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?
Podcast — Drug Pricing: How Might the Trump Administration Transform FDA Enforcement Activities?
AI and Pharmacovigilance Under the FDA's New Emerging Drug Safety Technology Program – The Good Bot Podcast
Podcast — Drug Pricing: What’s in the New CMS Medicaid Final Rule?
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 217: Japanese Investment in North Carolina’s Life Sciences Industry with David Robinson of Maynard Nexsen
12 Days of Regulatory Insights: Day 3 - State AG Oversight in the Health Care Industry — Regulatory Oversight Podcast
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 216: Patient Advocacy and Healthcare Policy Change with Melissa Horn of the Arthritis Foundation
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 214: Pharma Manufacturing in North Carolina with Ed Hernandez of Eli Lilly
Podcast — Drug Pricing: Takeaways From the Chicago Medicaid Drug Rebate Program Summit
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 209: North Carolina’s Life Sciences Industry with Laura Gunter of NCLifeSci
Podcast — Drug Pricing: How the Demise of Chevron Deference and Other Litigation May Impact the Pharmaceutical Industry
Understanding Pharmacy Benefit Managers: The PBM Landscape Explained
False Claims Act Insights - Are All Healthcare “Kickbacks” Subject to FCA Liability?
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 204: Accelerating Life Sciences Startups with James Chappell of SCbio
Walgreens to Pay $300 Million to Settle DOJ Claims Over Invalid Opioid Prescriptions - Walgreens Boots Alliance has agreed to pay more than $300 million to resolve allegations brought by the US Department of Justice (DOJ)...more
As temperatures in the Northeast have made it feel more like winter than spring, it’s only fitting that we begin our April Insurance Update with a case from Alaska. There, the Alaska Supreme Court decides for the first time...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
Virginia AG Jason Miyares, along with a bipartisan coalition of eight other state AGs and in coordination with six other AGs, has announced a settlement in principle with Mylan Inc. to resolve allegations that it contributed...more
News Briefs - Congress Extends Telehealth Flexibilities for Another Six Months - Pandemic-related telehealth flexibilities set to expire March 31 have recently been extended for another six months as federal lawmakers approve...more
Earlier this month, the Law Court weighed in on a hot-button legal issue—the potential liability of opioid manufacturers for the costs of the drug epidemic. In Eastern Maine Medical Center v. Walgreen Company, the Law Court...more
On January 30, the U.S. Food and Drug Administration approved Journavx (suzetrigine) 50 milligram oral tablets, a first-in-class non-opioid analgesic, to treat moderate to severe acute pain in adults. It is the first new type...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 U.S. Department of Justice (“DOJ”) recently announced that in fiscal year 2024 (“FY2024”), settlements and judgments under the False Claims Act (“FCA”) exceeded $2.9 billion. Over $2.4 billion of such settlements and...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
In past years we have discussed how opioid-related enforcement efforts have remained a top federal and state priority (here, here, and here). In 2024, opioid-related enforcement efforts continued across the entire opioid...more
The most notable decision in the bankruptcy world in 2024 was the Supreme Court’s decision in Purdue Pharma. Harrington v. Purdue Pharma, L.P., 144 S. Ct. 2071 (2024). At the heart of the fight in Purdue Pharma were...more
On December 13, the U.S. Department of Justice (DOJ) intervened in a False Claims Act (FCA) lawsuit alleging that CVS Pharmacy Inc. and its subsidiaries improperly sought federal reimbursement for prescriptions filled in...more
McKinsey & Company, Inc., has entered into a deferred prosecution agreement (DPA) to resolve a federal criminal investigation into its advice to Purdue Pharma L.P. (Purdue) on how to increase sales of OxyContin, and a civil...more
A national class action on behalf of multiple Canadian governments to recover opioid epidemic healthcare costs simplifies the aggregation, prosecution, and determination of claims that span geographic boundaries. That is what...more
In the third episode of our special 12 Days of Regulatory Insights podcast series, Chris Carlson is joined by Barry Boise, a seasoned partner in Troutman Pepper’s Health Sciences Litigation practice group, to explore the...more
On June 27, 2024, the United States Supreme Court decided the Purdue Pharma appeal. In a five-to-four decision, the Supreme Court held that a bankruptcy court may not extend to non-debtors the benefits of a Chapter 11...more
The Department of Justice announced one if its most aggressive and wide-ranging enforcement actions to date, a coordinated two-week operation spanning 32 federal districts. The orchestrated effort involved the FBI, HHS-OIG,...more
The Supreme Court’s day started with the specter of yet another leak of a reproductive rights decision having occurred....more
A coalition of AGs reached a settlement in principle with Amneal Pharmaceuticals, Inc., to resolve allegations that it contributed to the opioid epidemic in its role as a drug manufacturer. According to the coalition, Amneal...more
Previous editions of Re:Torts (It’s (Still) Important Enough to Get It Right; Opioid Public Nuisance Question) have covered decisions that addressed whether various states permit public nuisance claims in connection with the...more
The U.S. Attorney’s Office for the District of New Jersey recently announced a $750,000 settlement with Sentynl Therapeutics Inc., a California-based specialty pharmaceutical company. The settlement resolves allegations that...more
Prescription drug fraud has long been a focus for government regulators, but it has taken on new significance in the wake of America’s opioid crisis. The U.S. Department of Justice (DOJ), Department of Health and Human...more
In the grand experiment of American democracy, it is often said that states serve as laboratories, testing policies that challenge the status quo without risking the stability of the whole. Oregon, known in recent years for...more
Alaska AG Treg Taylor has reached a settlement with CVS Pharmacy, Inc. to resolve allegations that the company violated Alaska’s Unfair Trade Practices and Consumer Protection Act by allegedly dispensing opioid-containing...more