News

EU approves Signifor from Novartis
Enlarge image

BusinessSwitzerlandUK

EU approves Signifor from Novartis

26.04.2012 - Novartis has gained EU marketing approval for the first targeted therapy to treat Cushing’s disease, a rare endocrine disorder.

Basel – Swiss pharma major Novartis has got the green light from the European Commission to market Signifor (pasiretoid) as treatment for Cushing disease, a debilitating endocrine disorder caused by the over-expression of cortisol. Data from a Phase III trial on 162 patients with the disease showed that subcutaneous injection of the somatostatin analogue twice daily normalised the level of cortisol in the urine („urinary-free cortisol, UFC“) by 47,9% after six months of treatment (N Engl J Med. 2012 Mar 8;366(10):914-24).  Clinical symptoms such as high blood pressure, high BMI and cholesterol levels and overweight in the two dosage groups (2 x 600µg and 2x 900 µg) significantly improved after administration of the orphan drug. About 250,000 people in the EU suffer from the disease. In two thirds of them, the disorder is caused by so-called pituitary tumours that release the corticoid hormone ACTH which then triggers cholesterol over-expression.  Signifor is approved for adult patients with inoperable pituitary tumours. It reduces ACTH levels by targeting the somatostatin receptor 5 with 40-fold higher affinity as any other somatostatin analogue. In January 2012 the European Medicines Agency in London had recommended approval of Signifor as first-in-class treatment for Cushing’s disease.

http://www.european-biotechnology-news.com/news/news/2012-02/eu-approves-signifor-from-novartis.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.



BiologicsFinlandNetherlandsEU

26.05.2015 The Finnish Medicines Agency Fimea has joined the Dutch MEB in its stance on the interchangeability of biosimilars. The Fimea now sees physician-driven switching of biologics as unproblematic.

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.

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

  • MEDIGENE8.76 EUR2.10%
  • EPIGENOMICS5.31 EUR1.53%
  • MOLOGEN4.99 EUR1.42%

FLOP

  • SARTORIUS160.55 EUR-5.36%
  • STRATEC BIOMEDICAL46.74 EUR-3.67%
  • WILEX4.05 EUR-3.57%

TOP

  • 4SC4.66 EUR258.5%
  • SYNGENTA421.00 CHF27.3%
  • BASILEA134.80 CHF15.3%

FLOP

  • CYTOS0.62 CHF-42.6%
  • MEDIGENE8.76 EUR-29.4%
  • WILEX4.05 EUR-16.3%

TOP

  • WILEX4.05 EUR412.7%
  • 4SC4.66 EUR298.3%
  • FORMYCON27.20 EUR296.5%

FLOP

  • MOLOGEN4.99 EUR-53.8%
  • BIOFRONTERA2.30 EUR-25.8%
  • CO.DON2.85 EUR-22.6%

No liability assumed, Date: 26.05.2015