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 September 4, 2025, President Trump published an Executive Order titled “Implementing the United States–Japan Agreement.” The Executive Order, which follows President Trump’s July 22 announcement of a trade agreement...more
The Trump Administration’s handling of antitrust enforcement issues is generally viewed as a wild-card — meaning there are issues of concern or focus that may not fit the “traditional” antitrust enforcement model. Depending...more
President Donald Trump confirmed this week that his administration is actively reviewing the possibility of reclassifying marijuana as a less dangerous drug. This move would follow through on a proposal made under the Biden...more
Our Drug Pricing and Market Access team tracks recent developments in healthcare reform, the Medicaid Drug Rebate Program, the 340B Program, Medicare, and state law....more
We have seen plainly what happens when disasters interrupt domestic healthcare supply chains: from N-95 masks to saline, our healthcare system has struggled in the face of hurricanes and a pandemic, as just two recent...more
In 2025, Life Sciences and Health Care (LS&HC) companies face rapidly evolving regulatory paradigms that create transactional risks and require daily monitoring. After more than 70 national elections in 2024, the dust hasn’t...more
McDermott+ is pleased to bring you Regs & Eggs, a weekly Regulatory Affairs blog by Jeffrey Davis. August 21, 2025 – Within the next few weeks, the Trump administration is expected to issue the second Make America Healthy...more
News Briefs - Over 75% of Health Organizations Targeted by Ransomware Over Year - More than three-quarters of healthcare survey respondents said their organizations were targeted by ransomware in the past 12 months, and 53...more
Below is a tracker of healthcare-related executive orders (EOs) issued by the Trump administration, including overviews of each EO and the date each EO was signed. We will regularly update this tracker as additional EOs are...more
On May 12, 2025, U.S. President Donald Trump signed an executive order (EO) titled “Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients.” In part, the EO revisits previous efforts during Trump's...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
The Executive Order aims to bolster the resilience of the United States’s pharmaceutical supply chain by stockpiling Active Pharmaceutical Ingredients (“APIs”) for critical medicines in the Strategic Active Pharmaceutical...more
The Trump administration is considering changing the U.S. patent maintenance fee structure from the existing three fixed flat fees to an annual, value‑based “tax” model where patent holders would pay 1%–5% of the estimated...more
The Trump administration has issued numerous pharma-focused executive orders, including “Lowering Drug Prices by Once Again Putting Americans First,” “Regulatory Relief to Promote Domestic Production of Critical Medicines,”...more
In follow-up to the May 12th “Delivering Most Favored Nation Prescription Drug Pricing to American Patients” Executive Order, President Trump issued letters to seventeen manufacturers (Letters), reiterating the mandate for...more
Through our Venable FDA Pulse series, we report on critical developments within the Food and Drug Administration (FDA or Agency) that may affect the Agency’s structure and stakeholder interactions. ...more
The WSJ reports the Trump administration wants to charge patent holders 1% to 5% of their patent’s value to maintain the patent after grant. If implemented, this would mark a dramatic departure from the traditional flat-fee...more
On April 29, 2025, a pharmaceutical company filed the latest constitutional challenge to the qui tam provision of the False Claims Act (“FCA”) when it appealed in the United States Court of Appeals for the Third Circuit a...more
The One Big Beautiful Bill Act ("OBBB") expands exemptions for orphan drugs from mandatory Medicare price negotiations and modifies their eligibility timeline....more
On July 27, 2025, President Trump announced that the U.S. and European Union (“EU”) have reached a trade deal. Pursuant to the Fact Sheet released by the White House on July 28th, the U.S. will impose a 15% tariff on all EU...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
Designed for busy in-house counsel, compliance professionals, and anti-corruption lawyers, this newsletter summarizes some of the most important international anti-corruption law and enforcement developments from the past...more
Just before Americans celebrated the Fourth of July, on June 30, 2025, antitrust enforcers from both the Federal Trade Commission (FTC) and Department of Justice Antitrust Division (DOJ) hosted the first of two listening...more