Five Compounds To Be Tested In UK’s TACTIC Coronavirus Study
Platform Trial Involves Novel Drugs And Combinations
The UK government has awarded “urgent public health status” to a clinical trial program that will test one investigational product and four existing drugs in an effort to quickly find new treatments for patients hospitalized with serious COVID-19 infection.
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Efforts to overhaul the EU pharmaceutical legislation have been given added impetus after the European Parliament called for action to boost innovation and medicines access, shore up manufacturing and supply chains, and examine the link between R&D spending and drug prices.
The EMA is going all out to maximize coverage of the EU population with both vaccines and treatments for COVID-19.
Drug sponsors seeking centralized EU marketing authorizations now have the opportunity to have simpler pre-submission “interactions” with the European Medicines Agency six months before the submission to help avoid complications down the line. Full meetings may still be appropriate for complex issues such as requests for accelerated assessment or conditional approval.