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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

Study sheds light on common skin cancers...

“Basal cell carcinoma skin cancer is the most common form of skin cancer”. It’s a common claim and one which is undoubtedly true –...

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Delivering a therapy for those who need it most: EPP...

Earlier today we announced that two health insurers in Switzerland had agreed to reimburse SCENESSE® (afamelanotide) for the rare disease...

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New UK coins may pose skin allergy risk...

In a letter published this week in the British Journal of Medicine three dermatologists have highlighted the potential risks posed by the...

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Clinuvel Webcasts

Understanding Vitiligo: Misconception & Myth...

Vitiligo is a skin disorder which causes the loss of pigment - melanin - in the skin. Though it affects around 45 million people worldwide,...

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'Check up' reports on rare disease EPP and SCENESSE...

On 31 January 2012 Swiss TV channel Telezueri aired a report on erythropoietic protoporphyria (EPP), a rare genetic disorder which causes ab...

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"Focus really pays off in the end"...

Following Clinuvel's landmark filing of a marketing authorisation application for the drug SCENESSE® (afamelanotide) with the European Medic...

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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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