Taxing Intelligence: AI's Role in Modern Tax Administration
Podcast - An Overview of State Attorney General Consumer Protection Enforcement
LathamTECH in Focus: Move Fast, Stay Compliant
Work This Way: A Labor & Employment Law Podcast | Compliance Clarity for Federal Contractors with Joan Moore and Mim Munzel of Arbor Consulting Group
AI Today in 5: August 6, 2025, The Rethinking Compliance Episode
Compliance Tip of the Day: M&A Domestic Issues
Episode 381 -- NAVEX's 2025 Annual Hotline Report
Podcast - Regulating AI in Healthcare: The Road Ahead
Data Driven Compliance: Understanding the ECCTA and Its Impact on Fraud Prevention with Vince Walden
Wild Times for the Community Reinvestment Act
Mid-Year Labor & Employment Law Update: Key Developments and Compliance Strategies
Can Food Really Be Medicine? Transforming Health Care One Bite at a Time – Diagnosing Health Care Video Podcast
Point-of-Sale Finance Series: Unpacking Leases and RTO Models — The Consumer Finance Podcast
Suluki Secrets: Behind the Scenes of Reasonable Investigations — FCRA Focus Podcast
Understanding BBB Ratings: Building Trust and Mitigating Risks — Regulatory Oversight Podcast
Compliance and AI: Navigating Risk Management in the AI Era with Gaurav Kapoor
Data Driven Compliance: Understanding the UK’s New Failure to Prevent Fraud Offense with Sam Tate
Regulatory Rollback: Legal Challenges and Opportunities in Earned-Wage Access — Payments Pros – The Payments Law Podcast
Regulatory Rollback: Legal Challenges and Opportunities in Earned-Wage Access — The Consumer Finance Podcast
LathamTECH in Focus: Tech Deals: The Emerging Focus of FDI Regulators?
In April 2025, the U.S. Food and Drug Administration (FDA) released a landmark guidance titled “Roadmap to Reducing Animal Testing in Preclinical Safety Studies,” outlining its commitment to advancing New Approach...more
In the first half of 2025, the Rx IP Update team reported on a number of developments in Canadian life sciences IP and regulatory law. Below are our top stories....more
In its June 2025 meeting, the European Medicines Agency’s (“EMA”) Committee for Medicinal Products for Human Use (“CHMP”) adopted positive opinions for six biosimilar medicines. ...more
Hetlioz® (tasimelteon) - Case Name: Vanda Pharms., Inc. v. FDA, Civ. No. 23-280 (TSC), 2025 WL 485401 (D.D.C. Feb. 13, 2025) (Chutkan, J.) Drug Product and Patent(s)-in-Suit: Hetlioz® (tasimelteon); U.S. Patent No. , a...more
The Federal Circuit held in Merck Sharp & Dohme B.V. v. Aurobindo Pharma USA, Inc., 23-2254 that a reissued patent receives patent term extension (PTE) based on the issue date of the original patent, not the reissue patent,...more
On March 13, 2025, the Federal Circuit issued a decision in Merck Sharp & Dohme B.V. v. Aurobindo Pharma USA, Inc., No. 23-2254 (Fed. Cir. 2025) that clarifies how patent term extension (PTE) is calculated for reissue...more
Last month, the U.S. Food and Drug Administration (the “FDA”) announced in a Declaratory Order the resolution of the shortage of semaglutide injection products Wegovy and Ozempic (the “February Declaratory Order”). On March...more
Obesity and diabetes have been two of the greatest public health challenges for decades. Many different diets and fads have promised the public a quick fix and a path to losing excess weight or resolving their diabetic...more
Novo Nordisk recently made headlines petitioning FDA to stop the compounding of its blockbuster GLP-1 products so it can sell its patented semaglutide drugs exclusively. Compounding is the practice of creating new drug...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
As we previously reported, on December 19, 2024, the Patented Medicine Prices Review Board (PMPRB) released its Draft Guidelines for PMPRB Staff regarding Administrative Process for Excessive Price Hearing Recommendation...more
The Federal Trade Commission (FTC) has called attention in the past year to its perception of the influence that branded pharmaceutical companies have over the price of beneficial drugs. Most recently, the agency has asserted...more
Canada is an attractive market for pharmaceutical manufacturers. While universal healthcare does not currently extend to drugs in an outpatient setting, most Canadian consumers have some form of drug coverage through...more
2022 heralded the next chapter for biosimilars in the United States, including U.S. Food and Drug Administration approval of biosimilars in new therapeutic areas, additional interchangeable designations, and litigation...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
In early July 2018, the United States Food and Drug Administration (FDA) issued a final guidance document titled, “ANDA Submissions – Amendments to Abbreviated New Drug Applications under GDUFA – Guidance for Industry." A...more