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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 […]
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 […]
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 […]
Complex Drug Products and their Generic Counterparts
At the New York Academy of Sciences’ symposium on Equivalence of Complex Drug Products: Scientific and Regulatory Challenges, regulatory officials described how agencies approach evaluating complex generics for marketing approval. In 2015, almost 90% of prescriptions in the United States were for generics, according to the Generic Pharmaceutical Association. However, there are certain complex drug […]