News & Analysis as of

Biotechnology European Union

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 & Emery

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

AEON Law

EU Study Shows Startups with IP 1000% More Likely to Be Funded

AEON Law on

The European Patent Office (EPO) and the European Union Intellectual Property Office (EUIPO) have released a 61-page study showing that EU startups that secure intellectual property (IP) rights protection are 10.2 times more...more

Jones Day

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

Jones Day on

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 -...

Gardner Law on

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?

MoFo Life Sciences on

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

White & Case LLP

European biotech enjoys a burst of dealmaking activity

White & Case LLP on

European biotech just enjoyed its most abundant quarter in nearly two years in a tentative sign of a renaissance in the sector. There were 46 deals in Q1 2023, the second biggest year for deals in the region on Mergermarket...more

Hogan Lovells

French decree regarding the “direct access”: a half-hearted step forward for pharmaceutical innovations

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Publication of the French decree regarding the experimentation of the "direct access" to pharmaceutical products with anticipated reimbursement: a half-hearted step forward for pharmaceutical innovations....more

Hogan Lovells

Décret relatif à l’accès direct : une avancée en demi-teinte pour les innovations pharmaceutiques

Hogan Lovells on

Publication du décret relatif à l’expérimentation du dispositif d’accès direct des médicaments à un financement anticipé : une avancée en demi-teinte s’agissant de l’accès au marché des innovations pharmaceutiques en France....more

Hogan Lovells

Successful product launches across the EU, UK, and U.S.

Hogan Lovells on

We were pleased to welcome industry leaders to our Life Sciences and Health Care Horizons event in Boston for the first time since the pandemic. At the event, Hogan Lovells attorneys Eliza Andonova, Ina Brock, Kristin...more

Bergeson & Campbell, P.C.

Council of the EU Approves Conclusions on the Opportunities of the Bioeconomy

On April 25, 2023, the Council of the European Union (EU) announced that it approved the conclusions on the opportunities of the bioeconomy in light of current challenges, with special emphasis on rural areas. Using biomass...more

American Conference Institute (ACI)

[Event] C5’s 16th Annual Forum on Pharma & Biotech Patent Litigation in Europe - May 23rd - 24th, Amsterdam, Netherlands

Hosted by C5, the 16th Annual Forum on Pharma & Biotech Patent Litigation in Europe returns 23-24 May, at the DoubleTree by Hilton Amsterdam Central Station, Amsterdam with curated programing for you to gain the knowledge and...more

Latham & Watkins LLP

Life Sciences Law Review - 11th Edition, France Chapter

Latham & Watkins LLP on

The eleventh edition of The Life Sciences Law Review covers a total of 24 jurisdictions, providing an overview of legal requirements of interest to pharmaceutical, biotechnology and medical device companies. The chapters are...more

Hogan Lovells

JPM2023 Trendspotting: successful early access in the EU

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As the industry readies itself for the January 2023 pilgrimage to the J.P. Morgan Healthcare Conference (JPM) and Biotech Showcase in San Francisco, our market-leading life sciences and health care industry team has prepared...more

Hogan Lovells

Gene therapy development in Europe brings layers of liability risks

Hogan Lovells on

The investments in Advanced Medicinal Products (ATMPs) that use gene therapy, somatic cell therapy, and engineered tissues for preventing, treating, or curing human diseases probably represent the biggest innovation in the...more

McDermott Will & Emery

Intellectual Property & Health | News To Know – June 2022

McDermott Will & Emery on

RUSSIA RESPONDS TO WESTERN SANCTIONS WITH PATENT RETALIATION - On March 6, 2022, the Russian government retaliated against the West’s imposition of sanctions by issuing a decree permitting patented innovations to be used...more

Hogan Lovells

Is your CTGT patent portfolio ready for the UPC?

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The introduction of the Unitary Patent and the corresponding Unified Patent Court (UPC) system is set to transform the patent litigation landscape in the European Union (EU). The potential impact on the business success of...more

Proskauer - Life Sciences

Preparing for Europe’s Unified Patent Court

After years of contemplation and delays, Europe’s Unified Patent Court will be operational in about one year. U.S.-based Life Sciences patent applicants should start preparing now to ensure that their applications withstand...more

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