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...
07:00 , Oct 27, 2014 |  BC Week In Review  |  Clinical News

Scenesse afamelanotide regulatory update

EMA's CHMP recommended approval of Scenesse afamelanotide from Clinuvel to treat erythropoietic protoporphyria (EPP), a severe genetic disorder causing absolute ultraviolet radiation and light intolerance in the skin. Scenesse was the first product to be...
00:56 , Oct 25, 2014 |  BC Extra  |  Company News

CHMP recommends Clinuvel's Scenesse

EMA's CHMP recommended marketing authorization under exceptional circumstances for Scenesse afamelanotide from Clinuvel Pharmaceuticals Ltd. (ASX:CUV; Xetra:UR9) to treat phototoxicity in patients with erythropoietic protoporphyria (EPP), a disorder characterized by extreme sensitivity to sunlight. Scenesse...
07:00 , Sep 29, 2014 |  BC Week In Review  |  Clinical News

Scenesse afamelanotide regulatory update

EMA selected Scenesse afamelanotide from Clinuvel for prophylactic treatment of erythropoietic protoporphyria (EPP) as the first product to be included in its pilot project to involve patients in CHMP's assessment of benefits and risks. EMA...
07:00 , Aug 11, 2014 |  BC Week In Review  |  Company News

Clinuvel, Retrophin deal

Clinuvel rejected an unsolicited July proposal from Retrophin to acquire Clinuvel in either a cash or stock deal. The cash deal values Clinuvel at A$92.2 million ($85.6 million) and the stock deal values Clinuvel at...
07:00 , Jun 9, 2014 |  BC Week In Review  |  Clinical News

Scenesse afamelanotide: Phase II started

Clinuvel began the double-blind, placebo-controlled, Singaporean Phase II CUV103 trial to compare 16 mg Scenesse every 4 weeks plus twice-weekly narrow-band ultraviolet B (NB-UVB) light vs. NB-UVB light alone for 7 months in about 60...
07:00 , Jun 9, 2014 |  BC Week In Review  |  Clinical News

Scenesse afamelanotide regulatory update

Clinuvel said it received Orphan Drug designation for its Scenesse afamelanotide in the U.S. and EU to treat Hailey-Hailey disease (HHD), a rare inherited skin disorder characterized by periodic eruption of plaque-like lesions and blisters...
08:00 , Feb 17, 2014 |  BC Week In Review  |  Clinical News

Scenesse afamelanotide: Phase II started

Clinuvel announced the start of a physician-led, open-label, Italian Phase II trial to evaluate 16 mg Scenesse implants every 28 days for 12 months in about 10 patients with HHD (also known as familial benign...