AI Washing: Simple Guidance to Avoid Risk
Tech Debt is Common. What does it mean for IPO readiness from a cybersecurity perspective?
Episode 332 -- Deep Dive into SEC’s Internal Controls and Cybersecurity Settlement with R&R Donnelly
Mitigating Political-Law Risk
The Preferred Return Podcast | AIFMD II – Implementation Begins
Why ESG Matters?
Meeting the Proposed SEC Climate Disclosure Requirements
California Regulation of Charitable Fundraising Platforms Part 2 - Reporting Due Diligence, Recordkeeping, and Disclosure Rules
ESG Masterclass — ESG and Impact Investing
The Justice Insiders Podcast - Human Beings: Cybersecurity's Most Fragile Attack Surface
JONES DAY TALKS®: Court Grants Stay on SEC’s Climate Disclosure Rule, but Companies Should Continue Preparations
ESG Masterclass — ESG and Politics
Ad Law Tool Kit Show – Episode 5 – Surviving an FTC Investigation
SEC’s New Cyber Rules for Publicly Traded Companies — The Consumer Finance Podcast
PLI's inSecurities Podcast - Commissioner Uyeda on “the Perils of Regulation by Theory and Hypothesis”
PLI's inSecurities Podcast - Addressing the “Netflix Problem” in Securities Regulation
What Nonprofit Leaders Need To Know About the Corporate Transparency Act
December 1st Deadline to Adopt Executive Compensation Clawback Policies — The Consumer Finance Podcast
How to Fix the Cyber Incident Reporting Mess--DHS Weighs In
ESG Essentials: What You Need To Know Now - Episode 16 - ESG Backlash
On the heels of a $7.6 million payment by Cleveland Clinic to settle allegations of False Claims Act (FCA) violations and unallowable sharing of passwords, Michael Lauer, NIH deputy director for extramural research, penned a...more
Although the rise of artificial intelligence (AI) has created many opportunities and breakthroughs for life sciences companies in preclinical and clinical development, risks associated with the use of AI cannot be ignored....more
Morrison Foerster Investigations + White Collar Defense partner Nate Mendell, former Acting U.S. Attorney for the District of Massachusetts, hosted the fifth episode of When Your Life Sciences Are on the Line, where leading...more
Report on Research Compliance 21, no. 9 (September, 2024) - Based on their review of public data on ClinicalTrials.gov, a bipartisan quartet of U.S. representatives has asked the Food and Drug Administration (FDA) to...more
In an encouraging sign that the equity capital markets may be improving for biotechnology companies, Bicara Therapeutics Inc. and Zenas Biopharma, Inc. filed S-1 registration statements yesterday, signaling their intention to...more
In the quest for a sustainable future, the United Nations’ Sustainable Development Goals (SDGs) represent goalposts, albeit lofty ones, that countries can aim for. These 17 interconnected goals address pressing global...more
Based on client inquiries and FDA actions, the Food and Drug Administration is focusing more on companies not submitting data to www.ClinicalTrials.gov. It is taking stronger action against those companies it believes are...more
There have been 44 initial public offerings (IPOs) listed on the US stock markets in 2024 thus far, many of which continue to trade at a premium to their initial offering price, demonstrating the strength and buoyancy of...more
Amidst challenges and conflicting demands from a variety of stakeholders, technology and life sciences companies have increased their voluntary disclosure regarding environmental, social and governance (ESG) concerns. Despite...more
HHS Cybersecurity Performance Goals and the Healthcare Industry - The healthcare industry is a major target for cyberattacks because of all of the personal information collected from patients. Recognizing that the healthcare...more
On February 7, 2024, the Federal Court dismissed Takeda’s action under subsection 6(1) of the Patented Medicines (Notice of Compliance) Regulations in relation to dexlansoprazole (Takeda’s DEXILANT). Justice Furlanetto...more
The oversight obligations of boards continue to expand. Recent enforcement actions and new laws in areas such as cybersecurity, artificial intelligence and supply chains create new challenges for boards, as we explain in this...more
Why is everyone talking about provider disclosures to law enforcement of late? The Senate Finance Committee authored a letter to Xavier Becerra, Secretary of the U.S. Department of Health and Human Services (HHS), outlining...more
An increasing number of states are requiring advance notice of health care transactions. These requirements may delay transactions or result in confidential information becoming accessible to the public. Effective August 1,...more
Following the IRS’s issuance of guidance in Notice 2023-63 regarding R&D capitalization under Section 174, a working group of several Fenwick tax group attorneys commented to the IRS and the U.S. Treasury Department on...more
On 26 June 2023, the International Sustainability Standards Board (“ISSB”) issued its first two sustainability standards, IFRS S1 and IFRS S2. These standards, which incorporate the recommendations of the Task Force on...more
Artificial intelligence promises to transform the way we live and work and its impact will undoubtedly stretch to every business sector across the globe. This next generation of technology brings exciting possibilities and...more
Some chemical innovators have found the recent Supreme Court decision in Amgen v. Sanofi to suggest that chemical inventions will be subject to new and draconian disclosure standards going forward. A few have even suggested...more
New York recently enacted new legislation that will amend Article 45-A of the New York Public Health Law, entitled “Disclosure of Material Transactions”. Although the legislation, as enacted, contains no description of...more
The fourth beta version establishes draft disclosure metrics as well as biome and sector guidance — with final TNFD recommendations due in September 2023. The Taskforce on Nature-Related Financial Disclosures (TNFD)...more
Environmental, social and governance (ESG) concerns and how companies respond to them continue to generate scrutiny from a large number of stakeholders. Last year, in our ESG in Silicon Valley: A Look at the ESG Disclosure...more
Amazon Sued for Not Telling New York Store Customers about Tracking Biometrics - “Thanks to a 2021 law, New York is the only major American city to require businesses to post signs letting customers know they’re tracking...more
For companies of all industries, ESG matters have become an area of intense focus. In addition to investor and activist pressure, the growth of ESG ratings – and proposed climate and broader ESG disclosure requirements in the...more
From 2004 to 2014, clinical trials in the EU and countries in the European Economic Area (collectively known as EU/EEA Countries) were subject to the EU Clinical Trial Directive 2001/20/EC (CTD) which set rules for conducting...more
Corporate social responsibility is not a new concept, but in recent years there has been an increased focus by investors and other stakeholders regarding how companies are addressing their environmental, social and governance...more