Breaking Up With Breakthrough: Trevena And Tonix Lose Designation, But Continue With Pivotal Plans
US FDA rescinds breakthrough designations for Tonix’ PTSD therapy Tonyma and Trevena’s novel pain drug Olinvo after clinical trial disappointments – and after identifying other regulatory pathways to market.
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The decision to maintain or revoke breakthrough therapy status when trial results do not appear to support the original designation will depend on the facts specific to a development program, the US FDA says in new draft guidance. Since 2012, the agency has granted 475 breakthrough therapy designation requests and rescinded 35 designations.
Sixteen applications are in line for US FDA decisions in August. Ten are novel agents.
Keeping Track: Good News For Deciphera, BMS And Clovis; Bad News For bluebird/BMS, Blueprint And Tonix
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.