observed in the GLP-1 receptor agonist class, and a limited risk of hypoglycaemia, according to Sanofi.

The therapy, which was licensed from Danish Zealand Pharma A/S in a €170m deal, is indicated when first-line therapy proves no longer effective over time. It strengthens Sanofi’s leading position in the €12bn diabetes market. GLP-1 is a naturally-occurring peptide hormone that is released within minutes after eating a meal. It is known to suppress glucagon secretion from pancreatic alpha cells and stimulate glucose-dependent insulin secretion by pancreatic beta cells

© eurobiotechnews.eu/tg 

BusinessSpainUKSweden

31.07.2014 Astrazeneca is buying the rights to Almirall’s respiratory drugs in a deal worth up to €1.56bn.

BusinessFranceGermanySwitzerlandUK

30.07.2014 Rumours have it that French Danone wants to sell its medical nutrition business to US drugmaker Hospira for US$5bn in yet another tax inversion deal.

RegulationUKEU

29.07.2014 The first vaccine for malaria may be within reach: The European Medicines Agency has accepted Glaxosmithkline’s malaria vaccine candidate RTS,S for regulatory review.

FundingEU

25.07.2014 The European Commission aims to support innovation in Europe and announced a "Fast Track to Innovation" pilot as well as five innovation prices under Horizon 2020.

ResearchUKEU

23.07.2014 In the largest genomic study published on any psychiatric disorder so far, researchers have indentified 83 new locations in the human genome associated with the risk of developing schizophrenia.

BusinessUKIreland

21.07.2014 Abbvie’s tenacious pursuit of British rival Shire is finally paying off: The two companies have unveiled their transatlantic merger worth £32bn (€40bn).

ResearchEUSwitzerland

17.07.2014 A trans-border, cross-disciplinary project that aims to model the human brain in a computer has drawn heavy criticism from scientists pledging to boycott the project.

MergerUK

16.07.2014 After rejecting three merger propositions from US competitor Abbvie, Shire has now given up resistance to the deal and is recommending a new and improved offer worth £31.3bn.

AcquisitionUKDenmarkSpainGermanyFrance

15.07.2014 British specialty pharma company Prostrakan is handing over £230m for Archimedes Pharma Limited, a company that brings its lead product Pecfent and its proprietary drug delivery technology platform into the deal.

FundingEU

11.07.2014 Among the seven newly launched Joint Technology Initiatives (JTI) of Horizon2020 are two with deep roots in biotech: IMI is going into its second round while the newly established Bio-based Industries partnership invests in bioeconomy.

Events

All Events

Current issue

All issues

Product of the week

Products

Stock list

All quotes

TOP

  • PHARMING (NL)0.48 EUR11.63%
  • MDX HEALTH (B)3.80 EUR10.79%
  • NEUROVIVE PHARMACEUTICAL AB (S)70.00 SEK8.53%

FLOP

  • ANTISOMA (UK)1.32 GBP-14.84%
  • XENETIC BIOSCIENCES (UK)6.00 GBP-14.29%
  • NOVACYT (F)4.46 EUR-10.26%

TOP

  • WILEX (D)2.82 EUR231.8%
  • ADDEX (CH)3.80 CHF58.3%
  • NEUROVIVE PHARMACEUTICAL AB (S)70.00 SEK44.9%

FLOP

  • HYBRIGENICS (F)1.72 EUR-29.5%
  • PROSENSA (NL)9.67 USD-23.8%
  • VITA 34 (D)4.18 EUR-20.4%

TOP

  • SANTHERA (CH)59.90 CHF2836.3%
  • GW PHARMACEUTICALS (UK)431.00 GBP676.6%
  • PAION (D)2.42 EUR255.9%

FLOP

  • EVOCUTIS (UK)0.21 GBP-92.6%
  • CYTOS (CH)0.27 CHF-92.0%
  • THROMBOGENICS (B)9.16 EUR-70.4%

No liability assumed, Date: 30.07.2014