Clinuvel Non-Executive Director Jack Wood discusses the selection of SurModics Inc as Clinuvel’s first commercial manufacturing partner for SCENESSE®. Click here to listen.
Jack Wood discusses Clinuvel’s manufacturing partner for SCENESSE®
Friday, July 9th, 2010Necessary innovation: the vital role of manufacturing in pharmaceutical development
Thursday, July 8th, 2010
This morning Clinuvel announced a significant milestone in its development program for SCENESSE®: the signing of the first manufacturing agreement for the final drug product with SurModics, Inc., a leading provider of drug delivery technologies to the healthcare industry. It has taken over eight years for Clinuvel to reach this milestone. In this time, the company has refined SCENESSE’s active ingredient – afamelanotide – and arrived at a final injectable drug product which controls its release to achieve an optimal photoprotective response in patients.
Under your skin: Sunscreen and skin cancer this summer
Thursday, June 24th, 2010
With the northern Hemisphere officially creeping into summer, the first arguments of this season’s sun and skin debate have arisen
Anti cancer councils and organisations akin to Australia’s Sunsmart are continuing their awareness-raising campaigns, educating the public about the issue, and most importantly the practice of sun protective behaviour; although significant investment and persistence are required, well executed and long running campaigns can make significant progress, albeit on a regional scale. But a vocal group of skeptics are continuing to question whether a central element, sunscreen, might just be part of the problem.
Orphan drug development legislation and regulation landscape
Monday, May 17th, 2010
Previously we have discussed the shifts which take place in the regulatory centers of the world specifically London and Maryland, which present an opportunity to the industry to respond to expressed need. Perhaps the greatest concern of every individual is access to health and quality of life.
This implies a strong directive for drug developers to respond to the identified needs of the patients and patient communities. But amongst those with therapeutic needs are some with more unaddressed medical requirements: patients with ‘orphan’ diseases.
Orphan diseases are rare and frequently untreated diseases. The previously referred shift towards patient driven drug development made a few voices heard and legislators in the European Community and United States started to act on behalf of the population. Here the legislators and regulators provided incentives to drug developers by reducing fees, providing exemptions and protection from competitors.
Patient driven drug development
Monday, May 17th, 2010
Pharmaceutical development is undergoing a defining shift following the ever-increasing regulatory rigor in the process of evaluating a new product. Our recent announcement reflects the conservative view we hold on 21st century drug development.
During development the innovator often seeks to create a market for the new product, a common concept applicable to various industries. The same holds true for afamelanotide: we identified and developed our lead product in an under-served market of porphyria. Adaptation to chemistry and technology, novel communication platforms, deep knowledge and relationships with academia facilitated today’s entry to market.
FDA Basics: new website launched
Wednesday, January 13th, 2010Overnight the US FDA launched a new website called “FDA Basics” – a site intended to improve the agency’s transparency and help educate the public on the tasks undertaken by the FDA. This is the first initiative to come out of the new Transparency Task Force, formed when a new administration took over the FDA last year.
The agency has taken a three pronged approach to the website, offering public Q&A, short videos on its activities and conversations with FDA staff on their roles and responsibilities. The site is a little light on content at present but, interestingly, is relying primarily on public feedback and input to help it grow.
News from the FDA’s public hearing on internet promotion of drugs
Tuesday, December 1st, 2009
Last 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.
The Clinuvel AGM
Tuesday, November 24th, 2009
As many of you may know, this week saw Clinuvel hold its Annual General Meeting in the Melbourne Town Hall. As managing director I welcome these opportunities where I am able to meet and talk to the people whom Clinuvel considers integral to the company and its existence; the Board of Directors sees Clinuvel’s investors as unique. In Clinuvel, an investor has to fundamentally believe in the premise of offering pharmaceutical photoprotection, a novel option, an innovative approach to skin disorders.
In a meeting that would be considered short by international standards I was both excited and proud to present some of the achievements and milestones our team has reached this year, and lay out our plans for the next 12 months.
Orphan drug designation (ODD) – recognising rare, severe diseases
Tuesday, November 10th, 2009
In January 1983 the United States government passed an Act that has had a profound impact on pharmaceutical development and the individuals whom it was intended to benefit. The Orphan Drug Act (ODA) was lobbied for successfully by the National Organisation for Rare Disorders (NORD) and provides incentives for researching and developing treatments for rare or ‘orphan’ diseases.
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Talking off the label – part three
Friday, November 6th, 2009
Allergan’s lawsuit filed against the FDA presents a relatively novel case in addressing the requirements of drug developers in relation to off-label use of drugs by physicians.
Allergan may be one of the many companies to follow suit in time. Allergan’s concern is the FDA’s stance – prohibiting communication to the medical community in regards to the common off-label uses of Allergan’s lead product – poses a violation of the first amendment rights under the US constitution. A pharmaceutical company should be able to exercise its rights under freedom of speech to provide truthful and relevant information to its users: physicians.
