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Pharmaceutical Industry › Regulatory Agencies › European Union

Rothwell, Figg, Ernst & Manbeck, P.C.

How the U.S. Compares to Europe on Biosimilar Approvals and Products In the Pipeline – Updated May 2, 2025

Rothwell, Figg, Ernst & Manbeck, P.C. on

FDA approves Omylco® (omalizumab), first biosimilar of Xolair®. After Q1, FDA and EMA on track for a record number of biosimilar authorizations in 2025....more

Goodwin

European Biosimilar Regulatory Updates

Goodwin on

STADA and Xbrane Announce Approval of Ranibizumab Biosimilar in UK - On January 16, 2023, STADA Arzneimittel AG (STADA) and Xbrane Biopharyma AB (Xbrane) announced that the UK’s Medicines and Healthcare product Regulatory...more

Goodwin

Emer Cooke takes office as first woman head of EMA

Goodwin on

Emer Cooke, with 30 years’ experience in international regulatory affairs, took up her position this morning as Executive Director of EMA with a renewable five-year mandate. Previously, Ms. Cooke worked for the pharmaceutical...more

Hogan Lovells

UK MHRA consults on no-deal Brexit legislation

Hogan Lovells on

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has initiated a consultation on the legislation and regulatory processes for medicines, medical devices and related clinical trials that would need to be...more

Womble Bond Dickinson

Higher than expected European Medicines Agency staff losses will impact its business continuity plan

Womble Bond Dickinson on

The EMA will be launching Phase 3 of its business continuity plan on October 1, 2018 at the latest, however, the detail of the plan will now be impacted by the EMA announced this week that it has realized that it will lose...more

Hogan Lovells

UK publishes paper on Brexit and medicines regulation

Hogan Lovells on

On the same day as the European Council voted to move the European Medicines Agency (EMA) from London to Amsterdam, the UK Parliament issued a briefing paper on Brexit and medicines regulation. ...more

Hogan Lovells

EMAmsterdam: Hogan Lovells welcomes its new neighbour

Hogan Lovells on

By Hein van den Bos, Ruth Franken and Silvia Gardini After months of discussion, a final vote has been cast on the European Medicines Agency (EMA)'s new home post-Brexit. And it's right around the corner from us, here in...more

Hogan Lovells

FDA to Rely on Drug Inspections Performed by Certain European Regulatory Authorities Beginning November 1, 2017

Hogan Lovells on

Earlier yesterday, FDA announced that it has determined that the regulatory authorities of Austria, Croatia, France, Italy, Malta, Spain, Sweden, and the United Kingdom are “capable of conducting inspections of...more

Hogan Lovells

A Difficult Decision for EMA

Hogan Lovells on

The bids to host the EMA are in! We have reviewed all of them and give you our personal impressions on what to expect. After the EMA has announced the development of a business continuity plan to deal with the workload...more

Hogan Lovells

Relocation of the EU Medicines Agency – Ireland Island of Saints and Scholars

Hogan Lovells on

The EMA is looking for a new home. In this blog post partner Elisabethann Wright argues the case for Ireland. For thousands of years Ireland has been known as the Island of Saints and Scholars. The country is also world...more

Hogan Lovells

Relocation of the EU Medicines Agency: Italy

Hogan Lovells on

The EU Medicines Agency (EMA), the most sought after EU regulator, is looking for a new home. 900 jobs will move from London to an EU Member State when Brexit is complete. In a series of blog posts, our European life science...more

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