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.
29.07.2015 Newly founded Mereo BioPharma has acquired three mid-stage clinical assets from Novartis. In turn, the Swiss pharma concern will hold a stake in the UK company. Other investors are also on board.
24.07.2015 Biotech companies across Europe continue to raise cash on the public markets, generating €3bn in total financing proceedings in the first half of 2015. Compared to 2014, this is almost twice as much.
23.07.2015 US money keeps flowing into Europe's biotechs. As the race for the peanut allergy market heats up, NASDAQ listed French biotech DBV has announced the successful closing of US$281m (€256m) share offering for its allergy products.
16.07.2015 Sanofi has announced plans to restructure its business in five standalone global business units starting in January 2016. The goal is to promote growth and help the company launch a catalogue of new drugs over the next five years.
15.07.2015 GlaxoSmithKline (GSK) has become the first drugmaker to join the Francis Crick Institute. It is a consortium made up of six scientific and academic institutes to conduct research and drug development in the UK. The new institute is set to become a world-leading centre of biomedical research and innovation.
10.07.2015 Karolinska Development has slashed the reported value of its portfolio by almost half by revising its valuation model for early stage companies and divesting its shares in pain med maker Pharmanest.
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