Commentaries

21 September 2015

Why does use of expedited approval methods vary so greatly? An analysis of orphan drugs approved in 2014

The Journal of Rare Disorders - Why does use of expedited approval methods vary so greatly - An analysis of orphan drugs approved in 2014 (21Sept2015).jpg21 September 2015: No less than 17 orphan drugs were approved by the FDA last year. They all benefited, though to varying extents, from at least one of the four different methods the FDA offers for expediting new drug approval. In their new article for The Journal of Rare Disorders, TranScrip's John Ansell and Glenn Tillotson analyse the stats the FDA issued on all new drugs it approved in 2014. They found remarkable variation in the extent to which the companies submitting orphan drugs had utilised the four different methods. And even though the 17 companies were successful, Ansell & Tillotson were able to deduce that the FDA methods aren’t being used optimally by them.The authors propose that Priority Review, one of the four methods, should now granted automatically for orphan drugs. They also believe it is now time for the FDA to rationalise and unify the four methods of expedited approval. This would benefit developers of all types of drugs, but particularly of orphans. Also, in reducing duplication of FDA effort, this should reduce the resources it needs; this is particularly important at a time when the number of applications it will have to deal with is projected to rise significantly.

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18 June 2015

Value based pricing and cancer drugs – a continuing saga by TranScrip’s Senior Academic Partner, Karol Sikora

Karol Sikora commentary 18Jun2015.jpgThere has been an explosion in the cost of cancer drugs and the price range is frightening – treatment for a month can cost anywhere between £10 and £12,000. There has never been a clear relationship between drug cost and its ability to prolong survival but costs have now escalated to such massive amounts that no health-care system – tax, insurance or self-pay - can take the pressure.

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04 June 2015

To target or not to target? That is the question – TranScrip’s Linda Summerton reports from ASCO, Chicago 2015

To-target-or-not-to-target.png4th June 2015: Presentations on the clinical data for the two marketed PD1 inhibitors (nivolumab; Opdivo; BMS) and pembrolizumab; Keytruda; Merck), as expected, were everywhere at ASCO, being proclaimed as new standards of care in melanoma, both squamous and non-squamous non-small cell lung cancer (NSCLC) and with significant response rates in many other Phase II cancer trials.

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18 March 2015

Expanding geographical scope for your development can substantially increase the chances of investment or finding a pharma partner or acquirer

2015-03-17-Expanding-Geographical-Scope-for-Your-Development-Programme-Can-Substantially-Increase-the-Chances-of-Investment-or-Finding-a-Pharma-Partner-or-Acquirer_Page_1-e1426690459160.jpg18th March 2015: Are you are a small biotechnology company with an exciting potential new treatment in exploratory clinical development and considering your next steps? Keeping your clinical development local has its attractions: you know the clinicians, the regulators, and how to operate; and it is cheaper. But is it helping you find investment and achieve your longer-term goals?

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