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 22, 2025, FDA suspended the biologics license for Ixchiq, one of only two marketed chikungunya vaccines. The decision to suspend comes only a few weeks after FDA approved a Safety Labeling Change supplemental...more
In early August, the National Association of Attorneys General, led by its 2025 President, New Hampshire Attorney General John Formella, hosted the Presidential Initiative Summit in Portsmouth, New Hampshire. General...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
Virginia AG Jason Miyares, along with a bipartisan coalition of eight other AGs, announced a $720 million settlement with eight opioid drug manufacturers to resolve allegations that they contributed to the opioid epidemic....more
All 55 AGs from the states and territories have settled with Purdue Pharma, Inc., and its owners, members of the Sackler family, to resolve allegations related to the company’s role in fueling the opioid crisis....more
Taking a note from Sir Elton John’s 1983 hit, “I’m Still Standing,” the Food and Drug Administration’s Office of Prescription Drug Promotion issued two enforcement actions (one Notice of Violation and one Warning Letter)...more
The National Association of Attorneys General (NAAG) sent a letter on behalf of a bipartisan coalition of 38 state and territory AGs requesting that the FDA act to protect consumers from counterfeit forms of weight loss and...more
On January 16, 2025, the Food and Drug Administration (FDA) issued an order banning FD&C Red No.3 in food and ingested drugs.1 Food and ingested drug manufacturers who use Red No. 3 have until January 15, 2027, or January 18,...more
New York AG Letitia James, along with a bipartisan coalition of 15 other state AGs and additional parties, has reached a settlement in principle with members of the Sackler family and Purdue Pharma, Inc., to resolve...more
The US Food and Drug Administration (FDA) has revoked its authorization for the use of FD&C Red No. 3, also known as Red Dye No. 3. Issued on January 15, 2025, the ban will go into effect for food (including dietary...more
The U.S. Food and Drug Administration (“FDA”), in partnership with the Department of Justice (“DOJ”), pursued significant and, in some cases, precedent-setting enforcement actions in 2024. The government continued to...more
This week, DEA announced it has entered into a settlement agreement with Morris & Dickson Co., LLC (“Morris & Dickson”), resolving the protracted dispute born out of a May 2, 2018 Order to Show Cause (“OTSC”) and Immediate...more
In recent months, the Food and Drug Administration (FDA) announced several recalls related to natural supplements that were found to contain tadalafil and its analogs, the active ingredients in Viagra and Cialis. In its...more
Despite news of additional COVID-19-related deaths and infections in America, central bankers appear to have bought at least one day of peace for US markets, which posted strong gains on a late surge on Monday, breaking a...more
Continuing progress on the initiatives announced in its Biosimilars Action Plan in July 2018, the Food and Drug Administration (FDA) released information about several important biosimilar-related actions on February 3, 2020....more
Two announcements made by FDA in late October signal a marked change to FDA’s regulatory approach to “homeopathic” drugs. On October 25, 2019, FDA withdrew the 1988 Compliance Policy Guide (“CPG”) 400.400 Conditions Under...more
INTRODUCTION - A wave of recent indictments unsealed against opioid distributors and their executives signifies that the U.S. Department of Justice (“DOJ”) has embarked on a criminal crackdown after years of civil...more
The opioid crisis in America is now well known, affecting a staggering number of people directly or indirectly and occupying a regular place in media reports and political discussions. In addition to potential public health...more
The scourge of opioid-related addiction and risk is a well-known story among the pain management community. In response to this federally declared public health crisis, government prosecutors are upping their game. Almost...more
FDA Issues Guidance on Concentrated Caffeine - The U.S. Food and Drug Administration (FDA) has released guidance clarifying that "dietary supplements containing pure or highly concentrated caffeine in powder or liquid...more