News & Analysis as of October 31, 2024

Pharmaceutical Industry

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The UK Cyber Security and Resilience Bill

Faegre Drinker Biddle & Reath LLP on 10/18/2024

The UK government has recently announced that it plans to introduce a Cyber Security and Resilience Bill (Bill). The Bill seeks to update the 2018 Network and Information Security Regulations, which implemented the European...more

Reduction of EU regulatory data protection, but not as short as the European Commission proposed - European Parliament’s position...

Hogan Lovells on 4/15/2024

On 10 April 2024 the European Parliament adopted its position on the draft text on the revision of the European Union’s (EU) general pharmaceutical legislation, also referred to as the (proposed) “EU Pharmaceutical Law...more

EU and Germany Lay Groundwork for the Use of Medical Data for Research and AI Training

Skadden, Arps, Slate, Meagher & Flom LLP on 4/4/2024

Both the EU and Germany are taking significant steps to accelerate digitalization in the health sector and facilitate the exchange and use of health data for research and innovation purposes. They aim to improve...more

A Look Ahead in Life Sciences: What We Are Tracking in Q2 2024 and Beyond

Goodwin on 4/1/2024

As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more

Decoded - Technology Law Insights, V 5, Issue 2, March 2024

Spilman Thomas & Battle, PLLC on 3/8/2024

HHS Cybersecurity Performance Goals and the Healthcare Industry - The healthcare industry is a major target for cyberattacks because of all of the personal information collected from patients. Recognizing that the healthcare...more

EU Emergency Response Update – Key Policy & Regulatory Developments No. 110

Jones Day on 1/15/2024

This regular alert covers key regulatory developments related to EU emergency responses, including in particular to Russia’s war of aggression against Ukraine, COVID-19, and cyber threats. It does not purport to provide an...more

[Hybrid Event] MASTERING TOMORROW'S HEALTHCARE TECH: A CUTTING-EDGE APPROACH TO REGULATORY, COMPLIANCE, AND PRIVACY DEMANDS -...

Gardner Law on 10/5/2023

FDA law firm Gardner Law and EU-based Fieldfisher discuss regulatory, compliance, and privacy matters relevant to high-tech healthcare products. - - Harnessing AI and Connected Devices in Medical Innovation in an...more

COVID-19 Key EU Developments, Policy & Regulatory Update No. 98

Jones Day on 3/22/2023

This regular update (no. 98 | 1 March 2023) covers key regulatory EU developments related to the evolving COVID-19 situation (Antitrust & State Aid; Trade/Export Controls; Medicines, Medical Devices and Personal Protective...more

COVID-19 Key EU Developments, Policy & Regulatory Update No. 95

Jones Day on 1/31/2023

This regular update (no. 95 | 9 January 2023) covers key regulatory EU developments related to the evolving COVID-19 situation (Antitrust & State Aid; Trade/Export Controls; Medicines, Medical Devices and Personal Protective...more

COVID-19 Key EU Developments, Policy & Regulatory Update No. 91

Jones Day on 11/22/2022

This regular alert covers key regulatory EU developments related to the COVID-19 situation. It does not purport to provide an exhaustive overview of developments and contains no analysis or opinion....more

COVID-19 Key EU Developments, Policy & Regulatory Update No. 86

Jones Day on 9/26/2022

Covid-19 Key EU Developments, Policy & Regulatory Update No. 85

Jones Day on 7/5/2022

COMPETITION & STATE AID - State Aid - European Commission approves new and amended Member State measures to support the economy - Since the onset of the coronavirus outbreak, the Commission has adopted a significant number...more

COVID-19 Key EU Developments, Policy & Regulatory Update No. 80

Jones Day on 4/28/2022

COMPETITION & STATE AID - State Aid - European Commission adopts Temporary Crisis Framework to support economy in context of Russia's invasion of Ukraine - On 23 March 2022, the Commission adopted a Communication on a...more

Covid-19 Key EU Developments, Policy & Regulatory Update No. 78

Jones Day on 3/24/2022

COMPETITION & STATE AID - State Aid - European Commission publishes first Report on implementation of Recovery and Resilience Facility - On 1 March 2022, the Commission published its first Report to the European...more

COVID-19 Key EU Developments, Policy & Regulatory Update No. 73

Jones Day on 2/4/2022

COMPETITION & STATE AID - Competition - Commission publishes Competition Policy – 2021 at a glance. On 22 December 2021, the European Commission published its Competition Policy – 2021 at a glance. ...more

COVID-19 Key EU Developments, Policy & Regulatory Update No.72

Jones Day on 1/20/2022

COMPETITION & STATE AID - Competition- European Commission expresses views on IAG’s (aborted) intended acquisition of Air Europa, including in light of impact of COVID-19 restrictions - On 16 December 2021, the...more

COVID-19 Key EU Developments, Policy & Regulatory Update No. 71

Jones Day on 1/6/2022

COMPETITION & STATE AID - Competition - Executive Vice President and Competition Commissioner Margrethe Vestager speaks at U.S. Chamber of Commerce's Transatlantic Business Works Summit. ...more

COVID-19 KEY EU Developments, Policy & Regulatory Update No. 70

Jones Day on 12/15/2021

COMPETITION & STATE AID - State Aid - European Commission adopts revised Guidelines on State aid to promote risk finance investments- On 6 December 2021, the Commission published its Communication on Guidelines on...more

COVID-19 Key EU Developments, Policy & Regulatory Update No.69

Jones Day on 12/9/2021

COMPETITION & STATE AID - State Aid - European Commission publishes revised Communication on State aid rules for Important Projects of Common European Interest (IPCEI). On 25 November 2021, the Commission published a...more

COVID-19 Key EU Developments, Policy & Regulatory Update No. 68

Jones Day on 12/3/2021

COMPETION & STATE AID - European Commission adopts Communication on a Competition Policy Fit for New Challenges - On 18 November 2021, the European Commission adopted a Communication on a Competition Policy Fit for New...more

COVID-19 Key EU Developments, Policy & Regulatory update No.67

Jones Day on 12/3/2021

COMPETITION & STATE AID - European Commission comments on transatlantic relations in post-pandemic world, including building resilient supply chains - On 12 November 2021, Executive Vice-President and Competition...more

U.S. Medical Device Manufacturers Should Take Note of New European Medical Device Regulations

Proskauer - Life Sciences on 10/1/2021

The European Union has been a leader in recent years when it comes to regulatory reform intended to protect individuals’ privacy, safety, and health. As Europe leads the way, regulators in the United States often follow suit...more

International News: COVID-19 Global Pandemic - May 2020

McDermott Will & Emery on 5/27/2020

The Legal Impact in Europe on Pharmaceutical and Medical Device Companies - The current crisis mode has triggered legal and commercial issues that affect the pharmaceutical and medical device industry across Europe. ...more

Life Sciences and Health Care Horizons - 2020

Hogan Lovells on 2/26/2020

We are pleased to provide you with the third annual installment of our Life Sciences and Health Care Horizons guide. For each of these guides, we have asked our industry thought leaders throughout the world to write about...more

The EU Medical Device Regulation: What’s Next?

McDermott Will & Emery on 2/3/2020

The EU Medical Device Regulation goes into application on 26 May 2020, with the In Vitro Diagnostic Medical Device Regulation set to follow on 26 May 2022. These new Regulations bring sweeping changes to the market clearance...more

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