Viewpoint: the case for stricter reimbursement rules

The drug regulatory system is directed towards the approval of new medicines for particular uses, based on clinical trials and other evidence that the product is effective and safe. Yet, once approved, it is in most jurisdictions possible for a doctor to prescribe the product for whatever use s/he sees fit. This is in accordance […]

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Viewpoint: the case for longer drug exclusivity

I have dealt in the past with an analysis of the decline in patent-based drug exclusivity, pointing out that data exclusivity is becoming increasingly important. However, the time has come to raise the issue more broadly: the case for longer terms of commercial protection, in the interests of better medicines should be heard.

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Seven Surprising Facts About Biogen-Idec’s Developmental ‘Blockbuster’ for Multiple Sclerosis

The recent news from Biogen-Idec of the success of their experimental drug BG-12 for relapsing-remitting multiple sclerosis is in many ways remarkable. Although BG-12 is not approved yet, here are seven things about it which challenge many of the widely held beliefs about how we should best discover drugs today.

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Novelty

Bruce Booth, who writes an informative and insightful blog about early stage life science venture capital, posts regularly about trends within the biotech industry, and recently about expectations for 2012.  It seems the primary theme from this year’s Annual J.P. Morgan conference is innovation. Before going further, this requires some analysis. Innovation, a.k.a. Novelty, means […]

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Retrospective Analysis of Clinical Trials

Last week David Cameron, the British Prime minister, announced a new policy to make available the data from National Health Service prescriptions in order to promote better new medicines discovery. I wonder if he had read an article published in Drug Discovery Today and available online from October 2011, wherein we say essentially the same […]

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Non-commercial drug repurposing for improved health outcomes

On 7th December 2010, we saw the release of important clinical information supporting the benefit of aspirin in preventing colorectal and other cancers. Truly, aspirin is a charmed drug. One of the oldest known therapeutics, this is now the third substantial therapeutic effect of the compound: first pain, then cardiovascular disease (stroke, myocardial infarction) and […]

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Data exclusivity for biologics: no longer a level playing-field

Behind the headline of universal healthcare resulting from the recent Obama administration reforms, lies the simultaneous change to the regulation of biologic drugs imposed by the new legislation. The change concerns the data exclusivity period and process for follow-on biologic approval by the FDA. The Approval Pathway For Biosimilar Biological Products, provides clarity on an […]

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