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?
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
The U.S. Court of Appeals for the First Circuit, in United States v. Regeneron, has joined the Sixth and Eighth Circuits in adopting the “but-for” standard to find that a violation of the Anti-Kickback Statute (AKS) triggers...more
Find this week’s updates on 340B litigation to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to provide you with a quick...more
While federal funding for addiction treatment programs and research is being cut, more than $50 billion is being distributed to state and local programs from opioid-related lawsuits. There is great debate on the use of these...more
Two long weeks until August recess - This is the last week with both chambers in session until September, and things are relatively slow as lawmakers count down the days to the month-long August recess. With reconciliation...more
Last month, the United States Department of Justice (“DOJ”) issued its “Civil Division Enforcement Priorities” memorandum, memorializing a shift from its predecessor administration’s policy on gender‑affirming healthcare...more
The U.S. government is pushing to redomesticate the manufacturing of pharmaceutical, biotech, gene therapy, and medical device products, both to bolster U.S. manufacturing generally and to address continuing shortages of...more
Here are curated AG and federal regulatory news stories highlighting key areas in which state and federal regulators’ decisions are having an impact across the US: •Mylan Inc. Settles Opioid Epidemic-Related Claims for $335...more
Artificial intelligence is revolutionizing life science R&D (particularly in the realm of drug discovery) and challenging the traditional "human inventorship" requirement for U.S. patents. Recent guidance from the USPTO...more
Update: The Government of Canada announced an agreement with the Yukon ($9.5 million over four years). The agreement text is available in the updated National pharmacare bilateral agreements resource....more
Canada’s Bill C-64, An Act respecting pharmacare (the “Pharmacare Act”) received royal assent on October 10, 2024 and established a framework for national pharmacare. On February 27, 2025, the Hon. Mark Holland, Canada’s...more
We previously reported on Canada’s first-ever National Strategy for Drugs for Rare Diseases, which included up to $1.4 billion in funding for provinces and territories, to be negotiated through bilateral agreements. This...more
In recent weeks, the FDA has faced significant cuts, including the layoffs of probationary employees. These employees, many of whom had been hired to fill roles left by retirees or to bolster the agency’s staffing during the...more
News Briefs - More States Taking Steps to Control P.E. in Healthcare Settings - An increasing number of states are looking to control private healthcare operations transactions, even as the Trump administration appears likely...more
Robert F. Kennedy Jr. (RFK Jr.) has been confirmed by the Senate as secretary of the Department of Health and Human Services (HHS). In this capacity, RFK Jr. will oversee 13 agencies that are critical to U.S. health policy,...more
The third quarter of this year brought numerous high-dollar False Claims Act (FCA) settlements involving a variety of industries and alleged conduct. Below are noteworthy resolutions that reflect recent enforcement trends....more
Congress is back from a long August recess. However, it is only back for a few weeks. During this window, there is only one major thing Congress must do: extend government funding past the September 30 deadline through a...more
Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more
Proposed federal legislation known as the BIOSECURE Act is being considered in both the U.S. House of Representatives and the U.S. Senate....more
U.S. universities and academic institutions rely heavily on federal grants to fund their research and generate innovations in life sciences. Universities often out-license patents protecting inventions created using federal...more
The Biden-Harris Administration recently announced various actions to lower healthcare and prescription drug costs. In one action, the National Institute of Standards and Technology (NIST) released in December 2023 a draft...more
Presented as part of its effort to lower what it views as excessive prices for prescription drugs, the Biden administration on December 7, 2023, announced the release of a proposed framework to expand the use of government...more
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
Congress was in session, and it was a busy healthcare week at the committee level, with six hearings focused specifically on health issues. On the House floor, Republicans passed the Limit, Save, Grow Act—a bill that raises...more
In a year-end $1.7 trillion spending package in late December, Congress voted to increase FDA's oversight of cosmetics and their ingredients. A portion of the bill titled the Modernization of Cosmetics Regulation Act requires...more