This latest edition of the Pink Sheet’s coronavirus updates covers events including new studies of a gout drug to help stem the inflammatory cascade in coronavirus patients, an EU “solidarity pact” to help speed up R&D, and an expedited clinical trial review process in Ireland.
Coronavirus Update: Old Drugs, New Trials, And Brexit
In addition to our daily in-depth coverage of key events relating to the COVID-19 pandemic, we’re bringing you a periodic round-up of other developments. This edition covers events at the national, EU and global level.
More from Europe
• By
The European Medicines Agency has recommended five drugs for EU-wide approval , including Averoa’s Xoanacyl for concomitant hyperphosphatemia. Two companies have withdrawn their marketing authorization applications.
• By
Eli Lilly’ will request a re-examination after the European Medicines Agency declined to recommend its Alzheimer’s disease drug Kisunla for EU approval.
• By
The new global GCP guideline, ICH E6(R3), enables researchers and clinical trial administrators to tailor their documentation processes, but also opens the door for more scrutiny during GCP inspections.
• By
A German ordinance implementing the EU Health Technology Assessment Regulation offers little clarity on how far joint clinical assessment reports should be considered by national authorities.
More from Geography
• By
The European Medicines Agency has recommended five drugs for EU-wide approval , including Averoa’s Xoanacyl for concomitant hyperphosphatemia. Two companies have withdrawn their marketing authorization applications.
• By
Eli Lilly’ will request a re-examination after the European Medicines Agency declined to recommend its Alzheimer’s disease drug Kisunla for EU approval.
• By
Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.