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European Commission European Union Orphan Drugs

Goodwin

The European Parliament Adopts Position on the European Commission’s Proposal for the First Major Overhaul of the EU Medicines...

Goodwin on

In April 2023, we published an alert in relation to two European Commission legislative proposals: new Regulation 2023/0131 and new Directive 2023/0132, to replace the current EU regulatory framework for all medicines...more

Goodwin

The European Commission Proposes First Major Overhaul of the EU Medicines Regulatory Framework in 20 Years: Orphan Medicines

Goodwin on

We recently published an alert in relation to the European Commission’s legislative proposals to replace the current EU regulatory framework for all medicines (including those for rare diseases and for children). One of the...more

A&O Shearman

EU Court says off-label treatments must not be considered when assessing the significant benefit criterion in orphan drugs

A&O Shearman on

On 23 September 2020, the General Court of the European Union (GC) annulled a decision of the European Commission (Commission) that had withdrawn the orphan drug status of Trecondi (Treosulfan)....more

King & Spalding

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

King & Spalding on

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Court (“GC”) of the European Union (“EU”) annulled the decision of the European Commission (“EU Commission”) that had withdrawn the orphan...more

King & Spalding

EUROPE – Are Revisions of the Orphan Drug Regulation and Adoption of a Regulation on “Unmet Medical Needs” on the Horizon

King & Spalding on

The European Commission (Commission) has released a Staff Working Document concerning its joint evaluation of the Orphan Regulation and the Paediatric Regulation (collectively, the Regulations) (Joint Evaluation) and an...more

Morgan Lewis

European Life Sciences Review: Issue 1

Morgan Lewis on

Welcome to the first issue of our EU Life Sciences Review . It is produced by our life sciences lawyers in London, Brussels, Frankfurt, Moscow, and Paris and covers some of the most critical developments in the pharmaceutical...more

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