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?
The US FDA’s decision to reverse a refuse-to-file action on Alkermes PLC’s investigational antidepressant ALKS 5461 is very good news for Alkermes – but it is hard to argue that either the agency or the sponsor comes out of the regulatory kerfuffle looking particularly good.
The decision to refuse-to-file an application is typically based on missing data or facial deficiencies within the submission. In the case of ALKS 5461, there appears to have been a...
Research would include initiatives on reproducing industry-sponsored studies, postmarket surveillance, and studies of long-term neurodevelopmental and metabolic outcomes for commonly prescribed pediatric drugs.
The budget authority total, which is significantly higher than the amount floated in an April OMB draft document, suggests there may have been successful lobbying to increase FDA funding.
In this first in a series of articles looking at the potential impact of the MFN drug pricing policy on European pharmaceutical markets, EUCOPE’s Alexander Natz tells the Pink Sheet why the US policy underscores the importance of confidential net pricing.
