News

Novo’s degludec backed by FDA
Enlarge image

RegulatoryDenmark

Novo’s degludec backed by FDA

12.11.2012 - An FDA panel says that Danish Novo Nordisk’s new recombinant insulins pose certain risks but still approves them. The benefit is evident, it states.

A federal advisory panel backed the long-acting insulin degludec by Novo Nordisk A/S. However, it said the company should conduct a post-approval study to address concerns about a possible increased risk of cardiovascular events such as heart attacks and strokes. The decision was not unanimous. Four of the 12 committee members voted against the approval. The proponents felt that the benefits outweigh the risks. The products were Tresiba insulin Degludec, a long-acting insulin analogue, and Ryzodeg, a combination of 70% insulin Degludec and 30% Novo Nordisk's NovoLog (insulin aspart). When balanced with comparators, both drugs are very efficient at reducing hypoglycemia.

The Danish company has already prepared a trial to meet FDA criteria. It has designed as a five-year cardiovascular outcomes trial that would enrol 7,500 type II diabetes patients. The FDA's endocrinologics and metabolic drugs advisory panel is composed of non-FDA medical experts. In Europe, insulin degludec recently received market approval. Recombinant insulins are used to treat diabetes, a disease that is characterised by the body's inability to either make or properly use insulin. Some manufactured insulins – such as Lilly’s Humulin or Novo Nordisk’s Novalin – have already lost patent protection. Others, like Humalog (Eli Lilly), Levemir and Novalog (both Novo Nordisk), and three of Sanofi’s four patents on Lantus , will follow in the next two years. With the advent of recombinant insulin biosimilars, Novo Nordisk is wise to develop a successful successor in the market.

© eurobiotechnews.eu/ml

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.

Stock marketNetherlandsUKBelgium

10.07.2014 Not one but two biopharma companies are seeking entry into the stock market: After Abzena raised €25m in an IPO earlier this week, Argen-x has followed suit and sold shares worth €40m.

M and AUKIreland

08.07.2014 Abbvie is determined to bring home British rare disease specialist Shire in a merger worth £30.1bn (€37.9bn). So far, Shire has rejected all offers from the US company.

M and ASwitzerland

04.07.2014 Genentech, a member of Swiss Roche Group, is set to acquire US-biotech Seragon Pharmaceuticals Inc. With the move, Genentech will obtain the rights to investigational breast cancer treatments.

MandAFranceGermany

03.07.2014 Nicox S.A. is stretching beyond the European market: The French eye health specialist is set to acquire Aciex Therapeutics Inc., a US-based pharma company with several ophthalmic therapeutics nearing market maturity.

FinanceBelgium

01.07.2014 Belgian antibody specialist Ablynx has raised €41.7m through a private placement of new shares and plans on boosting their range of nanobodies in development.

Events

All Events

Current issue

All issues

Product of the week

Products

Stock list

All quotes

TOP

  • MAGFORCE (D)5.90 EUR9.26%
  • ABCAM (UK)387.00 GBP7.72%
  • NANOBIOTIX (F)17.40 EUR7.27%

FLOP

  • ANTISOMA (UK)1.32 GBP-14.84%
  • XENETIC BIOSCIENCES (UK)6.00 GBP-14.29%
  • NOVACYT (F)4.40 EUR-8.33%

TOP

  • WILEX (D)3.12 EUR310.5%
  • SANTHERA (CH)69.30 CHF132.6%
  • ADDEX (CH)4.07 CHF89.3%

FLOP

  • MERCK KGAA (D)63.71 EUR-50.0%
  • THROMBOGENICS (B)8.87 EUR-38.3%
  • HYBRIGENICS (F)1.72 EUR-34.1%

TOP

  • SANTHERA (CH)69.30 CHF3365.0%
  • GW PHARMACEUTICALS (UK)438.00 GBP812.5%
  • PAION (D)2.80 EUR311.8%

FLOP

  • CYTOS (CH)0.25 CHF-92.7%
  • EVOCUTIS (UK)0.21 GBP-92.1%
  • THROMBOGENICS (B)8.87 EUR-71.1%

No liability assumed, Date: 22.07.2014