News & Analysis as of

Biotechnology Life Sciences 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

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

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

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

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

Hogan Lovells

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

Hogan Lovells on

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

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

Hogan Lovells on

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

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

Goodwin

Global Biosimilar Update

Goodwin on

The European Commission has approved mAbxience’s bevacizumab biosimilar, MB02, for marketing in Europe. As we previously reported, MB02, which will be known as Alymsys and Oyavas, is intended for the treatment of colon or...more

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

The New Exclusive European Licensee of Cenobamate: Angelini Pharma Acquires Emerging Swiss Biotech Company Arvelle Therapeutics

The Italian pharmaceutical company Angelini Pharma announced on January 4, 2021, that it will acquire emerging Swiss biotech company Arvelle Therapeutics for a total aggregate valuation of up to $960 million. Angelini Pharma...more

Hogan Lovells

EMA publishes list of COVID-19 treatments that have been the subject of the Agency’s guidance

Hogan Lovells on

On 30 October 2020, the European Medicines Agency (“EMA”) published a list containing all COVID-19 treatments and vaccines that have so far been the subject of scientific advice or informal guidance from EMA’s pandemic Task...more

Hogan Lovells

EU Clinical Trials Regulation to apply from December 2021

Hogan Lovells on

On 12 June 2020, the management board of the European Medicines Agency (EMA) announced December 2021 as the date of entry into application of the EU Clinical Trials Information System (CTIS). ...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

Akin Gump Strauss Hauer & Feld LLP

MedTech Update 2020: Legal and Regulatory Issues to Watch For in the Medical Technology Industry in the New Year

Medical device and diagnostics companies and laboratories should anticipate significant legal, regulatory and market changes in 2020 that will have a lasting impact on the industry. From revisions to how the government...more

Hogan Lovells

European Medicines Agency’s clarification regarding re-testing exemption for imported advanced therapy medicinal products

Hogan Lovells on

On 21 August 2019, the European Medicines Agency (EMA) published questions and answers regarding imported advanced therapy medicinal products (ATMP). The document focuses on the possibility of batch controls exemption for...more

Hogan Lovells

View from the Horizon: Pricing and financial regulation of health products in France

Hogan Lovells on

On June 27 the third edition of our new global series, Life Sciences and Health Care Horizons, took place in Paris with discussions focused on the pricing and financial regulation of health products after the latest reforms....more

McDermott Will & Emery

European SPC Manufacturing Waiver Goes into Force

McDermott Will & Emery on

Newly issued EU Regulation 2019/933 provides supplementary protection certificate exemptions for exporting and stockpiling active pharmaceutical ingredients and medicinal products if certain anti-abuse requirements are met....more

McDermott Will & Emery

Digital Health in the United Kingdom: The New Regulatory Environment Under the Medical Device Regulation

The MDR and other recent developments in the health care regulatory landscape pose new opportunities and challenges for medical software companies and investors in digital health in the United Kingdom. Although the regulatory...more

Hogan Lovells

Pharmaceutical Sector remains under Scrutiny of EU Competition Enforcers

Hogan Lovells on

On 28 January 2019, the European Commission published its Report to the Council and Parliament regarding “Competition enforcement in the pharmaceutical sector (2009-2017)” (“Report“). ...more

Hogan Lovells

New Brexit Q&A provides several examples in relation to the “placing on the EU market” of products including medical devices

Hogan Lovells on

On 1 February 2019, the European Commission published a new Q&A document to give further guidance on the Notice to stakeholders-withdrawal of the United Kingdom and EU rules in the field of industrial products (“the Notice”)....more

43 Results
 / 
View per page
Page: of 2

"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:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide