Coronavirus Update: Setback With Hydroxychloroquine, Slowdown In UK ADR Reports, But Novel Drugs Begin Trials

 
• By Ian Schofield
  
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In addition to our daily in-depth coverage of key events relating to the coronavirus, we’re bringing you a periodic round-up of other pandemic developments. This edition covers events at the national, European and global level. 

Hydroxychloroquine
Hydroxychloroquine's side-effects are causing concern in COVID-19 studies • Source: Shutterstock

This latest Pink Sheet coronavirus update looks at the possible knock-on effects of the WHO’s suspension of its hydroxychloroquine trial, the UK’s decision to back the use of remdesivir in coronavirus patients (and to boost ADR reports), and a plea from the EU regulator to make sure any large-scale observational trials in COVID-19 are well designed and adequately powered.

Hydroxychloroquine is back in the news after the World Health Organization placed a temporary hold on the hydroxychloroquine arm of...

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EU Biosimilar Filings, Opinions And Approvals

 
• By Saba Afreen

<p>Executive Summary</p> <p>A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.</p>

EU Pharma Reform: What You Need to Know Now

 
• By Anabel Costa-Ferreira and Ian Schofield

As the reform of the EU pharmaceutical legislation progresses through the legislative process, the Pinks Sheet offers an infographic highlighting some of the key changes being proposed that will reshape the way drug companies run their business.

New EU Approvals

<p>Executive Summary<p> <p>The Pink Sheet's list of EU centralized approvals of new active substances has been updated to add six new products, incl/ding Ixchiq, Valneva's chikungunya virus vaccine</p>

More from Geography

Canada Cuts Red Tape With Single Ethics Review For Trials

A new research ethics review system for multi-site clinical trials in Canada is expected to help improve study start-up times, avoid unnecessary duplication and boost the country’s competitiveness on a global stage.

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• By Brian Bossetta

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Diversity Action Plans: What To Submit And When

 
• By Nielsen Hobbs

With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be implemented.