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Biotechnology European Union

Bergeson & Campbell, P.C.

EC Publishes Summary Report on Public Consultation for EU Bioeconomy Strategy

The European Commission (EC) has published a report summarizing comments received during the public consultation for the initiative “Towards a circular, regenerative and competitive bioeconomy.” As reported in our April 1,...more

Goodwin

European Biosimilar Updates - Alvotech/Advanz’s MYNZEPLI Approval and Bio-Thera/STADA Tocilizumab Alliance

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On August 21, 2025, Alvotech and Advanz Pharma Holdco Limited (“Advanz”) announced that MYNZEPLI®, a biosimilar of Regeneron’s EYLEA® (aflibercept), was approved by the European Commission. ...more

Gardner Law

[Hybrid Event] Navigating What’s Next: AI, Compliance, and Regulation in Life Sciences - November 6th, Mountain View, CA

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Gardner Law is excited to announce Navigating What's Next: AI, Compliance, and Regulation in Life Sciences, being held live at the Shashi Hotel in the heart of Silicon Valley on November 6, starting at 9:00 a.m. Pacific Time....more

Goodwin

Alteogen’s Aflibercept Biosimilar Receives Positive CHMP Opinion

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​​​​​​​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

Bergeson & Campbell, P.C.

EC Begins Public Consultation on Biotech Act

The European Commission (EC) began a public consultation on August 4, 2025, on the European Biotech Act in the form of an online questionnaire. According to the EC, the aim is to gather evidence and views from stakeholders...more

Bergeson & Campbell, P.C.

Cefic Publishes Position Paper on EU Bioeconomy Strategy, Calls for Industrial Bioeconomy Strategy

On July 1, 2025, the European Chemical Industry Council (Cefic) announced a new position paper and five-point action plan that will “help deliver a [European Union (EU)] Bioeconomy Strategy that supports the scale-up of...more

Goodwin

Biocon Regulatory Approval Updates in the U.S. and Europe: Insulin Aspart and Denosumab

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On July 15, 2025, Biocon Biologics, a fully integrated global biosimilars company and a subsidiary of Biocon Ltd., announced that the FDA has approved KIRSTY (insulin aspart-xjhz injection), 100 units/mL, as the first and...more

A&O Shearman

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

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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

Bergeson & Campbell, P.C.

Call for Evidence for Impact Assessment of the European Biotech Act Will Close June 11, 2025

The European Commission (EC) began a call for evidence on May 14, 2025, for an impact assessment of the European Biotech Act. The EC states that the overall objective is to improve the size and competitiveness of the...more

McDermott Will & Schulte

Transaction and Financing Trends in Life Sciences - European Health & Life Sciences Symposium 2025

In April, McDermott was pleased to once again host our annual European Health & Life Sciences Symposium in Paris. Welcoming a crowd of more than 300 innovators, investors, business leaders and advisers from across the...more

American Conference Institute (ACI)

[Event] European Summit For Women Leaders in Life Sciences Law - March 11th - 12th, Brussels, Belgium

Excitement is building as C5’s inaugural European Summit For Women Leaders in Life Sciences Law gets closer. Make plans to join women at the forefront of life sciences law as they address legal, regulatory, and policy...more

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

CRISPR and Agriculture

Modern gene-editing technology, such as CRISPR/Cas technology, represents a ground-breaking advancement that has transformed our genetic engineering capabilities and has enormous potential for revolutionising medicine, food...more

Bergeson & Campbell, P.C.

EC Launches Biotech and Biomanufacturing Hub to Support Innovative Companies

The European Commission (EC) announced on January 29, 2025, that it launched a Biotech and Biomanufacturing Hub to support companies — particularly start-ups and small and medium-sized enterprises (SME) — in bringing...more

Orrick, Herrington & Sutcliffe LLP

The EU AI Act: Key Takeaways for Life Sciences and Digital Health Companies

This update is part of our EU AI Act Essentials Series. The European AI Act is a landmark piece of legislation that establishes the first major comprehensive framework for regulating the use of artificial intelligence,...more

Bergeson & Campbell, P.C.

EC Publishes Communication on Biotechnology and Biomanufacturing, Announces Targeted Actions

The European Commission (EC) announced on March 20, 2024, that it has proposed a series of targeted actions to boost biotechnology and biomanufacturing in the European Union (EU). The EC states that its March 20, 2024,...more

American Conference Institute (ACI)

[Event] Pharma & Biotech Patent Litigation Conference in Europe - May 29th - 30th, Amsterdam, Netherlands

Hosted by C5 Group, the 17th Annual Forum on Pharma & Biotech Patent Litigation in Europe returns for another exciting year with curated programming that will provide up-to-the-minute information and strategic insights on...more

Hogan Lovells

New Commission Action Plan to boost biotechnology and biomanufacturing in the EU

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Today, 20 March 2024, the European Commission issued an important Communication aimed at boosting biotechnology and biomanufacturing in the EU. These sectors are identified as key strategic areas with ever-increasing growth...more

McDermott Will & Schulte

Transaction Trends in Life Sciences

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

European Biologics Regulatory Updates

Goodwin on

Bayer’s aflibercept 8 mg recommended for approval in Europe: On November 10, 2023, Bayer announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive...more

Jones Day

European Commission Signals Increased Scrutiny in Semiconductors, AI, Quantum Technologies, and Biotechnologies

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On October 3, 2023, the European Commission ("Commission") unveiled a list of 10 technology areas qualified as "critical" to the European Union's ("EU") economic security, out of which four (Semiconductors, AI, Quantum...more

Gardner Law

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

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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

White & Case LLP

Transatlantic M&A bull run set for comeback

White & Case LLP on

Encouraged by the relative strength of the dollar and improving financing conditions, US bidders are snapping up European assets - Transatlantic M&A was enjoying record-high activity before the war in Ukraine sparked...more

American Conference Institute (ACI)

[Event] 21st Annual Life Sciences IP Summit - September 27th - 28th, Munich, Germany

Hosted by C5 Group, the 21st Annual Life Sciences IP Summit returns for another exciting year with curated programming with speakers from the pharma, biotech and medical device industries that will provide practical insights...more

Bergeson & Campbell, P.C.

EuropaBio Offers Recommendations on Biomanufacturing

On June 30, 2023, EuropaBio announced that it “set[] in stone the first European recommendations on biomanufacturing with the publication of its Biomanufacturing Policy Summit 2023 report.” On March 15, 2023, EuropaBio hosted...more

MoFo Life Sciences

The EU’S New Proposal For Plants Developed Using New Genomic Techniques: How Does It Compare To U.S. Regulation?

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After much anticipation, the EU Commission’s proposal for a regulation on plants developed using New Genomic Techniques (NGTs) is now under consideration. For an overview of the EU proposal, please see MoFo’s recent post....more

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