Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 247: Reimagining Cell Therapy for Solid Tumors with Ming-Wei Chen and Fangheng Zhou of RephImmune
HHS Policy Changes, Supreme Court Rulings, and the DOJ-HHS False Claims Act Working Group
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 246: The Next Generation of Treatment for Alzheimer's and Parkinson’s with Neal Goodwin and Pawel Krysiak of Jaya Bio
AI Today in 5: August 11, 2025, The ACHILLES Project Episode
False Claims Act Insights - Bitter Pills: DOJ Targets Pharmacies for FCA Enforcement
Key Discovery Points: BYOD Case Law Covering Subpoenas and Employee Handbooks
Daily Compliance News: June 23, 2025, The Is Walmart Cool Edition
Taking the Pulse: A Health Care & Life Sciences Video Podcast | Episode 239: Understanding the 340B Pricing Program with Chuck Melendi of Disruptive Dialogue
Unexpected Paths to IP Law with Dan Young and Colin White
Navigating Legal Strategies for Covering GLP-1s in Self-Insured Medical Plans — Employee Benefits and Executive Compensation Podcast
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 234: Life-Saving Collaboration in the Life Sciences Industry with John Crowley, President & CEO of BIO
AGG Talks: Cross-Border Business Podcast - Episode 28: How Life Sciences Companies Can Create a Culture of Compliance When Expanding to the U.S. Market
How Life Sciences Companies Can Create a Culture of Compliance When Expanding to the U.S. Market
Podcast - Hot Topics in FDA Regulation: GLP-1s, LDTs, AI and More
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 231: Advancing the Life Sciences Industry with Kendalle O’Connell of MassBio
Compliance Program Effectiveness: Keep it Streamlined and Strategic
AGG Talks: Cross-Border Business Podcast - Episode 26: U.S. Enforcement Trends Targeting Foreign Pharmaceutical and Medical Device Manufacturers
Podcast — Drug Pricing: 2025 J.P. Morgan Healthcare Conference Takeaways and Outlook
Prescribing GLP-1 Medications: Be Aware of Legal Limitations
Podcast — The Growth Rocketship: How BridgeBio’s Hub and Spoke Portfolio Strategy Set the Market for the Future of Biotech — Then, Now, and What’s Next?
President Trump Announces Higher Tariff Rates Effective August 1st- After announcing an extension of the reciprocal tariff rates from July 9, 2025, to August 1,2025, President Trump published letters which were sent to...more
In response to travel restrictions imposed during the COVID-19 pandemic, the U.S. Food and Drug Administration (“FDA”) began conducting remote regulatory assessments (“RRAs”) of medical products companies and other...more
President Trump’s executive orders and legislative proposals from Congress leverage FDA to help lower drug prices, address anti-competitive practices, and accelerate generic drug approvals....more
Key Takeaways - Regulatory Relief for U.S. Manufacturing: The EO streamlines FDA and EPA processes to encourage domestic pharmaceutical production....more
On Monday, May 12, President Donald Trump signed an Executive Order (EO) titled, “Delivering Most-Favored-Nation Prescription Drug Pricing to Americans,” aimed at reducing prescription drug prices by implementing a...more
President Donald Trump on May 12, 2025, issued an executive order (EO) titled "Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients" and an accompanying Fact Sheet, "President Donald J. Trump...more
On May 6, the US Food and Drug Administration (FDA) announced plans to expand its use of unannounced inspections at foreign manufacturing facilities that “produce foods, essential medicines, and other medical products...more
Recently, underscoring a commitment to national security, the White House and the Food and Drug Administration (FDA) issued separate communications that aim to bolster domestic drug manufacturing while tightening oversight of...more
The White House on May 5, 2025 issued an executive order requiring the US Food and Drug Administration to find ways to facilitate the opening of new drug manufacturing sites in the United States while also increasing the...more
The Trump administration has intensified its America First Trade Policy initiatives by announcing three new investigations under Section 232 of the Trade Expansion Act of 1962 by the Department of Commerce. As foreshadowed in...more
Section 232 investigations determine whether the targeted U.S. imports threaten to impair U.S. national security. At the conclusion of a Section 232 investigation (which can last for up to 270 days), the President must...more
The Trump administration is pursuing additional national security investigations that will likely lead to tariffs on imports of semiconductors, semiconductor manufacturing equipment (“SME”), and derivative articles,...more
Over the past few weeks, the Trump Administration has announced three new investigations under Section 232 of the Trade Expansion Act of 1962 into whether imports of pharmaceuticals, semiconductors, and critical minerals and...more
On April 15, 2025, President Trump issued an executive order titled “Lowering Drug Prices by Once Again Putting Americans First.” The order reaffirms and seeks to expand on policy initiatives introduced during the president’s...more
Effective April 5, the United States imposed a 10% baseline tariff on imports from nearly all countries, excluding products from Canada and Mexico, and those products contained in the Harmonized Tariff Schedule of the United...more
The Department of Commerce (Commerce) has launched three Section 232 investigations covering pharmaceuticals, pharmaceutical ingredients, and their derivative products; semiconductors and semiconductor manufacturing equipment...more
This article provides an overview of the most recent tariff updates affecting businesses operating within the semiconductor, pharmaceutical, and critical mineral industries. Below we outline recent tariff exclusions for...more
The Trump Administration has formally launched three separate national security investigations under Section 232 of the Trade Expansion Act of 1962 including on: 1) imports of semiconductors (including downstream electronic...more
The U.S. Department of Commerce announced that it has initiated a Trade Expansion Act of 1962 Section 232 investigation to determine whether imports of pharmaceutical products and ingredients pose a national security risk to...more
On April 14, 2025, the US Department of Commerce Bureau of Industry and Security (BIS) announced the initiation of investigations into the effects on US national security of imports of pharmaceuticals and pharmaceutical...more
On April 1, 2025, the Secretary of Commerce initiated, pursuant to President Trump’s directive, two new investigations under Section 232 of the Trade Expansion Act of 1962 (Section 232), one on imports of pharmaceuticals and...more
It is the end of an unprecedented week in trade that roiled financial markets and challenged businesses trying to assess the impacts on their supply chains....more
Since taking office in January 2025, the Trump Administration has announced, imposed, or reimposed various tariff-related restrictions on articles imported into the United States. These proposed tariffs and their...more
On September 13, 2020, President Trump issued an Executive Order seeking to establish most favored nation ("MFN") pricing for Medicare drug payments. The Trump Administration's Order, 'Lowering Drug Prices by Putting America...more
On August 6, President Trump issued an Executive Order (EO) titled “Ensuring Essential Medicines, Medical Countermeasures and Critical Inputs Are Made in the United States.” The far-reaching EO seeks to ensure the domestic...more