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- EMA leaders say single pivotal trial should not be default, decision must match evidence neededEMA chief Emer Cooke and other officials weighed in on the ongoing debate about the number of pivotal trials required for drug approval. They argued that requiring a single pivotal trial as a rigi…
- Sarepta Therapeutics agrees to pay $39 million to settle gene therapy dispute with RegenxbioSarepta Therapeutics has agreed to resolve a dispute with Regenxbio by paying $39 million. The payment settles claims related to gene therapy technology that both companies have been developing.…