News & Analysis as of

Coronavirus/COVID-19 European Commission Life Sciences

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... more +
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 -
Goodwin

European Commission Approves Moderna’s Updated COVID-19 Vaccine

Goodwin on

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

Kilpatrick

Looking Forward: EU Medical Devices Regulation

Kilpatrick on

At the end of each year, we have a habit of looking back at lessons learned, the ups, the downs, the works. And like in 2020 and 2021, the COVID-19 pandemic and related shortage of medical devices take center stage in our...more

MoFo Life Sciences

EU: IN VITRO Diagnostic Regulation Entered Into Force (Part 1 OF 3)

MoFo Life Sciences on

In vitro diagnostic medical devices (IVDs), hence devices used for medical tests on samples such as blood or tissue that have been taken from the human body, have become the center of attention in the public eye during the...more

Morgan Lewis

EU Imposes Authorization Requirements for COVID-19 Vaccine Exports

Morgan Lewis on

In response to delayed EU shipments of certain COVID-19 vaccines to the European Union, the European Commission (Commission) passed on 29 January 2021 Regulation 2021/111 (Export Authorization Regulation) which is in force...more

Hogan Lovells

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

Hogan Lovells on

In Tuesday's Report: European Commission proposes far-reaching pharmaceutical strategic plan, Biden names health care nominees, and warnings over Christmas COVID-19 spread....more

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

Breaking Down Moderna’s COVID-19 Patent Pledge: Why Did They Do It?

Last month, Moderna Therapeutics, one of the global leaders in the race to produce a COVID-19 vaccine, made the following statement regarding enforcement of its patents: We feel a special obligation under the current...more

King & Spalding

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

King & Spalding on

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

Hogan Lovells

An update on cooperation in the life sciences industry: the European Commission’s framework for sending “comfort letters” on...

Hogan Lovells on

The European Commission has published a Temporary Framework Communication to provide guidance to companies that are cooperating to ensure the supply and distribution of essential products – including medicines and medical...more

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