News & Analysis as of

European Union › Research and Development › Pharmaceutical Industry

The European Union is an economic and political partnership comprised of 27 nations within the Eurozone. The EU was established in 1948 to promote stability and cooperation among member states in the aftermath of... more +
The European Union is an economic and political partnership comprised of 27 nations within the Eurozone. The EU was established in 1948 to promote stability and cooperation among member states in the aftermath of WWII. The EU maintains a common currency as well as several intranational institutions, including the European Parliament and the European Commission. less -
Goodwin

Alteogen’s Aflibercept Biosimilar Receives Positive CHMP Opinion

Goodwin on

​​​​​​​We previously reported that South Korean biopharmaceutical company Alteogen submitted its Marketing Authorization Application to the European Medicines Agency (“EMA”) for ALT-L9, what has since been named EYLUXVI. ...more

A&O Shearman

A new European strategy to foster life sciences innovation and market access

A&O Shearman on

On July 2, 2025, the European Commission released its communication “Choose Europe for life sciences. A strategy to position the EU as the world’s most attractive place for life sciences by 2030” (the Strategy). ...more

Morgan Lewis - As Prescribed

New Measures to Encourage Clinical Trials in the United Kingdom

Morgan Lewis - As Prescribed on

While the US Food and Drug Administration has been experiencing recent reorganization and cuts in personnel, the United Kingdom has its own upcoming policy changes making it easier and faster to initiate and maintain UK...more

Goodwin

Global Biosimilar Updates - Spring 2025

Goodwin on

Celltrion’s ustekinumab biosimilar, STEQEYMA®, has won its first bid within 2 months of its launch in January of 2025. Since launch, STEQEYMA® has secured contracts in four regions of Italy, including, Piemonte, Valle...more

TransPerfect Legal

GDPR Compliance: At the Intersection of AI and Life Sciences

TransPerfect Legal on

Late last month, the Association of Corporate Counsel (ACC) hosted a panel on artificial intelligence and how it is rapidly transforming the life sciences sector, allowing companies to leverage large datasets to accelerate...more

Skadden, Arps, Slate, Meagher & Flom LLP

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

Skadden, Arps, Slate, Meagher & Flom LLP on

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

Goodwin

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

Goodwin on

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

McDermott Will & Schulte

Transaction Trends in Life Sciences

McDermott Will & Schulte on

In November, we were delighted to once again host our annual European Health & Life Sciences Symposium in Paris. The event attracted a large number of healthcare professionals, investors and dealmakers to the Shangri-La Hotel...more

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in Q1 2024 and Beyond

Goodwin on

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

Skadden, Arps, Slate, Meagher & Flom LLP

Proposed EU Competitor Cooperation Guidelines Tougher on Information Sharing, but Scope Provided for Sustainability Agreements

Skadden, Arps, Slate, Meagher & Flom LLP on

The European Commission (Commission) is accepting public comment on its proposed revisions to European Union regulations and guidance on common competitor cooperation arrangements, which are due to expire on 31 December 2022....more

Morgan Lewis

COVID-19: The Return of the ‘Comfort Letter’

Morgan Lewis on

The European Commission published its first comfort letter in nearly 20 years on April 29, in an effort to foster cooperation among businesses during the coronavirus (COVID-19) pandemic. ...more

Hogan Lovells

Cooperation in the life sciences industry and EU competition law in the context of COVID-19

Hogan Lovells on

The life sciences industry is facing unprecedented demands due to COVID-19. From front line carers to researchers and scientists, significant efforts are being put towards caring for those suffering from COVID-19 and...more

Hogan Lovells

Life Sciences and Health Care Horizons - 2020

Hogan Lovells on

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

Hogan Lovells

The Court of Justice of the European Union provides clarifications on the assessment under competition law of pay-for-delay deals...

Hogan Lovells on

On 30 January 2020, the Court of Justice of the European Union (CJEU) issued its decision on a request for preliminary ruling submitted by the UK Competition Appeal Tribunal (CAT) in a case concerning the long-standing...more

Hogan Lovells

The importance of conscientious health data collection in European clinical trials

Hogan Lovells on

Clinical trials have become increasingly important for pharmaceutical companies and medical device manufacturers, which are focused on collecting as much data as possible on products and devices and their adverse effects. All...more

Jones Day

The EU Pharma Incentives Review—Two Studies and a Legislative Proposal Released

Jones Day on

The Situation: On May 28 and 29, 2018, the European Commission ("Commission") published two studies aimed at examining the economic and legal impacts of the European Union's regime on Supplementary Protection Certificates...more

Hogan Lovells

EMA provides essential considerations to be taken into account for successful qualification of novel methodologies

Hogan Lovells on

The European Medicines Agency (“EMA”) has published a checklist of the essential considerations to be addressed for successful qualification of novel methodologies....more

Goodwin

Biocon Announces Insulin Glargine Biosimilar Has Met Key Phase III Milestones, Is On Track for US and EU Regulatory Filings

Goodwin on

Biocon recently announced that its global phase III clinical development program for biosimilar insulin glargine “has crossed key interim milestones,” putting Biocon “on track for regulatory filings in US and EU in FY 17.” ...more

18 Results
 / 
View per page
Page: of 1

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
Sign up Log in
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide