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

BusinessIreland

07.07.2015 Irish pharma play Allergan plc. is boosting its eye care business by acquiring US-American medtech company Oculeve. Included in the deal are Oculeve’s dry eye disease development programmes.

BusinessSwitzerland

03.07.2015 Biotech giant Biogen is investing CHF1bn in a new pharmaceutical production plant in the Swiss town of Luterbach. Noted as one of the world’s oldest biotech firms, Biogen will create up to 400 jobs at the new plant.

R&DNetherlandsSpainAustria

02.07.2015 Dutch biotech Amarna and Austrian Biomarker research centre CBmed have joined forces to develop several immunotherapies, including therapies against cancer and diabetes type 2. The joint venture will develop Amarna’s next generation viral vector platform.

M&ASwitzerland

30.06.2015 Pharma giant Novartis has bumped up its neuroscience portfolio with the recent purchase of Australian biotech Spinifex for a US$200m upfront payment plus US$500 in milestone payments. The acquisition is centred on Spinifex’ mid-stage pain drug EMA401.

Personalised MedicineGermany

25.06.2015 German immunotherapy expert BioNTech AG has partnered up with Europe’s largest engineering company Siemens to construct a manufacturing site for BioNTech’s personalised cancer vaccine.

Bioelectronic researchSweden

24.06.2015 Swedish scientists have created artificial neurons that are capable of mimicking the function of human nerve cells. The researchers hope that, once minituarised, they may one day be used to restore disturbed neural function.

FinancingLuxembourgItalySwitzerland

23.06.2015 Cosmo Pharmaceuticals is floating its majority-owned subsidiary Cassiopea at the Swiss Stock Exchange, with the aim to raise between CHF150m and CHF200m.

EventEUGermany

22.06.2015 For the 31st time, the ACHEMA has drawn the global chemical engineering and the process industry to Frankfurt. Although still overshadowed by petrol, the biobased economy is getting ready to step out into the limelight.

EventEU

17.06.2015 At the BIO convention in Philadelphia, the biotech industry celebrates new gene and cell therapies, and hails its unlikely superheroes.

ResearchUKSwitzerland

16.06.2015 Northern Ireland’s biopharma Almac Discovery is partnering up with Roche subsidiary Genentech in a two-year joint research programme to discover and develop cancer treatments.

Events

All Events

Current issue

All issues

Product of the week

Products