Inside Clinuvel
The last five years have brought much change in the global pharmaceutical industry. As one of thousands of firms working in the space, we’ve taken a novel approach to try and overcome the challenges...
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Inside Clinuvel: effective drug development
Take ten years, half a billion dollars and countless man hours from some of the most highly trained, intelligent individuals on the globe. You still stand a 90% chance of failure, some of which is...
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Inside Clinuvel: SCENESSE® in acne?
A new article was published last week looking at a small pilot study of SCENESSE® (afamelanotide) in acne vulgaris. Before discussing this piece specifically, I think it is relevant to briefly review...
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Inside Clinuvel: Vitiligo and treatment frustrations
Since we publicly announced our vitiligo program in 2010, the entire Clinuvel team has aimed to gain a better understand this disease, its possible causes and how SCENESSE® (afamelanotide) may become a...
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Inside Clinuvel: NICE, QALYs and the UK’s reimbursement landscape
Following much hype and fanfare at the Olympics, news reports have begun to trickle out on the costs of the Games and the longer term impact they might have on the British economy. While not immune to...
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Inside Clinuvel: EMA timelines and orphan drugs (part 1)
For many years we’ve taken an active interest in the time required by regulatory authorities globally to approve orphan drugs. Clearly this kind of activity is required for forecasting and planning,...
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Inside Clinuvel: EMA timelines and orphan drugs (part 2)
Last week I gave a snapshot of the formal process undertaken by the European Medicines Agency (EMA) to review a Marketing Authorisation Application (MAA) dossier under the Centralised Procedure. While...
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Inside Clinuvel: Vitiligo and the “Michael Jackson skin disease”
I find vitiligo to be a fascinating, yet devastating disorder: almost overnight, patients see their skin colour erode and their identity change. Vitiligo has a serious impact on individuals and their...
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Inside Clinuvel: Rare diseases day 2013 – rare diseases across borders
Today, February 28, marks Rare Disease Day: an annual event to help highlight the effects of rare diseases on individuals, families and the community, and to raise awareness in the hope of finding...
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Inside Clinuvel: Porphyrins & Porphyrias 2013
The biennial Porphyrins & Porphyrias conference is the only international meeting of global key opinion leaders on the group of diseases known as porphyrias. Convening last week (15-19 May) in...
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