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Sourcing for Clinical Trials and Biosimilar Development

April 2017

Clinical trial supply is, to state the obvious, an expensive and multifaceted activity which continues to get more complex. Over the past 5 years, factors have extended this trend; for example: Changes in and development of legislation – New EU Clinical Trial regulations (No 536/2014), the Falsified Medicines Directive, US FDA Drug Supply Chain Security […]

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Gut Microbiome Trial Results “Promising” for ASD Treatment

March 2017

The recently published results of a clinical trial suggest that the gut microbiome might be the key to developing a new, potential treatment for autism spectrum disorder (ASD). The gut microbiome is a collection of microorganisms that live inside the human body. The microbiome is crucial when it comes to immunity and health, as it […]

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Differences in Clinical Trials for Biosimilars

January 2017

Researchers from the University of Massachusetts and Newcastle University have argued that clinical trial design for biosimilars needs to be standardized after highlighting differences in the safety evaluations and findings between clinical trials for these drugs. The researchers identified that different designs have been employed in some phase III clinical trials when comparing biosimilar TNF […]

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Clinical Trials Undertaken Of New Treatment Option For Rare Form Of Epilepsy

November 2016

A neuroactive steroid drug known as ganaxolone has been heralded as a new treatment option for a rare form of Epilepsy with positive clinical results so far. The rare form of epilepsy known as PCDH19, a paediatric orphan indication of epilepsy, only affects a small number of people. With around 30,000 cases of the illness […]

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