News & Analysis as of August 28, 2025

Biotechnology

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Read guidance, analysis, and updates on the myriad issues arising from the global response to the COVID-19 pandemic. Updated hourly every day, the insights published here are written by leading lawyers and law firms helping to make sense of insurance, employment, tax, securities, M&A, risk management, and every other consideration touched by this crisis. Follow the channel for a daily email brief of the latest and best updates. less -

RFK Jr., HHS Pull the Plug on Federal Funding for mRNA Vaccine Research and Development

ArentFox Schiff on 8/26/2025

On August 5, the US Department of Health and Human Services (HHS) announced a significant change in its vaccine development strategy, ending its support for mRNA vaccine projects under the Biomedical Advanced Research and...more

European Commission Approves Moderna’s Updated COVID-19 Vaccine

Goodwin on 8/19/2025

On July 30, 2025, Moderna announced that the European Commission (EC) granted marketing authorization for the updated formulation of Moderna’s COVID-19 vaccine Spikevax®. The updated vaccine targets the LP.8.1 variant of...more

Lexicography: Clear And Unequivocal

Sheppard Mullin Richter & Hampton LLP on 7/22/2025

This Federal Circuit opinion analyzes lexicography in the context of claim construction. Alnylam Pharmaceuticals owns U.S. Patent Nos. 11,246,933 (parent) and 11,382,979 (child). These patents relate to biodegradable...more

Health Care Executive Orders And Legal Actions: Part Six

McGuireWoods Consulting on 3/24/2025

On March 14, 2025, President Trump rescinded a number of Biden-era executive orders (EOs), two of which are health related. Executive Order 13994 (2021): The Ensuring a Data Driven Response to COVID-19 and Future...more

Trends in 2024 Securities Class Actions: AI and Biotech Cases On the Rise, Second Circuit Bounces Back

Cooley LLP on 2/14/2025

Cornerstone Research recently issued its 2024 Year in Review report examining recent trends in securities class action filings. For the second year in a row, the number of securities class action filings saw an uptick,...more

Healthcare Issues to Watch Following the FY2024 Spending Deal

Foley Hoag LLP on 4/9/2024

Six months into the fiscal year, Congress has finally passed FY2024 appropriations. It was a painstaking process, which many expected to include policy victories that both sides could celebrate. Instead, the spring work...more

Healthcare Industry Team 2023 Year in Review

BakerHostetler on 1/19/2024

As we approach the conclusion of another transformative year, we are excited to present our comprehensive year-end review, shedding light on the trends shaping the healthcare market in 2023. Our team’s keen insights and...more

PMB performs as pharma groups repurpose their portfolios

White & Case LLP on 2/3/2023

After a year of historic profits in 2021 following the mass roll-out of COVID-19 vaccines and related treatments, big pharma companies armed with cash for deals have been shifting their attention - Overall, pharma, medical...more

Pharma Investment Trend Report: What We’re Watching in 2023

King & Spalding on 1/16/2023

2022 was a big year for the pharmaceutical and biotechnology sectors. Novel technologies emerged at a rapid clip. The Food and Drug Administration (“FDA” or the “Agency”) approved over forty novel drugs and biologics and...more

AI Trends For 2023 - Bioinformatics

MoFo Tech on 12/13/2022

From improving genomic sequencing to discovering new drug formulations, AI plays a key role in advancing biomedical research. In particular, the field of bioinformatics, which involves the collection and interpretation of...more

Window on Washington – Vol. 6, Issue 35

Clark Hill PLC on 9/21/2022

Outlook for This Week in the Nation’s Capital - Congress. The House and Senate are both in session this week. Senate Majority Leader Chuck Schumer (D-NY) filed cloture last week on the Kigali amendment to the Montreal...more

COVID-19 Vaccination and the Fetal Cell Line Conundrum for Employee Religious Objections

Epstein Becker & Green on 8/11/2022

The Novavax COVID-19 vaccine recently received emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) for individuals 18 and older, making Novavax the fourth COVID-19 vaccine to receive either...more

Decoded - Technology Law Insights, Volume 3, Issue 14

Spilman Thomas & Battle, PLLC on 7/21/2022

Is the U.S. Finally Getting a Comprehensive Cybersecurity and Data Protection Law? What You Need to Know About the Proposed American Data Privacy and Protection Act - In the beginning of the 2000s, as a result of the...more

Seizing Opportunity: The post-pandemic future of US life sciences M&A 2022

Mintz on 6/14/2022

As we predicted in the previous edition of this report, 2021 turned out to be a very strong year indeed for US life sciences dealmaking, marked by high transaction values and volumes as the industry continued on its...more

The Proposed WTO IP Waiver: Just What Good Can It Do? -- An Analysis

McDonnell Boehnen Hulbert & Berghoff LLP on 3/25/2022

As posted Monday, BIO (the Biotechnology Innovation Organization) provided a link to the supposed compromise agreement reached recently to permit WTO member states to waive patent protection for "subject matter required for...more

M&A drives issuance in busy healthcare space

White & Case LLP on 2/9/2022

Following a year of healthy activity, M&A deals in the pipeline are set to sustain leveraged finance issuance in the pharmaceutical, medical and biotech sector in the months ahead - Lender appetite for exposure to the...more

Delaware Court of Chancery Declines to Dismiss Investment Firm from Stockholder Derivative Suit

Goodwin on 12/23/2021

Delaware Court of Chancery Declines to Dismiss Investment Firm from Stockholder Derivative Suit; Delaware Chancery Court Dismisses Majority of Claims Alleging that California Biotech Firm Profited from Nonpublic Information...more

Healthcare M&A on track to set new record in 2021

White & Case LLP on 12/21/2021

Heightened interest in medical suppliers, contract research organizations and biotech firms resulted in an impressive year for healthcare dealmaking- Dealmaking within the pharma, medical and biotech sector continued from...more

What was Fascinating in 2021 for Biotech

Spilman Thomas & Battle, PLLC on 12/17/2021

2021 was a fascinating year in biotech, especially for legal issues. Of course, 2021, as the second year of a global pandemic, must be viewed in context with 2020....more

COVID-19 Weekly Newsletter: Average Case Rates Drop From Delta Wave’s Heights

Faegre Drinker Biddle & Reath LLP on 11/1/2021

This week’s newsletter details the latest developments in the process of approving COVID-19 vaccines for children ages 5-11, a vaccine that produced promising clinical results, and new studies revealing insights about...more

Decoded: Technology Law Insights, Volume 2, Issue 20

Spilman Thomas & Battle, PLLC on 10/13/2021

The Story of Henrietta Lacks and the Biotechnology Company Accused of Selling Her Cells for Profit - These two articles (Newsweek and Fierce Biotech) describe the new lawsuit by the Henrietta Lacks Estate surrounding the...more

Decoded: Technology Law Insights, Volume 2, Issue 19

Spilman Thomas & Battle, PLLC on 9/30/2021

Biotechnology Can Fight Climate Change—but Trade Negotiators Need to Act - "Emerging biotechnology, such as gene-editing, can safely and effectively change our planet's future for the better." Why this is important:...more

[Event] Drug & Medical Device Litigation - December 7th - 8th, New York, NY

American Conference Institute (ACI) on 9/14/2021

The premier event for drug and medical device product liability lawyers to gain essential winning litigation strategies. ACI’s 26th Annual Flagship Conference on Drug and Medical Device Litigation is returning to New York...more

What is a COVID-19 Vaccine Intellectual Property Waiver?

Sunstein LLP on 8/11/2021

While over 48% of the U.S. population is fully vaccinated, only about 15% of the world is. Such disparities have caused members of the World Trade Organization (WTO), such as India and South Africa, to call for a waiver of...more

COVID-19 Report for Life Sciences and Health Care Companies - August 2021

Hogan Lovells on 8/4/2021

The COVID-19 Report is a compilation of coronavirus news, analysis, and insights from around the world to help life sciences and health care companies stay current in this challenging time. In Wednesday's Report: U.S....more

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