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CLINUVEL's company releases, including archives.

Wednesday, 07 October 2015 17:04

Form 604 - October 7, 2015

In accordance with ASX listing rules 3.13.1 and 14.3, Clinuvel Pharmaceuticals Limited (ASX: CUV; XETRA-DAX: UR9; ADR: CLVLY) today announced it will hold its 2015 Annual General Meeting of shareholders on Tuesday November 24, 2015 at 10.00am AEST at Karstens Conference Centres, Level 09, 123 Queen Street, Melbourne, Victoria, Australia 3000. A formal Notice of Meeting and the Company’s Annual Report will be lodged with the ASX no later than October 23, 2015. - End - Media enquiries Lachlan Hay, Clinuvel (UK) Ltd. +44 1372 860 765 This email address is being protected from spambots. You need JavaScript enabled to view it. Nick Miles, Cabinet Privé de Conseils s.a. +41 22 321 4540 This email address is being protected from spambots. You need JavaScript enabled to view it.
Type C meeting provides guidance for follow up and further discussions between FDA and Clinuvel Leatherhead, UK and Melbourne, Australia, October 5, 2015 Clinuvel Pharmaceuticals Limited (ASX: CUV; ADR:CLVLY; XETRA:DAX) today announced that on September 30 it met in Silver Spring, USA, with the US Food and Drug Administration’s (FDA’s) Division for Dermatology and Dental Products (DDDP) and representatives of the Center of Drug Evaluation and Research (CDER). The objective of the meeting was to discuss the US regulatory review of SCENESSE® (afamelanotide 16mg) to be made available to American erythropoietic protoporphyria (EPP) patients. In 2014 SCENESSE® was granted marketing…
Thursday, 27 August 2015 17:32

FDA grants Clinuvel a Type C Meeting

Discussion on US pathway to marketing approval for SCENESSE® Clinuvel Pharmaceuticals Limited (ASX: CUV; ADR:CLVLY; XETRA:DAX) today announced that it will meet the US Food and Drug Administration (FDA) to discuss the overall development of SCENESSE® (afamelanotide 16 mg) and the filing requirements for a New Drug Application (NDA) for the treatment of adult patients diagnosed with erythropoietic protoporphyria (EPP; absolute light intolerance).BACKGROUNDClinuvel has been in regular dialogue with the FDA throughout the SCENESSE® development program. The FDA’s Office for Orphan Products Development designated SCENESSE® as an orphan drug for EPP in 2008. Orphan drug designation recognises the potential of…
Wednesday, 23 September 2015 17:48

Form 603 - September 23, 2015

Monday, 21 September 2015 16:03

SCENESSE® released for European Distribution

Pharmacovigilance Risk Assessment Committee reviews Post Authorisation Safety Study [PASS] Clinuvel Pharmaceuticals Limited (ASX: CUV; ADR:CLVLY; XETRA:DAX) announces today that the European Medicines Agency’s (EMA’s) Pharmacovigilance and Risk Committee (PRAC) has agreed to a Post Authorisation Safety Study (PASS) protocol, allowing SCENESSE® (afamelanotide 16mg) to be released for the commercial supply to adult patients diagnosed with erythropoietic protoporphyria (EPP). While SCENESSE® was granted European marketing authorisation by the European Commission on 22 December 2014, it has taken a further nine months to gain agreement on the proposed PASS protocol.PHARMACOVIGILANCEAs part of the marketing authorisation, Clinuvel and the EMA agreed upon…
Friday, 31 July 2015 15:55

Appendix 4C - Q4 FY15

Thursday, 30 July 2015 18:14

Form 605 - July 30 2015

Wednesday, 15 July 2015 17:12

Clinuvel Newsletter - July 2015

Breakthrough treatment for orphan genetic disorder presented to the general medical community EXECUTIVE SUMMARY SCENESSE® published as innovative treatment in erythropoietic protoporphyria (EPP) Combined analyses of Phase III studies show significant improvement in the duration of patient sun exposure without phototoxicity New England Journal of Medicine: highest “impact factor” medical journal Pivotal studies led to December 2014 European marketing authorisation Melbourne, Australia and Leatherhead, UK Clinuvel Pharmaceuticals Ltd (ASX: CUV; XETRA-DAX: UR9; ADR: CLVLY) today announced that results from its pivotal Phase III studies of SCENESSE® (afamelanotide 16mg) in the orphan genetic disorder erythropoietic protoporphyria (EPP) have been published in…

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