The US FDA has given the go-ahead for marketing of ViiV healthcare’s novel HIV drug just as the EMA removes the accelerated assessment status from its application there.

The coronavirus pandemic could be a turning point for master protocol and platform trial designs, but clear guidance and coordination are still needed.

As remdesivir’s change in primary endpoint illustrates, there are many ways to measure potential treatments. A Pink Sheet analysis of 50 Phase III clinical trial protocols found numerous different approaches. Adaptive trials seems critical for speed, but a survival endpoint seems essential for durability.

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.