Episode 374 -- Justice Department Resumes FCPA Enforcement with New, Focused Guidance
Cruising Through Change: The Auto-Finance Industry’s New Era Under Trump Unveiled — The Consumer Finance Podcast
2023 CRA Rule Repeal: Lessons to be Learned
The Classification of Gasoline & Gasoline Fumes as a Carcinogen: Considerations for Corporate Executives & Attorneys
Hot Topics in International Trade - Let's Be Serious-Supply Chain Audits
Regulatory Rollback: Inside the CFPB’s FCRA Guidance Withdrawal — The Consumer Finance Podcast
Cruising Through Change: The Auto-Finance Industry’s New Era Under Trump Unveiled — Moving the Metal: The Auto Finance Podcast
Regulatory Rollback: Inside the CFPB's FCRA Guidance Withdrawal — FCRA Focus Podcast
Innovation in Compliance: The Critical Importance of Mobile Application Security: Insights from Subho Halder
2 Gurus Talk Compliance: Episode 53 – The AI as a Whistleblower Edition
Compliance Tip of the Day: Internal Controls for Third Parties
Healthcare Enterprise Risk Management
GILTI Conscience Podcast | Navigating Brazil's New Transfer Pricing Landscape: A Shift to OECD Standards
Importance of Compliance Management in times of transition
Great Women in Compliance: From Hotline to Headline: The DOJ’s Whistleblower Awards Reboot with Mary Inman and Liz Soltan
Compliance into the Weeds: Autonomous AI Whistleblowing Misconduct
Understanding MALPB Charters: A Collaborative Approach to Banking Innovation — Payments Pros – The Payments Law Podcast
Law Firm ERGs Under Scrutiny: Navigating Compliance, Risk, and Culture - On Record PR
Compliance Tip of the Day: Risk Assessments and Internal Controls
As we head into BIO 2025 in Boston, our teams are closely watching trends in biotech and how those affect financings, business development, IP protection, risk, and litigation strategy. Here are eight key trends we’re...more
A recent federal court decision highlights the delicate balance between U.S. Food and Drug Administration (FDA) guidance and trade dress protections for drugs administered in a tablet or capsule form. Last month, a district...more
Biosimilar Litigations include litigations relating to biosimilar/follow-on products of CDER-listed reference products. Litigations between biosimilar applicants/manufacturers and reference product sponsors as well as...more
The Federal Circuit recently issued decisions in a pair of appeals that provide guidance about when international filers of abbreviated Biologics License Applications (aBLAs) are subject to jurisdiction in the United States....more
This post is part of MoFo’s 2025 Intersection of AI and Life Sciences blog series. In this blog series, we explore how artificial intelligence is revolutionizing research, innovation, and patient care in the life sciences....more
Entresto® (sacubitril/valsartan) - Case Name: Novartis Pharms. Corp. v. Becerra, Civ. No. 24-cv-2234 (DLF), 2024 WL 4492072 (D.D.C. Oct. 15, 2024) (Friedrich, J.) Drug Product and Patent(s)-in-Suit: Entresto®...more
On January 20, 2025, Justice O’Reilly of the Federal Court dismissed Bayer’s judicial review of the Minister of Health’s decision to list Canadian Patent No. 2,970,315 (315 Patent) on the Patent Register eight days after it...more
ProAir® HFA (albuterol sulfate) - Case Name: Teva Branded Pharm. Products R&D, Inc. v. Amneal Pharms. of NY, LLC, No. 2024-1936, 2024 WL 5176737 (Fed. Cir. Dec. 20, 2024) (Circuit Judges Prost, Taranto, and Hughes...more
The District of Delaware recently denied a motion to dismiss a patent infringement complaint involving gene editing technology that sought relief under the Safe Harbor Provision of the Hatch-Waxman Act. Specifically, the...more
The Biologics Price Competition and Innovation Act of 2009 (BPCIA) was passed as part of health reform signed into law by President Obama in March 2010. This year, the BPCIA turns 10. While the U.S. Biosimilars Pathway has...more
Legal, Regulatory and Commercial Perspectives on the International Biosimilars Marketplace - The Global Biosimilars market is expected to grow robustly. Market watchers anticipate that Europe in particular will experience...more