Welcome to 2010 with Clinuvel

Friday, January 29th, 2010

The coming 12 months will prove significant for Clinuvel as we anticipate the flow of communication and news to increase. As part of our preparation for upcoming developments and to ensure we are well placed to face the challenges unique to reaching our clinical, regulatory and business objectives, we’ll be making some changes to our online communication channels.

In the coming weeks we will be updating elements of our online presences and this may result in some downtime for our various websites and inevitable bugs and consequent troubleshooting exercises.

If you have any input or ideas as to how we could improve the corporate or photoprotection websites, the Clinuvel blog or Twitter feed please feel free to leave a comment on this post. We’ll consider all suggestions and are looking forward to your input.

We apologise in advance for any inconvenience experienced during this time and hope you benefit from the updates and developments we are implementing.

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News from the FDA’s public hearing on internet promotion of drugs

Tuesday, December 1st, 2009

newyork_2Last month saw the conclusion of the FDA’s public hearing on the internet promotion of drugs. This was the first time the agency has directly addressed and engaged key stakeholders in regards to online policy and guidelines since 1996, when the 16.7% of Americans who had web access spent an average of 30 minutes online each month.

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Follow the Clinuvel AGM on Twitter

Friday, November 13th, 2009

townhallAs you know, the Clinuvel AGM is fast approaching (18th November) in Melbourne, Australia. While we are inherently an Australian company, we recognise that there are a substantial number of stakeholders worldwide who are interested in our news and developments.

In recognition of this fact we will be ‘livetweeting’ updates from the AGM under the hashtag #CUVAGM.

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Talking off the label – part one

Sunday, October 25th, 2009

prescription_labelToday, and in the coming weeks I shall review the increasingly complex phenomenon in the pharmaceutical industry called off-label drug use.

In February 2008, the FDA issued a statement in which it said that it “recognises that the public health can be served when healthcare professionals receive truthful and non-misleading scientific and medical information on unapproved uses of approved or cleared medical products”. Senator Henry Waxman (Democrat), chairman of the House of Representatives Energy and Commerce Committee, implied that the Bush administration had given drug companies a long desired “parting gift”.

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FDA’s public hearing on internet promotion of drugs

Friday, October 16th, 2009

wiresWhile we firmly believe at Clinuvel that communication and online dialogue is a most valuable tool to inform shareholders, prospective patients and physicians, the boundaries of drug promotion are being drawn as we speak.

When it comes to marketing and selling drugs, digital media present the lifescience industry with a plethora of new opportunities. However, the traditional principles of good practice in pharma still apply. In other words, the same guidelines and regulations need to be used when deciding to promote products online. Regulators seem to have followed suit and closely look at online announcements and interpret wording carefully. The best case is presented by the US FDA issuing warnings earlier this year to 14 major pharmaceutical companies in relation to fair balance language and paid search activities.

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GMP – Good Manufacturing Practice makes perfect

Wednesday, October 14th, 2009

beakersManufacturing drugs for human use is a complicated process frequently involving compounds and materials that, if used incorrectly, can be hazardous to people’s health. Highly regulated nations (such as the US, EU, Australia and Canada) have long realised the necessity that they develop strict guidelines governing these processes to protect patients and ensure product safety, quality and efficacy. Poor quality drugs, manufacturing processes or conditions can have extreme and dire consequences for patients. In countries that enforce Good Manufacturing Practice (GMP) the penalties for non-adherence reflect its importance and can include forcing worldwide product recalls, seizure of property, large fines, even imprisonment.

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Green pharma and the path to sustainable, responsible drug development

Friday, September 18th, 2009

earth_2A most interesting movement that’s gathering steam within pharmaceutical development is that of Green Pharma.

The concept began in Germany and Sweden, home to many environmentally and socially aware initiatives. Simply put, Green Pharma is the practice of considering the broader implications and consequences of the entire process of drug development and striving to ensure that when a drug gets to market it can be considered benign by design.

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New media communication and the effects on pharmaceuticals

Friday, September 4th, 2009

Photoart_0117The millisecond transfer of data packs has changed medicine for good. When it comes to gaining online information about our health the pros outweigh the cons. We are seeing in modern medicine that patients are well prepared when seeking health consultation. Sites such as eMedicine, YahooHealth and the Dermdoctor contribute to our deeper understanding of medicine. The endless flow of free information will certainly have its effect on drug development too, but the lack of direct contact between the pharmaceutical company and its end-customers traditionally forces drug developers to primarily focus on the prescriptive behaviour and needs of physicians.

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Clinuvel’s regulatory strategy – Dr Hank Agersborg

Monday, August 31st, 2009

sidebar_podcastDr. Hank Agersborg is Clinuvel’s Chief Scientific Officer. With over 50 years working in the industry, his insights and experience span some of the most dynamic and exciting eras of change and evolution that this sector has seen.

In this interview he discusses the company’s regulatory strategy following the announcement of a confirmatory Phase III EPP study.

Click here to listen or download.

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Light, life’s invisible paradox

Friday, August 28th, 2009

Photoart_0117During more than a decade of clinical research on Clinuvel’s proprietary drug afamelanotide, our teams have specialised in, and focused on, the study and importance of light absorption for our health and well-being.

However, light is regarded as an ‘optical paradox’: too little may result in vitamin D deficiency or seasonal affective disorder (SAD), while too much may result in skin cancer. In seeking answers from related fields, our in-house scientists often remark that human biology is unfortunate to lack green chlorophyll with its ability to efficiently process light into nutrition.

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