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

http://www.european-biotechnology-news.com/news/news/2012-04/novos-degludec-backed-by-fda.html

M&AIreland

31.03.2015 In its aim to expand its drug portfolio in orphan disease products, Horizon Pharma has acquired US company Hyperion Therapeutics for US$1.1bn in cash. The takeover entitles the UK biopharma to all of Hyperion’s common stock.

BusinessGermany

31.03.2015 Merck Serono has forged a US$941m (€876m) deal with US Intrexon for the development and commercialisation of CAR-T therapies. The new CAR-T projects are set to strengthen their R&D technology portfolio in immuno-oncology.

Stock MarketsFranceEU

27.03.2015 Europe is once more proving that it can be a good bet for biotech companies going public. A newly established EU-wide lobbying initiative could help the IPO boom on its way.

FinancingPoland

24.03.2015 Poland has announced the closing of a new venture capital fund at US$42m (€32m). The fund, which is the first of its kind in Poland, is dedicated to the Life Sciences with a strong connection to Central and Eastern Europe.

BioeconomyFranceSwedenGermanyNetherlandsFinland

23.03.2015 A BASF-led consortium aims to decrease bio-based production costs using industrial biotechnology. The Horizon2020 funded consortium is the sixth project of the SPIRE Public Private Partnership and has a budget of €14m.

Stock MarketsFranceSwedenUKNorwayIreland

20.03.2015 There are no signs of inertia creeping into the European biotech industry this spring. A total of eight IPOs are set to go public by the end of the year’s first quarter.

FinancingUKEU

17.03.2015 Pharma giants GlaxoSmithKline (GSK) and Johnson & Johnson (J&J) will be key collaborators in a new global fund for dementia research to address the rising threat posed by dementia and Alzheimer’s disease.

FinancingFranceDenmarkSwedenGermany

19.03.2015 French venture capital firm Seventure Partners has raised a further €25m for its microbiome-focused Health for Life Capital Fund. It now stands at €100m.

EventsFranceEUSwitzerlandUKGermany

12.03.2015 With around 1,400 companies and 2,400 participants, the springtime counterpart of BIO-Europe enjoyed a successful premiere in France this year. The overall mood of the European biotech industry was positive, and the French hosts in particular reported new initiatives.

M&ABelgium

11.03.2015 Belgian cell-based therapeutics developer and CMO MaSTherCell SA has been acquired by US biotech Orgenesis Inc. for €23m.

Events

All Events

Current issue

All issues

Product of the week

Products

Stock list

All quotes

TOP

  • 4SC1.28 EUR10.34%
  • BASILEA110.70 CHF2.31%
  • BIOTEST98.10 EUR2.29%

FLOP

  • PAION2.36 EUR-6.72%
  • MOLOGEN5.45 EUR-4.22%
  • WILEX3.01 EUR-2.90%

TOP

  • CYTOS1.43 CHF320.6%
  • MEDIGENE12.31 EUR189.6%
  • 4SC1.28 EUR64.1%

FLOP

  • MORPHOSYS58.81 EUR-21.3%
  • WILEX3.01 EUR-12.2%
  • BASILEA110.70 CHF-9.4%

TOP

  • SANTHERA93.75 CHF2214.8%
  • FORMYCON26.94 EUR271.6%
  • WILEX3.01 EUR220.2%

FLOP

  • CYTOS1.43 CHF-52.3%
  • MOLOGEN5.45 EUR-52.0%
  • PAION2.36 EUR-35.0%

No liability assumed, Date: 31.03.2015