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

GenericsEUUKHungaryGermanyItalyGreeceAustriaLuxembourgFranceSpain

26.02.2015 It is the first biosimilar monoclonal antibody in many European markets: Mundipharma and Hospira are launching Celltrion’s Remicade generic.

M&AUK

23.02.2015 British drug developer Heptares has been acquired by Japanese biopharma play Sosei for US$400m (€352m).

bioethanolGermanyUKBelgiumFrance

19.02.2015 The price of oil has been sliding for months, and the European bioethanol market is taking it hard. CropEnergies AG has now stopped production at its British unit Ensus UK.

BusinessFranceGermany

17.02.2015 After Christopher Viehbacher’s unceremonious ousting last year, Sanofi has been on the look out for a new CEO. Now, sources say Bayer’s Olivier Brandicourt is set to fill the position.

BusinessUKSwitzerland

12.02.2015 Glaxosmithkline is intent on bolstering its vaccine portfolio further and has bought all shares of Swiss development partner Glycovaxyn.

InvestmentsUKEU

10.02.2015 Interest in biotechnology is on the rise among British investors. Not just one, but two major financiers are planning investment funds in the field.

IVFUKEU

04.02.2015 In a historic move, the UK is set to become the first country to allow the creation of babies with the genetic material of three people – a mother, a father and a female mitochondrial donor.

Events

All Events

Partner-Events

Planegg/Martinsried

1st Munich Biotech Pitch

Berlin (DE)

Proteomic Forum 2015

Current issue

All issues

Product of the week

Products

Stock list

All quotes

TOP

  • 4SC0.78 EUR0.00%
  • ACTELION114.40 CHF0.00%
  • ADDEX3.20 CHF0.00%

FLOP

  • CYTOTOOLS31.45 EUR-0.47%
  • 4SC0.78 EUR0.00%
  • ACTELION114.40 CHF0.00%

TOP

  • WILEX3.43 EUR75.0%
  • BASILEA122.20 CHF16.9%
  • FORMYCON16.70 EUR16.8%

FLOP

  • SANTHERA94.55 CHF-10.4%
  • STRATEC BIOMEDICAL43.49 EUR-7.5%
  • BIOFRONTERA1.84 EUR-5.6%

TOP

  • SANTHERA94.55 CHF2330.6%
  • WILEX3.43 EUR481.4%
  • FORMYCON16.70 EUR106.7%

FLOP

  • CYTOS0.34 CHF-88.7%
  • MOLOGEN5.38 EUR-55.7%
  • BIOFRONTERA1.84 EUR-53.3%

No liability assumed, Date: 27.02.2015