Brexit: leveraging the mutual recognition agreement to mitigate risk with commercial drug product release testing

The Brexit1 deadline has been extended once again – now to January 31, 2020 – and a withdrawal deal seems likely given the result of the December 12 general election. However, drug manufacturers and contract test laboratories should be proactive in understanding the potential regulatory considerations relating to commercial drug product …

What the new EU endocrine disruptor assessment means for renewal of your active ingredients

Introduction The new EU requirements for endocrine disruptor identification will impact any active ingredient (AI) renewals with expected decisions from November 2018 onwards. Learn more about these requirements and key strategies to meet them, below[CS1] [CS2]. The European Commission has adopted new criteria for identifying endocrine disruptors (EDs) – these criteria …

5 different kinds of cytokine release assays: weathering the storm | CRA Post II

In our previous post, we outlined the dangers of Cytokine Release Syndrome (CRS) and the importance of preclinical Cytokine Release Assays (CRAs) when developing monoclonal antibodies (mAbs) that interact with the patient’s immune system. In this second post, we describe the different kinds of assays in use and how these …

In vitro cytokine release assays: is there calm after the storm? | CRA Post I

What is a cytokine storm?  Cytokine Release Syndrome (CRS), otherwise known as cytokine storm, is a systemic inflammatory response caused by complications due to disease, infection or an adverse effect of biologic therapy. The clinical symptoms of a cytokine storm are massive release of a potent cocktail of pro-inflammatory cytokines …

Photo of a bee

What you need to know about neonicotinoids and the EU

Introduction Neonicotinoids were developed to find safer, more effective alternatives to chlorinated hydrocarbons, organophosphates, carbamates, and pyrethroids, so, ironically, some neonicotinoids are now banned in the EU because of their toxicity to bees and other pollinators, as well as to a wider group of species. The agricultural and environmental consequences …

RA Biosimilar Recruitment

RA biosimilar studies recruitment strategy? How to succeed despite increasing volume of RA biosimilar development programs

Introduction Although a range of regulatory definitions exist, a biosimilar drug is generally defined as a biological compound that is highly similar to the reference drug, with no clinically meaningful differences in safety, purity and potency.1,2 In addition, biosimilars can be characterized as reducing healthcare costs while maintaining clinical efficacy …

Understanding Annexes VII-X

Avoiding obstacles with REACH Annexes VII-X Posted by Dr. David Howes, Expert Consultant in Chemical Legislation and Chemistry, Covance In the EU, the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulations address the manufacturing and import of chemicals to ensure they are safe for human health and the environment. …

Step inside Mechelen: a day in the life of a regional study coordinator’s project management role

Elien is a Senior Regional Study Coordinator (RSC), which is an associate project manager role, housed in our growing Mechelen, Belgium office for Covance Central Laboratory Services (CLS). She shared a glimpse inside a typical day as a Regional Study Coordinator, a role that manages local laboratory operations within our …

Covance Shanghai strengthens safety pharmacology capabilities for in-house IND packages in Asia

Covance Shanghai is pleased to announce an expansion of its general toxicology capabilities to include safety pharmacology studies, allowing our Asia-Pacific clients to more easily complete their IND requirements for CFDA regulations. What are the new safety pharmacology offerings? The general tox team in Shanghai is now capable of running …