As we reflect on 2023 and make predictions for 2024, it is remarkable the number of significant events occurring this past year that will be impactful for the activities of the life sciences industry going forward. Although...more
1/26/2024
/ Acquisitions ,
Amgen v Sanofi ,
Antitrust Division ,
Artificial Intelligence ,
Biden Administration ,
Biosimilars ,
Chevron Deference ,
Clawbacks ,
Clinical Trials ,
Compensation ,
Compliance ,
Corporate Integrity Agreement ,
Criminal Prosecution ,
Data Preservation ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Drug Pricing ,
Enforcement ,
EU ,
Executive Orders ,
False Claims Act (FCA) ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Investigations ,
Life Sciences ,
Mergers ,
Mobile Devices ,
OPDP ,
Pharmaceutical Industry ,
Pilot Programs ,
Privacy Laws ,
Proposed Rules ,
Risk Management ,
Section 340B ,
Self-Disclosure Requirements ,
Voluntary Disclosure
Pharma and Life Sciences Investigations and Prosecutions: The First Two Years of the Biden Administration -
With the two-year mark of the Biden presidency looming, the administration’s approach to prosecuting and...more
1/12/2023
/ Biden Administration ,
Centers for Medicare & Medicaid Services (CMS) ,
Corporate Governance ,
Criminal Prosecution ,
Digital Health ,
Enforcement ,
False Claims Act (FCA) ,
Life Sciences ,
Medicare Advantage ,
OPDP ,
Pharmaceutical Industry ,
Privacy Laws ,
Stocks ,
Telehealth
On March 21, 2022, the U.S. Securities and Exchange Commission (the “SEC”) published the proposed rule entitled the “Enhancement and Standardization of Climate-Related Disclosures” that would require registered public...more
On February 10, 2022, the U.S. Securities and Exchange Commission (the “SEC”) proposed amendments to accelerate the filing deadlines for Schedule 13D and Schedule 13G beneficial ownership reports, expand beneficial ownership...more
In High River Limited Partnership v. Occidental Petroleum Corp., C.A. No. 2019-0403-JRS, 2019 WL 6040285 (Del. Ch. Nov. 14, 2019) (Slights, V.C.), the Delaware Court of Chancery held that a stockholder’s mere disagreement...more
On August 8, 2019, the Securities and Exchange Commission (the “SEC”) announced that it voted to propose rule amendments to modernize the description of business, legal proceedings, and risk factor disclosures that public...more
9/19/2019
/ Comment Period ,
Disclosure Requirements ,
Form 10-K ,
Modernization ,
Proposed Amendments ,
Proposed Rules ,
Regulation S-K ,
Risk Factors ,
Securities Act of 1933 ,
Securities and Exchange Commission (SEC) ,
Securities Exchange Act
On February 6, 2019, the Securities and Exchange Commission released two Compliance and Disclosure Interpretations (CDIs) discussing disclosure requirements in instances where a director or board nominee self-identifies...more
2/12/2019
/ Board of Directors ,
C&DIs ,
Director Nominations ,
Disclosure Requirements ,
Diversity ,
New Guidance ,
Proxy Statements ,
Publicly-Traded Companies ,
Regulation S-K ,
Securities and Exchange Commission (SEC) ,
Self-Identification
Public reporting companies that have material weaknesses in their internal control over financial reporting (“ICFR”) are required under Rule 308 of the Securities Exchange Act of 1934, as amended, to report such material...more
2/6/2019
/ Audit Reports ,
Audits ,
Corporate Governance ,
Disclosure Requirements ,
Enforcement Actions ,
Financial Statements ,
ICFR ,
Internal Audit Functions ,
Material Misstatements ,
Proxy Statements ,
Securities and Exchange Commission (SEC)
UPDATE: On August 5, 2020, the Delaware Supreme Court summarily affirmed the judgment of the Court of Chancery “on the basis of and for the reasons stated in its January 25, 2019 opinion.”
Section 220 of the Delaware...more
2/1/2019
/ Books & Records ,
Burden of Production ,
Delaware General Corporation Law ,
Electronic Communications ,
Electronically Stored Information ,
Email ,
Investigations ,
Recordkeeping Requirements ,
Section 220 Request ,
Shareholder Litigation ,
Shareholders
On May 24, 2018, President Donald J. Trump signed into law the Economic Growth, Regulatory Relief, and Consumer Protection Act (the “Act”). The Act, which primarily focuses on rolling back certain regulatory provisions of the...more
6/20/2018
/ Dodd-Frank ,
Economic Growth Regulatory Relief and Consumer Protection Act ,
Financial Institutions ,
Financial Regulatory Reform ,
Investors ,
New Legislation ,
Private Placements ,
Reporting Requirements ,
Rule 506 Offerings ,
Securities and Exchange Commission (SEC) ,
Securities Exchange Act ,
Tier 2 Offerings ,
Trump Administration
On October 23, 2017, the Securities and Exchange Commission approved the Public Company Accounting Oversight Board’s (“PCAOB”) proposal to adopt a new auditing standard, AS 3101....more