News & Analysis as of

Biotechnology Medical Devices

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

Morgan Lewis

SEC Focus on the Life Sciences Industry: What to Expect and How to Prepare

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The life sciences sector remains a critical area of focus for the US Securities and Exchange Commission (SEC) under the current administration. Companies operating in the healthcare, pharmaceutical, biotechnology, and medical...more

Arnall Golden Gregory LLP

FDA in the “Computer Age” — AI Adoption Accelerates as Staffing Shrinks

Neil Young once sang of adapting to a world ruled by data and digital minds in “Computer Age.” Today, that vision feels increasingly real as the Food and Drug Administration turns to artificial intelligence (“AI”) in the face...more

Knobbe Martens

Bipartisan Law Introduced to Clarify Patent Eligibility

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For the past decade, controversy regarding the laws of patent eligibility has created uncertainty in the minds of inventors and investors, especially in the biotechnology, medical diagnostics, and software industries adjacent...more

Goodwin

Securities Litigation Against Life Sciences Companies 2024 Year in Review

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Welcome to our ninth annual report on US securities class actions filed against publicly traded life sciences companies, which include pharmaceutical, biotechnology, medical device, and healthcare companies....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

Goodwin

The 43rd Annual J.P. Morgan Healthcare Conference Starts Today - A Who’s Who in Biologics at this Year’s Conference

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The JP Morgan Healthcare Conference (“JPM”) “is the largest and most informative health care investment symposium in the industry which connects global industry leaders, emerging fast-growth companies, innovative technology...more

Orrick, Herrington & Sutcliffe LLP

Life Sciences Snapshot – Q4 2024 – A Quarterly Report on Financing Trends

Since the previous quarter’s Life Sciences Snapshot, robust dealmaking activity in Q3 has launched YTD life sciences VC deal activity to near parity with 2023 figures, firmly positioning 2024 as the year to break the two-year...more

Goodwin

Life Sciences M&A Trends for 2023 and 2024 (Through End of Q3) in Greater China

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Goodwin is presenting a two-part publication series covering life sciences trends involving license deals, M&A, and financing for Greater China’s life sciences sector. ...more

Robinson+Cole Data Privacy + Security Insider

Neural Data Included in CCPA Amendments

As we outlined in our previous blog article, California recently became the second state to enact a law safeguarding consumer brain data, following a similar law passed by Colorado in April. Both state laws prevent the sale...more

Wilson Sonsini Goodrich & Rosati

FDA Issues Multiple Guidances Supporting Clinical Trial Innovation

In September 2024, the U.S. Food and Drug Administration (FDA) issued three guidance documents to support different clinical trial approaches, including trials that implement decentralized elements, trials that allow...more

Alston & Bird

Feds Continue to Reform Approach to Regulation of Biotech Products

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Our Food & Beverage and FDA teams explore a plan from a trio of federal agencies that seeks to implement regulatory reform and update the Coordinated Framework for the Regulation of Biotechnology....more

McDermott Will & Emery

Pharma and MedTech Services Investment Summit 2024

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The inaugural Pharma and MedTech Services Investment Summit brought together C-suite executives, senior private equity professionals, investment bankers and other industry leaders for a deep dive into the investment...more

Hogan Lovells

Top legal issues to think about in China-related licensing transactions

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This article provides a general overview of certain Chinese legal considerations for licensing and collaboration deals in the life sciences industry. In particular, this article focuses on two types of transactions...more

Knobbe Martens

Boston Scientific Agrees to Acquire Silk Road Medical in $1.16B Deal

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Press releases report that Boston Scientific (BSX) has entered an agreement to acquire medical device developer Silk Road Medical in a deal totaling $1.16 billion. Silk Road Medical has reportedly developed devices and...more

Wilson Sonsini Goodrich & Rosati

The Life Sciences Report – June 2024

This latest edition features articles on biotech client Siolta Therapeutics, the use of safety and efficacy findings to extend drug exclusivity periods, life sciences venture financings for clients in 2023, and updated USPTO...more

McDermott Will & Emery

[Event] Pharma and MedTech Services Investment Summit 2024 - May 2nd, San Francisco, CA

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YOUR SOURCE FOR SUCCESS IN PHARMA AND DEVICE SERVICES INVESTING - Join C-suite executives, senior private equity professionals, investment bankers and other industry leaders for a deep dive into the investment...more

Lowenstein Sandler LLP

The BIOSECURE Act: Proposed New Legislation Could Affect U.S. Companies’ Plans to Contract With Chinese Biotechnology Companies

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The U.S. Senate and the U.S. House of Representatives are both considering legislation that could have a serious impact on the ability of U.S. biotechnology, drug, and medical device companies to do business with...more

Knobbe Martens

Antitrust Lawsuit Brought Against Drug Manufacturer Based on Its Allegedly Improper Listing of Device Patents in the FDA’s Orange...

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As we recently discussed, the Federal Trade Commission (“FTC”) sent warning letters to certain drug manufacturers regarding their purportedly improper listing of device patents in the Food and Drug Administration’s (“FDA”)...more

American Conference Institute (ACI)

[Event] FCPA & Anti-Corruption for the Life Sciences Industry - May 9th - 10th, New York, NY

Hosted by the American Conference Institute, the 19th Annual FCPA & Anti-Corruption Conference for the Life Sciences Industry returns for another exciting year with carefully researched programming based on critical findings...more

BCLP

Lessons From the Growth of Femtech and Women’s Health

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BCLP’s Healthcare & Life Sciences Practice Group recently partnered with EMIG Digital Health Group to co-host an in-person breakfast seminar and networking event focused on FemTech. Specialists from across the FemTech and...more

Orrick, Herrington & Sutcliffe LLP

Life Sciences Snapshot – A Quarterly Report on Financing Trends – Q4 2023

This report series examines quarterly trends in life sciences venture investment. Key findings for Q3 2023 include: Life sciences VC deal value in Q3 2023 totaled $7.7 billion, representing an uptick from last quarter...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

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

Goodwin

Common FDA Bioresearch Monitoring Violations: Updates from FY 2022 to Now

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The Bioresearch Monitoring (BIMO) Program, operated by the U.S. Food and Drug Administration (FDA), conducts on-site inspections and data audits in order to effectively monitor the compliance of all FDA-regulated research....more

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