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World Health Organization European Union Pharmaceutical Industry

Sheppard Mullin Richter & Hampton LLP

Recent Healthcare-Related Artificial Intelligence Developments

AI is here to stay. The development and use of artificial intelligence (“AI”) is rapidly growing in the healthcare landscape with no signs of slowing down. From a governmental perspective, many federal agencies are embracing...more

MoFo Life Sciences

Vaccine Production And State Intervention In The U.S.

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During the COVID-19 pandemic, governments across the globe have become increasingly involved in the private sector. State-owned enterprises have long been common in Asia, but the pandemic has increased their prominence in...more

King & Spalding

EUROPE – The General Court Limits the Scope of “Satisfactory Methods” That Must Be Compared for Orphan Drug Designation

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On 23 September 2020, in a landmark case, Medac v Commission, the trial-level General Court (“GC”) of the European Union (“EU”) annulled the decision of the European Commission (“EU Commission”) that had withdrawn the orphan...more

Goodwin

Year in Review: Top 5 Foreign Market Developments in 2017

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Here are our picks for the top-five most significant foreign market developments in the world of biosimilars in 2017...more

Jones Day

EMA Green Lights New EudraVigilance System for Adverse Reactions, Pharmaceutical & Medical Device Update, Vol. IV, Issue III

Jones Day on

On May 22, 2017, the European Medicines Agency ("EMA") announced the full functionality of the new EudraVigilance system for the collection and monitoring of suspected adverse reactions with medicinal products that are...more

Goodwin

Year in Review: Top Five Foreign Market Developments of 2016

Goodwin on

Here are our picks for the top-five most significant foreign market developments in the world of biosimilars in 2016: Various guidance documents have been published this year further defining regulatory requirements for...more

Mintz - Health Care Viewpoints

FTC Urges FDA to Rethink Its Biosimilar Naming Proposal; Other Stakeholders Agree

The Federal Trade Commission (FTC) last week disputed the effectiveness and competitive impact of the Food and Drug Administration’s recently proposed biosimilar naming policy and argued that using different nonproprietary...more

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