1. Pink Sheet
  2. >>Archive

INTERVIEW: Clinuvel's Scenesse and the patient factor in drug assessments

 
• By Ian Schofield

Not many pharmaceutical executives would take credit for helping to steer the European Medicines Agency in a particular direction when it comes to assessing new innovative medicines. But that's what Philippe Wolgen, CEO of the Australian rare diseases company Clinuvel, claims to have achieved when he decided to seek EU approval for the ground-breaking phototoxicity drug Scenesse with the close involvement of patients and physicians.

Not many pharmaceutical executives would take credit for helping to steer the European Medicines Agency in a particular direction when it comes to assessing new innovative medicines. But that's what Philippe Wolgen, CEO of the Australian rare diseases company Clinuvel, claims to have achieved when he decided to seek EU approval for the ground-breaking phototoxicity drug Scenesse with the close involvement of patients and physicians.

Scenesse, an orphan drug containing afamelanotide, was approved by the European Commission in December 2014 for the treatment of adults with erythropoietic protoporphyria (EPP), a rare genetic disorder characterized by

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Archive

Ocaliva: Still No Clarity On Why EU Court Opposed Revocation Of Approval

 
• By Neena Brizmohun

Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.

Final Chance To Have Your Say: Take Our Reader Survey This Week

 
• By Nielsen Hobbs

This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.

Shape Our Content: Take The Reader Survey

 
• By Nielsen Hobbs

We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in coverage topics, article format, or the method in which you access the Pink Sheet – or if you love it how it is – now is the time to have your voice heard.

Brazil Pilots Digital Drug Pack Inserts

 
• By Francesca Bruce

A new pilot aims to take Brazil closer to ‘digital transformation.’

More from Pink Sheet

EU Shaping Biotech Act To Unleash SME Potential

 
• By Neena Brizmohun

European companies, in particular small and midsize enterprises, spin-offs and start-ups have a hard time expanding within the single market “because of a complex regulatory framework that is perceived as slow and burdensome,” according to the European Commission.

New EU Filings

 
• By Neena Brizmohun

Brensocatib, Insmed's investigational treatment for non-cystic fibrosis bronchiectasis, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.

‘Tectonic’ Arkansas PBM Legislation May Upend Industry

 
• By Tim Casey

Industry will fight hard to prevent other states or the federal government from adopting measures similar to Arkansas' law preventing PBMs from owning pharmacies.