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Life Sciences Biotechnology European Medicines Agency (EMA)

Goodwin

EMA Issues Positive CHMP Opinions for Fresenius Denosumab Biosimilars

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On May 27, 2025, Fresenius Kabi (“Fresenius”) announced that the EMA’s Committee for Medicinal Products for Human Use (“CHMP”) had issued positive opinions for Fresenius’s two denosumab biosimilar candidates....more

Hogan Lovells

EMA publishes list of COVID-19 treatments that have been the subject of the Agency’s guidance

Hogan Lovells on

On 30 October 2020, the European Medicines Agency (“EMA”) published a list containing all COVID-19 treatments and vaccines that have so far been the subject of scientific advice or informal guidance from EMA’s pandemic Task...more

Hogan Lovells

EU Clinical Trials Regulation to apply from December 2021

Hogan Lovells on

On 12 June 2020, the management board of the European Medicines Agency (EMA) announced December 2021 as the date of entry into application of the EU Clinical Trials Information System (CTIS). ...more

Hogan Lovells

European Medicines Agency’s clarification regarding re-testing exemption for imported advanced therapy medicinal products

Hogan Lovells on

On 21 August 2019, the European Medicines Agency (EMA) published questions and answers regarding imported advanced therapy medicinal products (ATMP). The document focuses on the possibility of batch controls exemption for...more

Wilson Sonsini Goodrich & Rosati

2018 Life Sciences Securities Litigation Roundup

2018 Filings - Companies in the life sciences industry, including biotechnology, medical devices, and pharmaceuticals, have long been favorite targets of securities class actions, and 2018 was no exception. According to a...more

Hogan Lovells

A broader definition of “unmet needs” has been proposed to support the development of anti-bacterial medicinal products

Hogan Lovells on

The concept paper - The EMA has published a “Concept paper on preparation of a revised guideline on the evaluation of medicinal products indicated for treatment of bacterial infections.”...more

Hogan Lovells

HMA-EMA’s work programme on availability of authorised medicines for human and veterinary use includes measures for Brexit

Hogan Lovells on

On 23 August 2018, the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA), the network of the National Competent Authorities in the European Economic Area (EEA), published the work programme of their...more

Hogan Lovells

UK Parliamentary Committee Publishes Life Sciences Brexit Negotiation Recommendations

Hogan Lovells on

The UK House of Commons Health and Social Care Committee has published the findings of its six-month long investigation into the impact of Brexit on medicines, medical devices and substances of human origin. ...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

The commission assessment – a decision-making aid for EMA's relocation?

Hogan Lovells on

Last week, a staff retention survey was published, according to which certain contestants in the race for hosting the EMA were less liked by the EMA staff. And now the decision-making progress is going forward....more

Hogan Lovells

EMA released reflexion paper clarifying information related to the selection of starting materials

Hogan Lovells on

The European Medicines Agency (“EMA”) has released a reflexion paper on the requirements for selection and justification of starting materials for the manufacture of chemical active substances. The reflexion paper provides...more

Hogan Lovells

Relocation of the European Medicines Agency – France shows EMA its smooth moves

Hogan Lovells on

With Brexit under way, the European Medicines Agency is looking for a new home. France revealed itself as a serious contender when it considered offering not just one hosting place for the Agency, but five! Up until recently,...more

Hogan Lovells

Relocation of the EU Medicines Agency – Spain

Hogan Lovells on

"Spain is waiting for the EMA. Barcelona is ready". With this conviction, and with the conviction that everything is ready, the Spanish Minister for Health addressed the European Commissioner for Health & Food Safety, Mr...more

Hogan Lovells

Relocation of the EU Medicines Agency – Germany

Hogan Lovells on

"EMA" and "gErMAny" – far more in common than mere letters - The European Medicines Agency (the "EMA"/"Agency") has reached celebrity-style status in the aftermath of the Brexit vote, and is being wooed by most European...more

Hogan Lovells

Relocation of the EU Medicines Agency - The Netherlands: Tulips & EMA, a Gouda combination

Hogan Lovells on

The EMA is looking for a new home. According to the Dutch Minister of Foreign Affairs and the Minister of Health, Welfare and Sports' formal bid, this home is where the heart of the Netherlands is. It might not have the food,...more

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