SkadBytes Podcast | Tech’s Shifting Landscape: Five Trends Shaping the Conversation
From Banks to FinTech: The Evolution of Small Business Lending — The Consumer Finance Podcast
From Banks to FinTech: The Evolution of Small Business Lending — Payments Pros – The Payments Law Podcast
Podcast - Navigating the Updated SF-328 Form
Five Tips for a New Public Company Director
Doc Fees Decoded: The Price of Paperwork in Auto Sales — Moving the Metal: The Auto Finance Podcast
PODCAST: Williams Mullen's Benefits Companion - Gag Clause Prohibitions
Episode 371 -- DOJ's New Corporate Enforcement Program
Podcast - New Guidance on Complying with FTC Rule on Deceptive and Unfair Fees
Welcoming a New Payment Pro: Jason Cover Joins the Payments Pros Podcast — Payments Pros – The Payments Law Podcast
(Podcast) The Briefing: Influencer Fail – ALO Yoga & Influencers Named in $150M Class Action Lawsuit for FTC Violations
The Briefing: Influencer Fail – ALO Yoga & Influencers Named in $150M Class Action Lawsuit for FTC Violations
Compliance into the Weeds: Leaving on a (Qatari) Jet Plane
LEGAL ALERT | NAD Finds Kevin Hart’s Social Media Disclosures Insufficient in Monitoring Decisions
Choosing Your LDA Reporting Path for 2025
Bar Exam Toolbox Podcast Episode 305: Spotlight on Civil Procedure (Part 2 – Discovery)
Compliance Tip of the Day: Clarifying Compliance Mandates
Consumer Finance Monitor Podcast Episode: How to Use the Restatement of Consumer Contracts - A Guide for Judges
Compliance Tip of the Day: Corporate Leaks and Compliance
Greenhushing: What It Is & Why It Matters
The US Food and Drug Administration has announced a renewed focus on a long-considered issue—whether FDA should release complete response letters (CRLs) issued to drug or biologic applicants. Specifically, on July 10, 2025...more
The Food and Drug Administration (“FDA” or the “Agency”) user fee negotiations may have hit an iceberg, but it did not sink all the legislative riders that accompanied this summer’s House and Senate bills. Buried within the...more
FDA has announced the Advancing Real-World Evidence (RWE) Program, which aims to improve the quality and acceptability of RWE-based approaches that can meet regulatory requirements in support of labeling for effectiveness...more
Signed into law on December 27, 2020, the Biological Product Patent Transparency Act (42 U.S.C. § 262(k)(9)) requires biological reference product sponsors to provide to the US Food and Drug Administration within 30 days of...more
PMPRB News - PMPRB releases scoping paper relating to proposed amended Regulations - As previously reported, on December 2, 2017, Canada’s Governor-in-Council published proposed Regulations Amending the Patented...more
Genentech filed a complaint last Friday in the District of Delaware against Pfizer for infringement of 40 patents under the BPCIA regarding PF-05280014, Pfizer’s biosimilar of Herceptin® (trastuzumab). According to the...more
In Sandoz Inc. v. Amgen Inc. (which you can read more about here), the Supreme Court held that 42 USC § 262(l)(9)(C) sets forth the exclusive federal remedy for failing to provide a copy of the biosimilar application to the...more
Federal Circuit Interprets Statutory Requirements for Biosimilar Regulatory Pathway - Amgen Inc., v. Sandoz Inc., (Fed. Cir. July 21, 2015): In a case of first impression, the U.S. Court of Appeals for the Federal...more
The Federal Circuit today denied the petitions for rehearing by the panel and rehearing by the en banc Court filed by both parties in Amgen v. Sandoz. Amgen had petitioned for rehearing on the panel's decision that the...more
Congress passed the Biologics Price Competition and Innovation Act (“BPCIA”) in 2009 in an effort to bring biosimilar drug products to market. The goal was for the BPCIA to mimic for biologic drugs the Hatch-Waxman statute...more
On July 21, 2015, the Federal Circuit decided the Amgen v. Sandoz appeal in a case of first impression regarding the interpretation of the disclosure and notice provisions of the Biologics Price Competition and Innovation Act...more
On July 21, 2015, the Federal Circuit issued a key decision regarding the meaning of various provisions of the Biologics Price Competition and Innovation Act (BPCIA). See Amgen Inc. v. Sandoz Inc., Fed. Cir. Case No....more
In a seriously fractured decision, the Federal Circuit construed the provisions of the Biologics Price Control and Innovation Act (BPCIA) today in Amgen v. Sandoz. In doing so, the Court limited the information available to...more