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?
ACI's virtual 6th Annual Passport to Proficiency on Rx Drug Pricing & Rebate Fundamentals will help you master the fundamentals, comprehend the consequences of new developments, and prepare for the complexities and nuances of...more
The Administration issued Executive Order (“EO”) 14293: Regulatory Relief to Promote Domestic Production of Critical Medicines on May 5, 2025...more
In July, the Senate Armed Services Committee passed its version of the FY 2025 National Defense Authorization Act (NDAA), which would make substantial changes to the rules for determining the “country of origin” of drugs for...more
A House committee will vote May 15 on an updated version of the BIOSECURE Act, legislation that would block federal contracts to five Chinese biotechnology companies and other drugmakers with certain China-based companies in...more
The Biomedical Advanced Research and Development Authority (BARDA) held its first in-person BARDA Industry Day (BID) since the beginning of the COVID-19 pandemic in Washington, D.C., on November 13-14, 2023. BID is an annual...more
I'm not saying that anyone from the Biden administration was reading my blog post last week on drug shortages, and maybe it's just a coincidence that the White House announced new efforts to strengthen supply chains less than...more
Since its enactment in 2017, Public Law No. 115-92 has significantly boosted the availability of medical products that protect and treat military personnel. Designed to overcome the unique challenges posed by military medical...more
Establish firm footing in the world of government contracting with this advanced course of study in Big Four pharmaceutical purchasing. ACI’s Big Four Pharmaceutical Pricing Boot Camp will introduce and reinforce core...more
On February 7, 2023, the U.S. Department of Justice (DOJ) announced its fiscal year (FY) 2022 False Claims Act (FCA) statistics. Utilizing DOJ’s FY 2022 Data Table and comparing back to our FY 2021 coverage, MoFo’s FCA team...more
Designed for busy in-house counsel and compliance professionals, this newsletter seeks to bring you up to speed on key federal and state False Claims Act (FCA) developments, with links to primary resources. Each quarter, we...more
President Biden announced his signing of an Executive Order launching a major effort to enhance U.S. capabilities in biotechnology and biomanufacturing last week (see "President Biden Signs Executive Order on Biotechnology...more
Reports identify weaknesses and introduce plans to strengthen certain critical supply chains - On February 24, 2022, the Biden Administration released a Plan to Revitalize American Manufacturing and Secure Critical Supply...more
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
In the case that tested the limits of the “fake it till you make it” approach to a startup business, on January 3, 2022, a jury in the U.S. District Court for the Northern District of California convicted Elizabeth Holmes,...more
For several years, policy-makers and commentators have expressed concern about the resilience of the United States’ pharmaceutical supply chain. Current U.S.-based manufacturing capabilities have been at the forefront of...more
The Biden Administration on June 8, 20201, released findings from a 100-day interagency domestic supply chain assessment of critical products and outlined a series of steps it will take in order to strengthen U.S. critical...more
A recent health care fraud conspiracy case resulted in federal prison sentences for six participants, serving as a warning to pharmacy owners and their employees. The Case- Mohamed Abdalla is a licensed pharmacist who...more
In Washington: The House voted 232-197 to impeach President Trump for a second time on a charge of inciting insurrection over the Jan. 6 siege on the U.S. Capitol that left five people, including a Capitol Police officer,...more
On October 30, 2020 the FDA published a list of essential medicines, medical countermeasures, and critical inputs as required by President Trump’s August 2020 Executive Order on Ensuring Essential Medicines, Medical...more
On August 4, 2020, a bipartisan coalition of over 30 attorneys general led by California Attorney General Xavier Becerra and Louisiana Attorney General Jeff Landry sent a letter request to United States Health and Human...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
On August 6, 2020, U.S. President Donald Trump issued his much-anticipated "Buy American" Executive Order (EO), intended to increase and support domestic manufacture and Federal government procurement of "essential...more
Effective August 13, 2020, an Interim Rule jointly issued by the Department of Defense (DoD), the General Services Administration (GSA), and the National Aeronautics and Space Administration (NASA) that amends the Federal...more
We are pleased to provide you with the third annual installment of our Life Sciences and Health Care Horizons guide. For each of these guides, we have asked our industry thought leaders throughout the world to write about...more
The Supreme Court held that the FCA’s extended limitations period is available to relators in qui tam cases even when the government declines to intervene. Lower courts continued to divide over the first-to-file bar,...more