Medicare Rx Conference Could Last Into Fall; AWP One Sticking Point

The House/Senate Medicare negotiations could last well into the fall, a staffer to Senate Majority Leader Bill Frist (R-Tenn.) predicted July 1

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Adaptive Clinical Trials Require ‘Clear And Compelling Justification’

 
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A draft international guideline on using adaptive trial designs says sponsors should provide a clear rationale for using such designs to address the potential ‘tension’ between the confirmatory nature of late-stage trials and the flexibility introduced by mid-trial adaptations.

What Pharma Needs To Know About Vietnam’s Drug Registration Reforms

 

Newly introduced rules for streamlining drug registration in Vietnam are said to present both opportunities and challenges for stakeholders.

European Industry Calls For Support As It Juggles Multiple Challenges

 
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At Medicines for Europe’s legal and annual conferences in Brussels last week, multiple key issues competed for attention, giving the generics and biosimilars industry plenty to think about at a critical time for EU pharma reform.