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Securities and Exchange Commission (SEC) Enforcement Actions Food and Drug Administration (FDA)

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

Morgan Lewis - As Prescribed

Clinicaltrials.gov: Recent Action May Signal Increased Attention from FDA on Trial Data Reporting Compliance

The US Food and Drug Administration (FDA) recently issued a notice of noncompliance to the FADOI Foundation, citing the organization’s failure to submit required clinical trial results to ClinicalTrials.gov. The notice...more

Cooley LLP

SEC charges Becton Dickinson with misleading investors about regulatory risks and product sales

Cooley LLP on

The SEC has announced settled charges against Becton, Dickinson and Company, a medical device manufacturer known as BD listed on the NYSE, for “repeatedly misleading investors about risks associated with its continued sales...more

Stinson LLP

Trump's First 100 Days: Business Litigation

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Banks and other regulated entities have frequently challenged Biden-era rulemakings in court. The incoming administration may change the trajectory of these cases, as Trump has promised to stop agency overreach....more

DLA Piper

Food and Beverage News and Trends - September 2024 #2

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This regular publication by DLA Piper lawyers focuses on helping clients navigate the ever-changing business, legal, and regulatory landscape....more

Beveridge & Diamond PC

Has the major questions doctrine had a major impact?

Since its formal announcement as a constitutional “doctrine” in West Virginia v. EPA, administrative and environmental law practitioners have speculated that the major questions doctrine (MQD) would mark a major shift in how...more

Morrison & Foerster LLP

2024 Regulatory, Compliance, and Enforcement Predictions for Life Sciences Companies

The year 2023 was a busy one for regulatory, compliance, and enforcement developments in the healthcare and life sciences industries, and 2024 promises to be even busier. We tapped MoFo’s Life Sciences + Healthcare Compliance...more

Foley & Lardner LLP

Reading the Leaves: What's in Store for Cannabis in 2021

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On the heels of a year beset by turmoil and the myriad challenges caused by the global pandemic, the cannabis industry nevertheless entered 2021 poised for significant growth amid a landscape teeming with opportunity. Public...more

Vinson & Elkins LLP

DOJ And SEC Divide And Conquer To Police Coronavirus-Related Securities Fraud

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In early June, federal agencies brought some of the first enforcement actions against COVID-19 securities fraudsters, involving over $100 million in fraudulent claims and profits, making good on their promise to investigate...more

A&O Shearman

Northern District Of Illinois Sustains But Pares Putative Class Actions Against Pharmaceutical Company

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On February 5, 2020, Judge Matthew F. Kennelly of the United States District Court for the Northern District of Illinois sustained some but not all claims in a putative class action asserting violations of Sections 10(b) and...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

Foley & Lardner LLP

Selective Disclosure Violation Results in SEC Order

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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

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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

Fenwick & West LLP

SEC Fines Life Sciences Company for Regulation FD Violations

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For the first time in six years, the U.S. Securities and Exchange Commission issued an enforcement action against a company solely for Regulation FD violations. On Aug. 20, the SEC announced that it charged life sciences...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

Ballard Spahr LLP

SEC Signals New Phase of Regulation FD Enforcement

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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

Stinson - Corporate & Securities Law Blog

SEC Charges Issuer for Reg FD Violation for Selective Disclosure to Analysts

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

Skadden, Arps, Slate, Meagher & Flom LLP

A Dialogue With Corporate Counsel: Skadden’s Eighth Annual Pharmaceutical and Medical Device Seminar

On October 30, 2018, Skadden hosted its Eighth Annual Pharmaceutical and Medical Device Enforcement and Litigation Seminar in New York City, which focused on U.S. enforcement issues faced by companies throughout the industry....more

Akin Gump Strauss Hauer & Feld LLP

Red Notice Newsletter - Russian

ANTICORRUPTION DEVELOPMENTS – Canadian Mining Company Settles with SEC over FCPA Charges – On March 26, Kinross Gold Corporation settled with the Securities and Exchange Commission (SEC) over its alleged failure to...more

Akin Gump Strauss Hauer & Feld LLP

Red Notice Newsletter - Chinese

ANTICORRUPTION DEVELOPMENTS – Canadian Mining Company Settles with SEC over FCPA Charges – On March 26, Kinross Gold Corporation settled with the Securities and Exchange Commission (SEC) over its alleged failure to...more

Akin Gump Strauss Hauer & Feld LLP

Red Notice Newsletter - March 2018

ANTICORRUPTION DEVELOPMENTS – Canadian Mining Company Settles with SEC over FCPA Charges – On March 26, Kinross Gold Corporation settled with the Securities and Exchange Commission (SEC) over its alleged failure to...more

Holland & Knight LLP

Holland & Knight's Israel Practice Newsletter - Winter 2017

Holland & Knight LLP on

Holland & Knight invites you to read our Winter 2017 Israel Practice newsletter, in which our authors discuss pertinent American-Israeli topics. As Israel has been a crossroads and a prolific source of new ideas for more than...more

Skadden, Arps, Slate, Meagher & Flom LLP

A Dialogue With Corporate Counsel: Skadden’s Seventh Annual Pharmaceutical and Medical Device Seminar

Panelists examined major enforcement actions from 2017 and identified key trends. Aggressive Enforcement With a Decrease in High-Dollar Settlements. Panelists noted that the Department of Justice (DOJ) continues its...more

BakerHostetler

2016 Mid-Year Securities Litigation and Enforcement Highlights

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Welcome to the 2016 Mid-Year Report From the BakerHostetler Securities Litigation and Regulatory Enforcement Practice Team. The purpose is to provide a periodic survey, apart from our team Executive Alerts, on matters...more

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