News & Analysis as of

Corporate Governance Clinical Trials

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 Approach Fundraising and Investor Relations

Fenwick & West LLP on

For publicly traded biotech companies, disclosing clinical trial data can be an exciting milestone as you build towards an exit or public offering—but disclosure is a double-edged sword....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

Foley & Lardner LLP

Artificial Intelligence: Is the Health Care Sector Ready for the Rollout?

Foley & Lardner LLP on

On July 17, 2024, Foley & Lardner LLP hosted the Boston Health Care AI & Technology Investor Summit with Endeavor Venture Funds, bringing together hundreds of attendees in person and virtually to discuss issues surrounding...more

Orrick, Herrington & Sutcliffe LLP

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

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

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

Snell & Wilmer

Delaware Court of Chancery Permits Caremark Claim Alleging Directors’ Failure to Monitor Critical Company Business Operations

Snell & Wilmer on

On October 1, 2019, the Delaware Court of Chancery issued its decision in In re Clovis Oncology, Inc. Derivative Litigation, C.A. No. 2017-0222-JRS (Del. Ch. Oct. 1, 2019), which addresses the duties of directors to oversee...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

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

A Director’s Mission: Understanding, Monitoring and Accurately Reporting Mission Critical Operations

On October 1, 2019, the Court of Chancery rendered an opinion in In re Clovis Oncology, Inc. Derivative Litigation, denying a motion to dismiss a Caremark claim for breach of fiduciary duty and reinforcing a director’s duty...more

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