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Clinuvel Pharmaceutical Development

About Pharmaceutical Regulation

Pharmaceutical products are highly regulated in most countries and need to comply with strict legislative requirements before being authorized for sale. Individual pharmaceutical regulatory bodies in each country are responsible for ensuring the safety and effectiveness of human and veterinary medicines in their jurisdiction, in compliance with local pharmaceutical legislation. In Australia, the regulatory Agency is the Therapeutic Goods Administration (TGA), in the United States the Food and Drug Administration (FDA) and in Europe the European Medicines Agency (EMA). The EMA is responsible for the simultaneous registration of specific types of products…
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About Pharmaceutical Development

Pharmaceutical development is the process by which a drug gets from the lab to the patient as a pharmaceutical product available via a physician’s prescription or over the counter in a pharmacy. Developing a drug for therapeutic benefit is a long, complicated and non-linear process. Genuinely new drugs, that are not derived from a previously examined and approved substance are known as ‘novel’ or New Molecular Entities (NMEs). The task to progress an NME, or any drug, to market today presents many challenges. The evolution of science and medicine has resulted in…
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Good Manufacturing Practice - GMP

GMP is a set of principles and procedures which, when followed by manufacturers of therapeutic goods, food and cosmetic agents, helps ensure that the products manufactured will have the required quality. A basic principle of the code of GMP (cGMP) is that quality cannot be tested into one batch of product but must be built into each batch of product during all stages of the manufacturing process. GMP in Australia To obtain a licence to manufacture therapeutic goods a manufacturer must demonstrate – during an audit – compliance with manufacturing…
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Orphan Drug Designation (ODD) Information

An ‘orphan’ drug is a medicinal product intended to diagnose, treat or cure a rare disease. Orphan drug status is granted by a regulatory body, in a process commonly referred to as Orphan Drug Designation (ODD). This follows review of scientific documentation demonstrating the rarity and severity of the medical condition and the potential benefit of the medicinal product in treating this condition. Because of the financial benefits deriving from obtaining ODD this is generally sought during drug development. The term ‘orphan drug’ was coined in 1983 when the US…
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About Clinical Trials

Clinical trials are formal medical tests of a drug in a clinical setting, such as a hospital, to monitor a drug’s safety profile and effects in humans. Performed under strict regulatory and ethical guidelines, clinical trials form the majority of a drug development program’s time and cost and can involve thousands of patients over many years. The goal of any clinical trial is to determine a drug’s effects on the human body, based on a set of scientific parameters determined prior to the trial, with specific goals established for each…
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Green Pharma

Green pharma is largely based on the study and recommendations put forward in a 1998 publication by Paul T. Anastas and John C. Warner, entitled Green Chemistry: Theory and Practice. The central tenet developed for this new approach to chemistry can be very easily applied to pharmaceutical development and manufacture. Broadly, green chemistry is; …the utilization of a set of principles that reduces or eliminates the use or generation of hazardous substances in the design, manufacture and application of chemical products. In more detail, Anastas and Warner propose twelve principles…
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New Molecular Entity

During research, or ‘drug discovery’ a chemical molecule can be identified as having the potential to be developed into a drug that delivers therapeutic benefit in the form of a treatment or cure for some disease or disorder. New Molecular Entities A New Molecular Entity (NME) or New Chemical Entity (NCE) is a drug or chemical that is without precedent among regulated and approved drug products. The NME designation indicates that a drug in development is not a version or derivative of an existing and previously investigated, trialed and approved…
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Preclinical Testing

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Clinuvel Blog Posts

Inside Clinuvel: Rare diseases day 2013 - rare disea...

Today, February 28, marks Rare Disease Day: an annual event to help highlight the effects of rare diseases on individuals, families and the...

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Q&A: SCENESSE® successful in Phase IIa vitiligo...

We've just released the first results from our vitiligo program which you can view online here. Following their release, we expect a number...

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Inside Clinuvel: Vitiligo and the “Michael Jackson...

I find vitiligo to be a fascinating, yet devastating disorder: almost overnight, patients see their skin colour erode and their identity...

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Clinuvel Webcasts

What can vitiligo patients do? – Lee Thomas and Dr ...

Taking on Vitiligo, a depigmentation disorder of the skin. In 2010, Clinuvel ventured into an area of dermatology where no other pharmaceut...

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The future of vitiligo treatment – Lee Thomas and D...

Taking on Vitiligo, a depigmentation disorder of the skin. In 2010, Clinuvel ventured into an area of dermatology where no other pharmaceut...

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Vitiligo trials of SCENESSE® – Lee Thomas and Dr Ph...

Taking on Vitiligo, a depigmentation disorder of the skin. In 2010, Clinuvel ventured into an area of dermatology where no other pharmaceut...

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Clinuvel Spotlight

Company History

The technology behind Clinuvel’s lead drug, SCENESSE® (afamelanotide), has been in research and development since the 1980s when a small team of scientists set out to investigate methods of preventing skin cancer in humans. Clinuvel licensed this technology and has spent over A$20million optimising the chemistry of afamelanotide (the active ingredient in SCENESSE®) an...

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