Episode 332 -- Deep Dive into SEC’s Internal Controls and Cybersecurity Settlement with R&R Donnelly
Mitigating Political-Law Risk
The Preferred Return Podcast | AIFMD II – Implementation Begins
Why ESG Matters?
Meeting the Proposed SEC Climate Disclosure Requirements
California Regulation of Charitable Fundraising Platforms Part 2 - Reporting Due Diligence, Recordkeeping, and Disclosure Rules
ESG Masterclass — ESG and Impact Investing
The Justice Insiders Podcast - Human Beings: Cybersecurity's Most Fragile Attack Surface
JONES DAY TALKS®: Court Grants Stay on SEC’s Climate Disclosure Rule, but Companies Should Continue Preparations
ESG Masterclass — ESG and Politics
Ad Law Tool Kit Show – Episode 5 – Surviving an FTC Investigation
SEC’s New Cyber Rules for Publicly Traded Companies — The Consumer Finance Podcast
PLI's inSecurities Podcast - Commissioner Uyeda on “the Perils of Regulation by Theory and Hypothesis”
PLI's inSecurities Podcast - Addressing the “Netflix Problem” in Securities Regulation
What Nonprofit Leaders Need To Know About the Corporate Transparency Act
December 1st Deadline to Adopt Executive Compensation Clawback Policies — The Consumer Finance Podcast
How to Fix the Cyber Incident Reporting Mess--DHS Weighs In
ESG Essentials: What You Need To Know Now - Episode 16 - ESG Backlash
Regulatory Phishing Podcast - The Impact of Cybersecurity Compliance on Corporate Transactions
The Justice Insiders Podcast: Incidents in the Material World: SEC Adopts New Cybersecurity Rules
Introduction - On June 18, 2024, the Federal Trade Commission (“FTC”) unanimously agreed to submit a comment supporting a recent proposed U.S. Patent and Trademark Office (“PTO”) rule that would mandate the disclosure of all...more
On February 7, 2024, the Federal Court dismissed Takeda’s action under subsection 6(1) of the Patented Medicines (Notice of Compliance) Regulations in relation to dexlansoprazole (Takeda’s DEXILANT). Justice Furlanetto...more
Some chemical innovators have found the recent Supreme Court decision in Amgen v. Sanofi to suggest that chemical inventions will be subject to new and draconian disclosure standards going forward. A few have even suggested...more
The United States Patent and Trademark Office (USPTO) imposes a Duty of Disclosure, Candor and Good Faith (Duty of Disclosure) on all individuals associated with the filing and prosecution of a patent application...more
Under the Federal Law “On drugs circulation” (Law), information on state registration of drugs in Russia shall be publicly available. Pursuant to Art. 37(1) of the Law, MoH-s obligation is to disclose information regarding...more
IN THIS ISSUE: - Shire’s VYVANSE patent valid, prohibition order issued - First judicial consideration of Vanessa’s Law: Health Canada must disclose requested clinical trial data - PMPRB News - Patented Medicine...more
On June 25, 2018, the United States Supreme Court agreed to review the Federal Circuit's decision in Helsinn Healthcare v. Teva Pharmaceuticals, No. 17-1229. In Helsinn, the Federal Circuit considered whether the America...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
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
The Biologics Price Competition and Innovation Act (BPCIA) provides for a series of disclosures between a biosimilar applicant and the innovator company, commonly referred to as the “patent dance.” 42 U.S.C. §262(l). While...more
The 2014 BIO International Convention begins next week in San Diego. If you are planning on attending, you probably already know that the amount of information and opportunities available at BIO can be daunting. Therefore,...more