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Enforcement Actions › Securities Regulation › Pharmaceutical Industry

McDermott Will & Schulte

New SEC Leadership Signals Continued Focus on FDA-Related Disclosures

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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

Quarles & Brady LLP

“It’s Okay, These Products Aren’t Paid for by Medicare” – Think Again

Quarles & Brady LLP on

A recent Securities and Exchange Commission (“SEC”) settlement with DMK Pharmaceuticals Corporation (“DMK Pharmaceuticals”) and its Chief Financial Officer (“CFO”) serves as a good reminder that SEC-regulated entities...more

Cooley LLP

Complete Response Letter, Warning Letter and Shareholder Lawsuit Follow FDA Data Integrity Findings

Cooley LLP on

Applied Therapeutics, a clinical-stage biopharmaceutical company, is under heightened scrutiny following the issuance of a November 2024 Warning Letter from the US Food and Drug Administration (FDA) on the heels of a routine...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

Stinson - Corporate & Securities Law Blog

SEC Brings Enforcement Action for Loss Contingency Disclosure

Stinson - Corporate & Securities Law Blog on

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

Mayer Brown Free Writings + Perspectives

SEC Brings Regulation FD Action

Mayer Brown Free Writings + Perspectives on

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

Herbert Smith Freehills Kramer on

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

Ballard Spahr LLP

SEC Signals New Phase of Regulation FD Enforcement

Ballard Spahr LLP on

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

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