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
In Harrington v. Purdue Pharma L.P., the Supreme Court held that the Bankruptcy Code does not authorize a bankruptcy court to grant a release and injunction that extinguishes direct claims against nondebtor third parties...more
Pfizer Settles Its Subsidiary’s Kickback Allegations for Nearly $60 Million - Pfizer Inc. agreed to pay over $59,746,277 to resolve allegations that its wholly owned subsidiary, Biohaven Pharmaceutical Holding Company...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
OxyContin® (oxycodone HCl) - Case Name: Purdue Pharma L.P. v. Accord Healthcare, Inc., No. 2023-1953, 2024 WL 5244764 (Fed. Cir. Dec. 30, 2024) (Circuit Judges Prost, Reyna, and Taranto presiding; Opinion by Prost, J.)...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
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
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
Case Name: Purdue Pharma L.P v. Accord Healthcare Inc., Civ. No. 22-913-WCB, 2024 WL 4120717 (D. Del. Sept 9, 2024) (Bryson, J.) Drug Product and Patent(s)-in-Suit: OxyContin® (oxycodone HCl); U.S. Patent No. 11,304,908 (“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 Supreme Court’s day started with the specter of yet another leak of a reproductive rights decision having occurred....more
Multistate groups of AGs reached two settlements related to claims involving the U.S. opioid epidemic. Publicis Health, LLC settled with a coalition consisting of all AGs from every state, territory, and the District of...more
David Conaway reports on a recent Chapter 11 plan of reorganization submitted by Purdue Pharma (Oxycontin) to resolve a mass tort claim. The Supreme Court of the United States (SCOTUS) is having difficulty swallowing the...more
There is longstanding controversy concerning the validity of third-party release provisions in non-asbestos trust chapter 11 plans that limit the potential exposure of various non-debtor parties involved in the process of...more
Non-consensual third-party releases are provisions in reorganization plans that release non-debtor parties from liability to other non-debtor parties without the consent of all potential claimholders. These releases are...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
Earlier this month, the U.S. Department of Justice (DOJ) Civil Division's Consumer Protection Branch (CPB) released its first-ever annual "recent highlights" report. The report describes the CPB's accomplishments from October...more
Two recent decisions by U.S. District Courts have rejected attempts to include nonconsensual third party releases in chapter 11 reorganization plans. These rulings suggest third party releases may be facing increasing push...more
A plutocratic clan has upped its ante by $1.5 billion in an apparently successful bet that using bankruptcy courts, mediation, and offering to settle giant claims in the opioid abuse and drug overdose crisis will be cheaper...more
Big Pharma is blazing a legal trail that wealthy corporations are racing to follow. The corporatists are using a new approach to crush patients and other consumers who seek justice in the civil system with claims that drug...more
On February 3, 2022, as part of a series of recent decisions addressing third-party releases, Bankruptcy Judge John T. Dorsey of the Bankruptcy Court for the District of Delaware (the “Bankruptcy Court”) confirmed the chapter...more
While Republicans and a handful of Democrats in Congress may be filling campaign coffers and pleasing wealthy corporations to the nth degree during the current lawmaking session, regular folks have reason to be aghast at how...more
In a landmark opioid painkiller case, a federal bankruptcy judge has approved what potentially may be a $10-billion settlement. It included a plutocratic clan winning sweeping protections from further civil lawsuits by...more
Just as attorneys generals for more than a dozen states inch toward a multibillion-dollar settlement with a drug maker faulted for its big role in the start of the opioid abuse and drug overdose crisis, that health menace is...more
While too many of us get overdosed with clownish depictions - from doctors, hospitals, insurers, and corporations, especially Big Pharma firms - of how the civil justice system operates, it’s always worth a reminder of the...more
Over the last two months, McKinsey & Company — one of the world’s largest consulting firms — resolved matters with all 56 state attorneys general regarding investigations into its role in providing marketing and consulting...more