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When Can You Ban Parallel Trade?

 
• By Ian Schofield

European commissioner's statements supporting countries' right to limit drug exports appears counter to EC actions against some who do.

Taking steps to prevent medicines being parallel exported from one European Union country to another is always fraught with uncertainty, despite a succession of rulings on the matter by the Court of Justice of the EU. And a recent statement by Health Commissioner Vytenis Andriukaitis that appears to conflict with action being taken by the commission's internal market directorate has done little to clarify the situation.

Andriukaitis, a Lithuanian physician and politician who has held the European Commission health and food safety portfolio since late 2014,...

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• By Francesca Bruce

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EU Tests Unified Pathway For Combined Drug/IVD Studies

 
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Kisunla Back In The Spotlight As EMA Reconsiders Alzheimer’s Drug Rejection

 
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It appears that the European Medicines Agency is making progress on its re-examination of Eli Lilly’s Alzheimer’s disease drug Kisunla, following an initial rejection in March based on safety concerns.

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Health Canada’s proposal to no longer require biosimilar manufacturers to prove the safety and efficacy of their product through Phase III clinical trials marks a pivotal change in Canada’s regulatory approach.

Alzheimer’s Drug Leqembi May Be On Course To India, Kisunla In The Wings

 
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