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Latest From DBV Technologies
Public Company Edition: The stock market has been unkind to biotech firms but investors rewarded some drug developers for clinical trial successes, including Scholar Rock and Day One, which raised $205m and $172.5m, respectively. However, some SPAC deals and an IPO never got off the ground.
Several new drugs are now on track for an EU marketing authorization after getting the EMA’s thumbs up this week.
Following regulatory setbacks in the US and also now in the EU, DBV Technologies is to conduct a new pivotal trial of a modified version of its peanut allergy patch to support its efforts to win marketing approval.
When Breakthrough Falls Short: US FDA Complete Response Letters Rising Among BTD Applications For Approval
More than half of the complete response letters issued for applications holding breakthrough status have been issued since 2020, reflecting difficult – and often rancorous – efficacy debates.
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