Popular, Biden Administration, Pharmaceutical Industry

Sights and Sounds from the Antitrust Section’s 2025 Spring Meeting

Morrison & Foerster LLP on 4/9/2025

Antitrust experts from across the globe convened in Washington, D.C. on April 2–4, 2025 to discuss new enforcement policies and share updates on current issues in antitrust. We provide the key highlights from numerous panels...more

Trump Executive Order Signals Drug Pricing Reforms Likely on the Horizon

Morgan Lewis - Health Law Scan on 1/28/2025

Through the issuance of Inauguration Day executive orders, the Trump Administration signaled its apparent intent to tackle drug pricing reforms over the next four years. However, Biden-era policies are likely to limit a...more

The Fate of the “Last Gasp” of the Biden FTC: Will Its Legacy Survive the Trump Administration?

Axinn, Veltrop & Harkrider LLP on 1/27/2025

In the days leading up to President Trump’s inauguration, the Biden FTC rushed to initiate major lawsuits and to tie a bow on various antitrust policy efforts. In a series of dissenting statements, the minority Republican...more

FTC Sues Nation’s Largest PBMs, Continuing Biden Administration’s Antitrust Scrutiny of the Life Sciences Sector

Wilson Sonsini Goodrich & Rosati on 9/27/2024

The Biden administration’s antitrust scrutiny of the life sciences industry continued this week as the Federal Trade Commission (FTC) filed an administrative complaint against the nation’s largest pharmacy benefit managers...more

Biden Administration Proposes Biosimilar Substitution Without Interchangeability

Goodwin on 3/28/2024

The Biden Administration recently released a 2025 Budget Proposal which includes permitting biosimilar substitution without the Food and Drug Administration’s (“FDA”) separate determination of interchangeability. ...more

Recent Healthcare-Related Artificial Intelligence Developments

Sheppard Mullin Richter & Hampton LLP on 2/27/2024

AI is here to stay. The development and use of artificial intelligence (“AI”) is rapidly growing in the healthcare landscape with no signs of slowing down. From a governmental perspective, many federal agencies are embracing...more

New Artificial Intelligence Executive Order Contains Numerous Healthcare Implications

Holland & Knight LLP on 11/7/2023

President Joe Biden on Oct. 30, 2023, signed a sweeping executive order (EO) and invoked the Defense Production Act to establish the first set of standards for using artificial intelligence (AI) in healthcare and other...more

US Officially Recognizes Medical Use and Safety of Cannabis: The Top 6 Things to Know About Schedule III and the Process Ahead

Vicente LLP on 9/1/2023

On August 30, 2023, the federal government formally acknowledged the medical use and low potential of abuse for cannabis, with the US Department of Health and Human Services (HHS) recommending that cannabis be rescheduled to...more

President Biden Signs Executive Order on Biotechnology and Biomanufacturing Innovations

McDonnell Boehnen Hulbert & Berghoff LLP on 9/15/2022

On Monday, September 12th, President Biden signed an Executive Order entitled "Advancing Biotechnology and Biomanufacturing Innovation for Sustainable, Safe and Secure American Bioeconomy." The Executive Order (in Section...more

Weekly Update for Government Contractors and Commercial Businesses – February 2022

PilieroMazza PLLC on 2/4/2022

DOJ Recovers Over $5.6 Billion From Fraud and False Claims Act Matters in FY 2021: 6 Key Takeaways - On February 1, 2022, the U.S. Department of Justice (DOJ) announced that it had recovered more than $5.6 billion in Fiscal...more

Biosimilars 2021 Year in Review

Fish & Richardson on 1/12/2022

2021 saw several important milestones in the biosimilars space, including the much anticipated first interchangeable designations by FDA and the approval of the first ophthalmology biosimilar. The biosimilar market also...more

Asia Life Sciences – Navigating US-China Relations

Morgan Lewis on 10/7/2021

Life sciences companies are increasingly global, with the nationalities of individuals in management teams and offices often spanning the major life sciences centers across the United States, in China, and around the world....more

Washington Healthcare Update - August 2021 #3

McGuireWoods Consulting on 8/17/2021

This week in Washington: Senate passes infrastructure bill; Senate passes budget resolution with reconciliation instructions; Congress enters recess with House members to return Aug. 23....more

President Biden Signs Executive Order on Promoting Competition

Wilson Sonsini Goodrich & Rosati on 7/13/2021

On July 9, 2021, President Biden signed the Executive Order on Promoting Competition in the American Economy (EO), which states that "excessive market concentration threatens basic economic liberties, democratic...more

Congressional Investigations in the 117th Congress: U.S. Senate Oversight Activities Ramp Up

King & Spalding on 7/6/2021

Six months into the 117th Congress, the U.S. Senate has recently increased its oversight activities following a slow start. Since April, newly empowered Democratic Members have launched or requested more than 20 inquiries...more

Biden Administration supports waiver of WTO IP rights for COVID-19: Next steps for innovators

Hogan Lovells on 5/12/2021

On 5 May 2021, U.S. Trade Representative Katherine Tai announced that the Biden Administration would support India and South Africa’s request for a World Trade Organization (WTO) waiver of intellectual property (IP) rights...more

False Claims Act Enforcement in 2021: A Look Ahead

Foley Hoag LLP - White Collar Law &... on 3/31/2021

This is the sixth in our First 100 Days series examining important trends in white collar law and investigations in the early days of the Biden administration. Our previous entry discussed ESG initiatives by the SEC. Up next...more

Vaccine Production And State Intervention In The U.S.

MoFo Life Sciences on 3/31/2021

During the COVID-19 pandemic, governments across the globe have become increasingly involved in the private sector. State-owned enterprises have long been common in Asia, but the pandemic has increased their prominence in...more

FDA Appointment Signals Increased Attention on Medical Device Cybersecurity

Sheppard Mullin Richter & Hampton LLP on 2/10/2021

At the beginning of February, the US Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) appointed Professor Kevin Fu as the first ever Acting Director of Medical Device Cybersecurity. Fu’s...more

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