News

FDA rejects Novo’s Tresiba
Enlarge image

RegulatoryDenmark

FDA rejects Novo’s Tresiba

13.02.2013 - The FDA has rejected market authorization of Novo Nordisk’s long-acting insulin Tresiba and demands a complete new cardiovascular safety study.

The FDA asked the Danish insulin-maker to complete a cardiovascular safety study of the long-acting insulin in 7,500 patients before granting market authorisation. The decision on Tresiba comes just a few weeks after the European Medicines Agency had given the green light for the once daily insulin degludec.

 The move of the US regulatory agency came somehow unexpected after its endocrinologics and metabolic drugs advisory panel overcame its initial doubts over the increased risk of stroke and heart attacks and said it would accept a post-marketing study on cardiovascular risk. 

Most analysts don't expect Novo to have databefore 2016, offering market leader Sanofi more years to sell its blockbuster Lantus without a challenge from Tresiba. Sanofi made about 20% of its revenues with Lantus (US$6.6bn) last year – more than 50% of the global diabetes market. The FDA's complete response letter also caught Novo's related Ryzodeg in the regulatory net, which was also backed by the expert panel.

© eurobiotechnews.eu/tg 

http://www.european-biotechnology-news.com/news/news/2013-01/fda-rejects-novos-tresiba.html

AntibodiesDenmarkNetherlands

22.05.2015 Dutch arGEN-X and Danish LEO Pharma are pairing up to develop antibody-based treatments for the chronic inflammation that causes many skin conditions.

M&ANetherlandsGermanyEU

12.05.2015 US pharma is coming to European biotech to fill their pipeline. Pfizer is paying €77.5m for an option on Dutch AM-Pharma, while Juno Therapeutics acquired German biotech Stage Cell Therapeutics for around €72m.

Rare diseasesItalyGermanyPoland

15.05.2015 Rome-based pharmaceutical group Sigma-Tau has sold its blood cancer drug programme Oncaspar to US company Baxter, who aims to spin out its biopharma business.



SurveyGermany

06.05.2015 More revenue, more staff, more funding: in the German biotech industry, all signs are pointing towards growth.

M&AUKSweden

18.05.2015 Double deal for allergy: UK’s speciality biopharma Circassia is boosting its asthma pipeline with the acquisition of Swedish asthma specialist Aerocrine as well as fellow British Prosonix.

FinancingUK

20.05.2015 The Scottish Government has announced it will double the amount of funds for rare diseases. The New Medicines Fund that was created last year for this purpose will be increased to £80m (€112m).

M&ASwitzerland

04.05.2015 Swiss crop chemical maker Syngenta AG is in talks with US company Monsanto to discuss a possible merger, insiders say.

BiofuelsEU

30.04.2015 The European Parliament has given the go-ahead on a new law limiting the use of harmful crop-based biofuel in the transport sector. The decision marks a breakthrough in the EU’s approach to biofuels.

FinancingSwitzerlandUK

29.04.2015 Biopharma start-up CRISPR Therapeutics has raised US$64m to hurry the new CRISPR/Cas9 technology to the clinic.

Events

All Events

Partner-Events

Frankfurt am Main (DE)

ACHEMA 2015

Current issue

All issues

Product of the week

Products

Stock list

All quotes

TOP

  • EVOTEC4.06 EUR4.10%
  • VITA 345.72 EUR3.06%
  • SARTORIUS165.00 EUR2.77%

FLOP

  • CYTOS0.65 CHF-4.41%
  • WILEX4.06 EUR-4.02%
  • CO.DON2.80 EUR-3.78%

TOP

  • 4SC4.61 EUR274.8%
  • SYNGENTA422.10 CHF29.1%
  • WILEX4.06 EUR26.9%

FLOP

  • CYTOS0.65 CHF-36.3%
  • MEDIGENE9.02 EUR-31.1%
  • BIOTEST76.17 EUR-22.3%

TOP

  • WILEX4.06 EUR401.2%
  • CYTOS0.65 CHF364.3%
  • 4SC4.61 EUR319.1%

FLOP

  • MOLOGEN4.89 EUR-54.7%
  • BIOFRONTERA2.30 EUR-24.1%
  • CO.DON2.80 EUR-23.7%

No liability assumed, Date: 21.05.2015