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How Will Reforms Change the Landscape of China’s Clinical Trials?
China’s central government have introduced reforms in response to an increasingly challenging regulatory environment. These are likely to benefit medicine access as well as drug development, affecting those looking into China’s pharmaceutical market, which is the second largest in the world. In a long-awaited response to feedback from the local and international pharmaceutical industry, the […]
Best Practices for Successful Clinical Supply
The demands of clinical trial supply are constantly evolving, with the industry moving towards ever-more-elaborate studies and adaptive clinical trial designs. The progressive developments created by such factors can cause challenges for the clinical supply chain; so, when it comes to managing your global clinical supplies, it’s vital to choose a partner who sticks to […]
How Will Brexit Affect Clinical Trials?
Now that the UK has triggered Article 50, an important topic on many minds is how Britain’s exit from the European Union will affect clinical trials. Could Brexit benefit clinical trials? It is believed by some that the EU clinical trials directive has slowed the pace of research Britain has performed over the years and […]
Your Clinical Supply Chain – 4 Small Things That Can Have a Huge Impact
Small changes can have a big impact on the overall success of a clinical trial, having a significant effect on the clinical supply chain and even putting it at risk. Here are 4 factors that can have a knock-on effect on your clinical supply chain. Delays in Manufacture, Procurement and/or Packaging It can be frustrating […]
FDA Approval of Renflexis, a Biosimilar to Remicade
As of the 24th April 2017, the US Food and Drug Administration has approved Samsung Bioepis’ biosimilar version of Remicade (infliximab). The Biologics License Application (BLA) for the infliximab biosimilar candidate, Renflexis (SB2), was submitted to the FDA in May 2016. Infliximab is a chimeric monoclonal antibody administered intravenously, that is used for treating several […]