Data Driven Compliance: The Failure to Prevent Fraud Offense: Insights for US General Counsels with Mike DeBernardis
Daily Compliance News: August 20, 2025, The Boss is Back Edition
The LathamTECH Podcast — Turning a London Eye Toward International Tech Growth
AI Today in 5: August 8, 2025, The Don’t Wait Episode
Data Driven Compliance: Understanding the ECCTA and Its Impact with Jonathan Armstrong
Compliance Tip of the Day: M&A – International Issues
From the Editor’s Desk: Compliance Week’s Insights and Reflections from July to August 2025
Data Driven Compliance: Understanding the ECCTA and Its Impact on Fraud Prevention with Vince Walden
Everything Compliance: Episode 158, The No to Corruption in Ukraine Edition
Data Driven Compliance: Understanding the UK’s New Failure to Prevent Fraud Offense with Sam Tate
Daily Compliance News: July 25, 2025, The New Sheriff in Town Edition
Everything Compliance: Episode 157, The Q2 2025 Great Women in Compliance Edition
The Capital Ratio Podcast | Entering the US Banking Market
Great Women in Compliance: GWIC X EC Q2 2025 - Exploring Compliance Innovations
An Ounce of Prevention Podcast | The International Anti-Corruption Prosecutorial Taskforce and the Future of Global Enforcement
The LathamTECH Podcast — Where Digital Assets Slot Into a Shifting Fintech Regulatory Landscape: Insights From the US, UK, and EU
10 For 10: Top Compliance Stories For the Week Ending May 24, 2025
Daily Compliance News: May 23, 2025, The Gutless Wonders Edition
Daily Compliance News: May 21, 2025, The I Want You Back Edition
Everything Compliance: Episode 153, The CW 25 Edition
As the life sciences, medtech, and diagnostic industries continue to grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving and emerging...more
On June 25, 2025, Kashiv BioSciences announced positive topline results from its confirmatory Phase 3 trial of ADL-018, a proposed biosimilar to XOLAIR® (omalizumab), in patients with chronic spontaneous urticaria. ...more
On February 5, 2025 Valneva SE (“Valneva”) announced that the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) granted marketing authorization for Valneva’s chikungunya vaccine, IXCHIQ. ...more
In the EU, the AI Act has been approved, carrying significant implications for medical device, technology, and pharmaceutical firms. In the US, there is no comprehensive federal AI legislation, but at least 45 states have...more
Welcome to the Akin Intelligence September-October recap. Around the one-year anniversary of the AI Executive Order, the White House announced that agencies had carried out their directives. Members of Congress introduced a...more
As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape....more
Welcome to the April-May edition of Akin Intelligence. This edition is a double header, covering both months as we prepare for the launch of our new AI Hub—a one-stop resource for AI coverage that will launch soon. Starting...more
Device manufacturers may soon have access to a new framework for marketing and selling medical devices in the United Kingdom. On May 21, 2024, the UK Medicines and Healthcare products Regulatory Agency (MHRA) published...more
As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more
Earlier today, UK’s Medicines and Healthcare products Regulatory Agency (MHRA) granted conditional marketing authorization to Vertex Pharmaceuticals and CRISPR Therapeutics for their CRISPR/Cas9 gene therapy, CASGEVY...more
Four months after completing its first premarket consultation, the Food and Drug Administration (FDA) cleared its second premarket consultation for cell-cultivated meat production. We wrote about the first premarket...more
Companies are developing, deploying, and interacting with artificial intelligence (AI) technologies more than ever. At Goodwin, we are keeping a close eye on any regulations that may affect companies operating in this...more
Introducing Our Secret Plan to Fight Inflation - It’s simple: Don’t fall afoul of the FTC - ’Twas Ever Thus - Every year, like the swallows returning to Capistrano, the Perseid meteor shower, or a Real Housewives...more
Kevin DeJong (Senior Editor) and Shweta Kumar (Editor) from the Big Molecule Watch recently interviewed Rachel Goode, Ph.D. to discuss an article she recently co-authored, “Biological patent thickets and delayed access to...more
On November 17, 2022, Senator Mike Lee (R-UT) introduced the “Biosimilar Red Tape Elimination Act” to increase biosimilar competition and reduce patient costs by prohibiting the FDA from requiring switching studies to approve...more
As the European Union (“EU”) continues to debate whether downstream responsibilities will fall within the contours of its hefty Corporate Sustainability Mandatory Due Diligence Directive (“CSMDD”), and the EU Council just...more
Even as the coronavirus batters parts of the country, notably the Mountain West, public health officials are pointing to key ways in which Americans could safely and effectively further quell the pandemic that has claimed...more
This week the U.S. Food and Drug Administration (FDA), along with Health Canada and the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA), identified 10 guiding principles to inform the development...more
On October 27, 2021, pursuant to the Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device Action Plan (Action Plan), the US Food and Drug Administration (FDA) released its Good Machine Learning...more
In Washington: The U.S. surpassed 500,000 deaths from COVID-19 on Monday, in a pandemic that has lasted almost a year. The nation’s total virus toll is higher than in any other country globally, and it means that more...more
Games vary in difficulty from the first levels of Candy Crush to the final bosses of Sekiro: Shadows Die Twice. They vary in visual fidelity from the ASCII characters of Dwarf Fortress to the high-detail, motion-capture shown...more
On December 2, 2020, the U.K. became the first Western nation to approve the use of Pfizer/BioNTech’s COVID-19 (SARS-CoV-2) vaccine for mass inoculation. As pressure mounts on U.S. regulators to follow suit, the next 30 days...more
Brexit Effects on Trademarks Beginning January 1 - Trademark owners with registrations in EU where the UK is designated should soon receive notification for treatment of registrations and applications following the Brexit...more