News & Analysis as of August 29, 2025

Pharmaceutical Industry

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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

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

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

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

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

[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

Healthcare displays strong deal activity post-pandemic

White & Case LLP on 7/30/2021

The value of healthcare M&A in H1 surpassed pre-pandemic levels - Healthcare M&A (including pharma, biotech and medical) saw strong growth over the first half of 2021 as investors continued to pursue deal opportunities in...more

BIO Declaration on Global Access to COVID-19 Vaccines and Treatments and Role of IP

McDonnell Boehnen Hulbert & Berghoff LLP on 6/28/2021

In a message distributed to Biotechnology Innovation Organization (BIO) members, Dr. Michelle McMurry-Heath, BIO President and CEO, released a declaration signed by the corporate and organizational leaders of 209 global...more

IP Waiver for COVID-19 Vaccines: What the United States’ Support Means in Practice

Proskauer - The Patent Playbook on 6/22/2021

On May 5, 2021, the Biden Administration announced its support for waiving intellectual property protections for COVID-19 vaccines. Understandably, the news made headlines and stirred passionate reactions from the medical...more

Science Does Not Support the Latest COVID Hysteria

McDonnell Boehnen Hulbert & Berghoff LLP on 5/14/2021

In a time of a global pandemic, with antivaxxer and anti-science sentiments running rife, and when combinations of fear, distrust, and paranoia are rampant, it is easy for important results from basic science to become fodder...more

The mRNA Patent and Competitive Landscape: Pioneers, Litigation Outlook and Big Pharma’s Next Moves (Part III)

Rothwell, Figg, Ernst & Manbeck, P.C. on 5/10/2021

In Part I of this series providing a summary of the mRNA IP and competitive landscape through one year of the COVID-19 pandemic, we focused on market players BioNTech, Moderna and CureVac; in Part II, we discussed Translate...more

The Road to Hell Is Paved with What Everybody Knows

McDonnell Boehnen Hulbert & Berghoff LLP on 5/7/2021

And everybody knows that suspending patent rights is necessary to provide sufficient vaccine to stem the global pandemic caused by the SARS-CoV-2 virus known as COVID-19. It is always a sign of intellectual weakness and pack...more

BIO & IPO Issue Statements on Biden Administration's Support for Proposed WTO Waiver

McDonnell Boehnen Hulbert & Berghoff LLP on 5/7/2021

Yesterday, United States Trade Representative Katherine Tai announced "the Biden-Harris Administration's support for waiving intellectual property protections for COVID-19 vaccines" (see "Biden Administration Supports Waiver...more

The mRNA IP and Competitive Landscape: Translate BIO; Arcturus; eTheRNA and Other Startups; and LNP Technology (Part II)

Rothwell, Figg, Ernst & Manbeck, P.C. on 5/3/2021

In Part I of this three-part series, we focused on three mRNA technology market players: BioNTech, Moderna and CureVac. In this second post, we will focus on Translate BIO, Arcturus Therapeutics, and eTheRNA and discuss...more

Sen. Tillis Asks Biden Administration to Oppose WTO Waiver Proposal

McDonnell Boehnen Hulbert & Berghoff LLP on 4/22/2021

Last month, the Biotechnology Innovation Organization (BIO) and Pharmaceutical Research and Manufacturers of America (PhRMA) sent separate letters urging the Biden Administration to join the European Union, United Kingdom,...more

How Biotechnology Is Helping to Stop COVID-19 and Solve the World’s Problems with James Greenwood, senior policy advisor at DLA...

Furia Rubel Communications, Inc. on 4/7/2021

In this episode of On Record PR, Sarah Larson goes on record with James Greenwood, senior policy advisor at DLA Piper, retired CEO of the Biotechnology Innovation Organization, and former congressman representing Bucks...more

How Biotechnology Is Helping to Stop COVID-19 and Solve the World’s Problems with James Greenwood, Senior Policy Advisor at DLA...

Furia Rubel Communications, Inc. on 4/6/2021

In this episode of On Record PR, Executive Vice President Sarah Larson goes on record with James Greenwood, senior policy advisor at DLA Piper and retired CEO of the Biotechnology Innovation Organization (BIO), to discuss the...more

Industry Coalition Supports Continued Efforts to Oppose Waiver Proposal

McDonnell Boehnen Hulbert & Berghoff LLP on 3/30/2021

Earlier today, a group of fifteen industry and trade organizations sent a letter to five members of the Biden Administration, to express their strong support for the Administration's work to leverage international mechanisms...more

BIO and PhRMA Urge Biden Administration to Oppose Proposed WTO TRIPS Waiver

McDonnell Boehnen Hulbert & Berghoff LLP on 3/12/2021

One year ago today, World Health Organization Director-General Tedros Adhanom declared the COVID-19 outbreak to be a pandemic. At the time of the announcement, the WHO noted that there were 118,000 cases reported globally,...more

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