Orphan Drugs Need Easier, Speedier Approval, Not More Exclusivity, CEO Says

Advocates and drug developers continue to call for an Orphan Drug Act renovation – not to add more years of marketing exclusivity, but to consider allowing easier and cheaper development programs.

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Brazil To Upgrade Pricing Framework To Keep Up With Market Developments

 

Brazil plans to clarify its medicine pricing framework, for example by outlining the procedures for setting medicine prices and bring it up to date with recent developments in the sector.

England: HTA Sandbox Helping To Assess ‘Challenging’ Drugs And Indications

 

England’s health technology assessment institute explains how its sandbox environment is helping to test new evaluation methods for drugs or indications with which it does not have experience, such as metabolic dysfunction-associated steatohepatitis.

Unlocking Opportunities: How To Engage With The EMA On Animal Testing Alternatives

 

The European Medicines Agency, like its counterpart in the US, is increasingly focusing on the use of alternatives to animal testing.