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

BusinessUK

20.08.2014 Biopharmaceutical contract manufacturer Fujifilm Diosynth Biotechnologies is expanding its cell culture manufacturing capacity further with a new 2,000l single-use bioreactor at the company’s site in Billingham, UK.

BusinessEUGermanyUK

15.08.2014 Some of Europe’s biggest pharma companies are competing in a bidding war for US biotech Intermune Inc., Bloomberg reports, citing insider reports as the source.

ResearchEUGermanyUK

13.08.2014 The Ebola epidemic is still raging on in West Africa and thus far there is

neither vaccine nor cure for the viral disease. The only flickers of hope:

an experimental antibody serum and an early-stage vaccine.

BusinessFrance

11.08.2014 Will Sanofi succeed where Pfizer failed? The French pharmaceutical company has taken on the commercialisation of Mannkind Corporation’s inhaled insulin product Afrezza.

ResearchSwedenGermany

08.08.2014 Boehringer Ingelheim is walking away from Swedish Orexo's prostaglandin inhibition project OX-MPI. Germany's largest researching pharmaceutical company had been responsible for the project's research and development since 2005.

ResearchSwitzerlandDenmark

06.08.2014 Roche is re-expanding its involvement in RNAi technologies. The Swiss pharmaceutical company will pay up to €335m for the acquisition of the Danish company Santaris Pharma A/S.

ResearchUKSwitzerland

03.08.2014 In its efforts to become the leading country in genetic research, the UK has attracted investments worth more than £300m (€376m) to map 100,000 human genomes by 2017.

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.

Events

All Events

Current issue

All issues

Product of the week

Products

Stock list

All quotes

TOP

  • SANTHERA80.00 CHF6.74%
  • WILEX2.26 EUR1.80%
  • ADDEX4.07 CHF1.75%

FLOP

  • MOLOGEN7.30 EUR-6.41%
  • 4SC1.16 EUR-3.33%
  • EVOLVA1.27 CHF-2.31%

TOP

  • SANTHERA80.00 CHF15.4%
  • MAGFORCE6.47 EUR9.7%
  • CYTOS0.27 CHF8.0%

FLOP

  • WILEX2.26 EUR-27.6%
  • MOLOGEN7.30 EUR-22.3%
  • 4SC1.16 EUR-20.0%

TOP

  • SANTHERA80.00 CHF3709.5%
  • CO.DON2.50 EUR228.9%
  • PAION2.41 EUR190.4%

FLOP

  • CYTOS0.27 CHF-93.3%
  • MEDIGENE4.60 EUR-68.1%
  • MERCK KGAA64.23 EUR-45.8%

No liability assumed, Date: 21.08.2014