News & Analysis as of

Pharmaceutical Industry › Food and Drug Administration (FDA) › Corporate Governance

A&O Shearman

Western District Of Pennsylvania Denies Motion For Judgment On The Pleadings In Securities Class Action Against Pharmaceutical...

A&O Shearman on

On July 8, 2025, Judge Nicholas Ranjan of the United States District Court for the Western District of Pennsylvania denied a motion for judgment on the pleadings, allowing a putative securities class action to proceed against...more

Paul Hastings LLP

Biotech Spin-Off Transactions

Paul Hastings LLP on

As we previously discussed (here and here), the biotech mergers and acquisitions market currently faces significant headwinds. These challenges include frozen capital markets, regulatory uncertainty at the Food and Drug...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

Fenwick & West LLP

Clinical Data FAQs: How to Prepare for Disclosure

Fenwick & West LLP on

When it comes to disclosing clinical trial data in the biotechnology arena, in particular for public biotech companies, timing is everything. Disclosures are not just about when to reveal the information, but also what is...more

Orrick, Herrington & Sutcliffe LLP

Board Oversight of Clinical Trials During the Pendency of the COVID-19 Pandemic

Orrick, Herrington & Sutcliffe LLP on

COVID-19 has had far-reaching social, economic and regulatory impacts. Nearly all companies (private and public, large and small) have had reason to more frequently convene their boards of directors to review and monitor...more

Orrick, Herrington & Sutcliffe LLP

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

Orrick, Herrington & Sutcliffe LLP on

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

WilmerHale

Another Reminder from Delaware About the Duty of Oversight

WilmerHale on

Following this summer’s much publicized decision by the Delaware Supreme Court in the Marchand v. Barnhill (Blue Bell Creameries) case, the Delaware Court of Chancery’s holding in In re Clovis Oncology, Inc. Derivative...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

The Volkov Law Group

Delaware Court Increases Scrutiny of Corporate Board Oversight and Monitoring of Compliance Programs

The Volkov Law Group on

On October 1, 2019, in In re Clovis Oncology, Inc. Derivative Litigation, a Delaware Chancery Court denied a motion to dismiss the plaintiffs’ claims under the Caremark decision against individual directors for failing to...more

9 Results
 / 
View per page
Page: of 1

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
Sign up Log in
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide