News & Analysis as of August 29, 2025

European Medicines Agency (EMA)

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Read guidance, analysis, and updates on the myriad issues arising from the global response to the COVID-19 pandemic. Updated hourly every day, the insights published here are written by leading lawyers and law firms helping to make sense of insurance, employment, tax, securities, M&A, risk management, and every other consideration touched by this crisis. Follow the channel for a daily email brief of the latest and best updates. less -

European Commission Approves Moderna’s Updated COVID-19 Vaccine

Goodwin on 8/19/2025

On July 30, 2025, Moderna announced that the European Commission (EC) granted marketing authorization for the updated formulation of Moderna’s COVID-19 vaccine Spikevax®. The updated vaccine targets the LP.8.1 variant of...more

Regulatory Considerations For Covid-19 Next Generation Vaccines

A&O Shearman on 3/15/2021

As next generation Covid-19 vaccine developers consider whether ethical and practical clinical efficacy trials can be conducted, they might consider whether vaccine efficacy can instead be inferred. We consider the...more

Coronavirus: The Hill and the Headlines, January 2021 # 8

Hogan Lovells on 1/14/2021

In Washington: The House voted 232-197 to impeach President Trump for a second time on a charge of inciting insurrection over the Jan. 6 siege on the U.S. Capitol that left five people, including a Capitol Police officer,...more

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

Hogan Lovells on 11/17/2020

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

COVID-19: Daily Report for Life Sciences and Health Care Companies (UPDATED)

Hogan Lovells on 6/9/2020

The Daily Report is a compilation of COVID-19 (coronavirus) news briefs from around the world to help life sciences and health care companies stay current in this challenging time....more

Spain’s AEMPS clarifies position on hydroxychloroquine, echoing statements of EMA and Lancet

Hogan Lovells on 6/6/2020

The Spanish Agency for Medicinal Products and Medical Devices (AEMPS) stated that it will not take, for the time being, any regulatory action to temporarily suspend or halt the recruitment of patients for clinical trials to...more

Europe Update – Life Sciences Products and COVID-19: From Clinical Trials to Regulatory Flexibility

King & Spalding on 4/22/2020

In March, most European Union (‘EU’) countries ordered some form of lockdown and adopted many national measures to address or prevent issues raised by COVID-19. The health crisis pushed national authorities to focus on their...more

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