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.
26.11.2015 Bioeconomy movers and shakers from every corner of the globe met this week at the world’s first Global Bioeconomy Summit in Berlin to discuss, debate and define better ways to ensure the bioeconomy succeeds on an international level.
24.11.2015 After weeks of speculation it is official: US pharma major Pfizer and Irish Botox maker Allergan will merge. With the deal, Pfizer is planning to dodge the high US taxes, causing indignation among US politicians.
23.11.2015 Amidst talk of the IPO window closing and cancelled flotations, diagnostics firms are still striking a chord with investors. Swedish Immunovia and German Curetis are successfully raising public money.
17.11.2015 The first Italian accelerator specifically for biotech projects has been launched with help from Sofinnova Partners. The plan of BiovelocITA: to help Italy grow into one of Europe’s strongest biotech markets.
13.11.2015 Scientists in Bath, UK, have developed a medical dressing that turns fluorescent green when it detects infection. The researchers hope that the smart burns dressing will help fight antibiotic resistance.
13.11.2015 Out with the old: Roche is discarding four sites with 1,200 staff in an effort to restructure its manufacturing network for small molecules. Instead, a new manufacturing site will be built in Switzerland.
10.11.2015 Algae have many skills, but cancer fighting was not one of them – until now. Researchers from Australia and Germany have genetically engineered diatom algae to accurately deliver chemotherapeutic drugs.
10.11.2015 AstraZeneca has plucked Californian biopharma company ZS Pharma from under Actelion’s nose. The UK company is paying US$2.7bn (€2.5bn) to acquire ZS and its promising hyperkalaemia treatment currently under US regulatory review.