European Medicines Agency

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European Medicines Agency Initiates Rolling Review of AZD1222 While FDA Puts Trial on Hold for a Different Review

The European Medicines Agency (EMA) human medicines committee (CHMP) reports publicly the first ‘rolling review’ of a COVID-19 vaccine starting with AstraZeneca’s AZD1222 or the “Oxford” vaccine. This committee is investigating the first batch of data on the vaccine...

Top Law Firm’s Italian Clinical Trial Specialists Discuss Challenges & New Opportunities Conducting Clinical Trials in Italy During COVID-19

The EU Commission, the European Medicines Agency (EMA), and the Heads of Medicines Agency (HMA) published new guidelines on April 28, 2020 on the management of clinical trials during the COVID-19 pandemic. Serving as a set of harmonized recommendations across the EU,...

Baby Pia Denied Compassionate Use: Something ‘Ain’t’ Right in Basel

Novartis just can’t keep out of bad news. They have denied a request from the Belgian federal government to make the most expensive drug in the world (Zolgensma at $2 million) available to a Belgian toddler named Pia who suffers from spinal muscular atrophy, despite...

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