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
One of the fastest ways to garner unwanted attention as a publicly-traded life sciences company is to be accused by either a regulator or stockholder that the company disclosed materially misleading information about the...more
Corporate Governance and Securities Law Developments - Directors Can Be Held Liable for Failure to Oversee “Mission Critical” Regulatory Compliance - On October 1, the Delaware Court of Chancery refused to dismiss a...more
Recently, the Securities and Exchange Commission (SEC) issued an order charging a publicly traded pharmaceutical company with violations of Regulation FD as a result of selectively disclosing material, nonpublic information....more
Regulation Fair Disclosure was passed in 2002 to fill what many saw as a regulatory gap – the selective disclosure of material non-public information by issuers. Essentially the Regulation – now known as Reg FD – requires a...more
On August 20, 2019, the SEC charged a pharmaceutical company with violations of Regulation FD based on its sharing of material, nonpublic information with sell-side research analysts on two separate occasions without also...more
On Aug. 20, 2019, the Securities and Exchange Commission (SEC) announced that it had charged public pharmaceutical company TherapeuticsMD, Inc. for violations of Regulation FD and Section 13(a) of the Exchange Act related to...more
The United States Securities and Exchange Commission (SEC) announced yesterday, August 20, 2019, that it charged TherapeuticsMD, Inc., a pharmaceutical company headquartered in Boca Raton, Florida, with violations of...more
The SEC charged TherapeuticsMD Inc., a pharmaceutical company headquartered in Boca Raton, Florida, with violations of Regulation FD based on its sharing of material, nonpublic information with sell-side research analysts...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