News & Analysis as of

Securities and Exchange Commission (SEC) Pharmaceutical Industry Publicly-Traded Companies

Skadden, Arps, Slate, Meagher & Flom LLP

FDA Pivots on Publishing Complete Response Letters, Raising SEC Disclosure and Securities Litigation Implications

On July 10, 2025, the U.S. Food and Drug Administration (FDA) announced that it was embracing “radical transparency” by publishing more than 200 Complete Response Letters (CRLs) — letters the agency issues to a sponsor when...more

Morgan Lewis - As Prescribed

FDA’s Shifting Stance on Public Disclosure of NDA and BLA Complete Response Letters – How Far Will It Go?

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

Goodwin

Securities Litigation Against Life Sciences Companies 2024 Year in Review

Goodwin on

Welcome to our ninth annual report on US securities class actions filed against publicly traded life sciences companies, which include pharmaceutical, biotechnology, medical device, and healthcare companies....more

McDermott Will & Schulte

New SEC Leadership Signals Continued Focus on FDA-Related Disclosures

Lawyers inside and outside the US Securities and Exchange Commission (SEC) have speculated that the agency’s new leadership will take a “lighter touch” when it comes to enforcement. The ultimate approach of the new SEC...more

Jones Day

SEC Prevails in Novel "Shadow Trading" Insider Trading Trial

Jones Day on

The Securities and Exchange Commission ("SEC") won at trial in its first "shadow trading" case, holding a corporate official liable for insider trading for using nonpublic information about his company's acquisition to trade...more

Vinson & Elkins LLP

Out from the Shadows: The SEC Succeeds on Shadow Insider Trading Theory

Vinson & Elkins LLP on

The Securities and Exchange Commission obtained a victory in a closely-watched trial when a jury found Matthew Panuwat liable for insider trading based on a “shadow trading” theory. The jury’s verdict, as well as increased...more

Akerman LLP - Health Law Rx

Teva FCA Decision Sheds Light on Varying Interpretations of the Elements of an FCA Claim

How could alleged kickbacks threaten to render insolvent a publicly traded company with assets (taken from its latest SEC filing) in excess of $43 billion? The answer stems from a recent decision by the United States District...more

White & Case LLP

Mixed Signals: US M&A FY 2022

White & Case LLP on

Although the record-breaking deal activity of 2021 spilled over into 2022, headwinds in the first quarter developed into a significant slowdown during the rest of 2022, with an expectation of continued slowness as we enter...more

A&O Shearman

California District Court Allows Novel SEC Insider Trading Theory To Proceed

A&O Shearman on

On January 14, 2022, Judge William Orrick of the United States District Court for the Northern District of California issued an order denying a former biopharmaceutical company executive’s motion to dismiss and allowing the...more

White & Case LLP

SEC Extends the Misappropriation Theory of Insider Trading Beyond Targets of Acquisitions to Companies “Economically Linked” to...

White & Case LLP on

In a landmark action, the US Securities and Exchange Commission ("SEC") filed a complaint alleging insider trading that expands the potential reach of insider trading law. On August 17, 2021, the SEC charged a former employee...more

BCLP

SEC Brings First Case Charging Shadow Insider Trading

BCLP on

The SEC’s filing of its first shadow trading case earlier this month signals the agency’s willingness to pursue actions based on expanded theories of insider trading liability. In a federal court complaint, the SEC on...more

Proskauer - Corporate Defense and Disputes

Stumbling Through Securities Law Challenges for COVID-19 Vaccine Developers

As the world waits to overcome the COVID-19 pandemic, publicly traded pharmaceutical companies waging in that fight are facing the multifaceted challenge of developing COVID-19 responses, informing the public of their...more

Mayer Brown Free Writings + Perspectives

Recent SEC Enforcement Actions Involving Accounting Misstatements and Non-GAAP Financial Measures

In July  2020, a publicly traded pharmaceutical company entered into a settlement with the Securities and Exchange Commission, without admitting or denying findings, and agreed to pay a financial penalty relating to various...more

Orrick, Herrington & Sutcliffe LLP

Managing and Maintaining Clinical Trial Disclosure for Publicly Traded Life Sciences Companies

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

Skadden, Arps, Slate, Meagher & Flom LLP

Skadden's 2020 Insights

Despite political and economic uncertainties, markets and deal activity were resilient in 2019, and strong fundamentals remain in place heading into 2020. Companies continue to face a challenging litigation and enforcement...more

BCLP

Securities and Corporate Governance Update – October 2019

BCLP on

This newsletter discusses noteworthy updates, key regulatory decisions and upcoming compliance reminders. In this edition, we review: ...SEC Changes Approach to Shareholder Proposal No-Action Requests ...SEC Issues...more

Orrick, Herrington & Sutcliffe LLP

What's New in Corporate Governance and Securities Law - October 18, 2019

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

Faegre Drinker Biddle & Reath LLP

SEC: Here Is When Loss Contingencies Must Be Disclosed and Reserved

When confronted with government inquiries, public companies commonly grapple with the issue of when events have escalated to the point that they are subject to disclosure obligations—or, further yet, require recognition as a...more

Stinson - Corporate & Securities Law Blog

SEC Brings Enforcement Action for Loss Contingency Disclosure

The SEC recently settled an enforcement action against Mylan N.V., claiming Mylan failed to timely disclose to investors a possible loss relating to a nearly two-year Department of Justice  probe into whether Mylan...more

Foley & Lardner LLP

Selective Disclosure Violation Results in SEC Order

Foley & Lardner LLP on

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

Dorsey & Whitney LLP

SEC Files First Reg FD Action In Years

Dorsey & Whitney LLP on

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

Dorsey & Whitney LLP

SEC Charges TherapeuticsMD with Regulation FD Violations

Dorsey & Whitney LLP on

Last week, the SEC issued a reminder that Regulation FD remains a vital element of the federal securities regulations. In the first enforcement action regarding Regulation FD since 2013, the SEC charged TherapeuticsMD Inc., a...more

Mayer Brown Free Writings + Perspectives

SEC Brings Regulation FD Action

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

Herbert Smith Freehills Kramer

SEC Brings Enforcement Action against TherapeuticsMD for Violations of Regulation FD

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

Bass, Berry & Sims PLC

Recent SEC Enforcement Action Drives Home the Importance of Regulation FD Policies and Training

Bass, Berry & Sims PLC on

On August 20th, 2019, 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...more

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