07:00 , Sep 28, 2015 |  BC Week In Review  |  Clinical News

Scenesse afamelanotide regulatory update

Clinuvel said that EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has agreed to a post-authorization safety study (PASS) protocol, which now allows the company to launch Scenesse afamelanotide to treat erythropoietic protoporphyria (EPP). The PASS protocol...
08:00 , Feb 16, 2015 |  BC Week In Review  |  Clinical News

Scenesse afamelanotide regulatory update

In December, the European Commission approved under exceptional conditions Scenesse afamelanotide from Clinuvel to prevent phototoxicity in patients with erythropoietic protoporphyria (EPP), a severe genetic disorder causing absolute ultraviolet radiation and light intolerance in the...
08:00 , Nov 17, 2014 |  BC Week In Review  |  Company News

Clinuvel, Biotech Lab Singapore deal

Clinuvel and Biotech Lab Singapore formed a JV to develop pediatric formulations of Clinuvel's Scenesse afamelanotide ( CUV1647 ) and CUV9900 . Clinuvel will lead and oversee regulatory development, while Biotech Lab Singapore will manage...