Alkermes Refuse-To-File Reversal: Is It Really Good News For Anyone?
US FDA’s decision to 'un-refuse' ALKS 5461 was made within same review office that was caught up in the Sarepta controversy – albeit in a different division. What does the RTF reversal mean for Alkermes and for the agency?
You may also be interested in...
Refusal Reversal: Alkermes Review Back On Track, But Could Still Be Bumpy
US FDA accepts Alkermes' NDA for depression drug after issuing refuse-to-file letter just two weeks ago; unusual move falls outside agency's guidance on RTFs because no changes were made to submission and it wasn't filed over protest.
PTC’s Ataluren and Accelerated Approval: Is Eteplirsen A Precedent After All?
US FDA appears willing to consider accelerated approval for PTC's Duchenne Muscular Dystrophy therapy ataluren if company is able to provide compelling evidence of increased levels of dystrophin in boys with nonsense-mutation DMD. That is quite a reversal from the agency’s view heading into PTC’s appeal.