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
The government has published its response to the consultation on the exhaustion regime for IP rights. The overall conclusion is that the UK will permanently maintain its UK+ IP exhaustion regime, the bespoke (and...more
Pharmaceutical companies promoting prescription-only medicines to health professionals and other relevant decision makers in the UK must now adhere to revised industry standards that came into operation from 1 October 2024...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
On 12 October 2023, the Medicines and Healthcare products Regulatory Agency (the MHRA) announced that the healthcare and life sciences sector will benefit from a new streamlined notification scheme for lowest-risk clinical...more
Earlier this year, the UK’s medicines regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), announced that a new International Recognition Procedure (IRP) will be put in place for the approval of new...more
STADA and Xbrane Announce Approval of Ranibizumab Biosimilar in UK - On January 16, 2023, STADA Arzneimittel AG (STADA) and Xbrane Biopharyma AB (Xbrane) announced that the UK’s Medicines and Healthcare product Regulatory...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
Following approval by the European Commission in July, last week Accord Healthcare announced the launch of Zercepac® a biosimilar to Herceptin® in the United Kingdom....more
On 30 January 2020, the Court of Justice of the European Union (CJEU) issued its decision on a request for preliminary ruling submitted by the UK Competition Appeal Tribunal (CAT) in a case concerning the long-standing...more
Multiple sources are reporting that Celltrion is planning to roll out REMSIMA SC, its subcutaneous infliximab biosimilar of Johnson & Johnson’s autoimmune disease treatment REMICADE, in Europe in the first quarter of 2020,...more
A last-minute deal between defendants McKesson, Cardinal Health, AmerisourceBergen, and Teva and plaintiffs’ attorneys means that multidistrict opioid epidemic litigation set to kick off in Ohio federal court today will not...more
A group of three major drug distributors—McKesson, AmerisourceBergen, and Cardinal Health—are in the midst of talks with representatives of state and local governments who have brought more than 2000 opioid-related lawsuits...more
With the possibility of the UK leaving the EU on 29 March 2019 (a "no deal" Brexit) still on the table, life sciences companies are continuing their "no deal" preparations....more
Do you have a centralised EU marketing authorisation holder, orphan designation holder, manufacturing activities including import, batch control or batch release sites, a Qualified Person for Pharmacovigilance (QPPV),...more
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has issued updated guidance on how the UK would regulate medicines, medical devices and clinical trials in the event that the UK leaves the EU on 29 March 2019...more
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has initiated a consultation on the legislation and regulatory processes for medicines, medical devices and related clinical trials that would need to be...more
Read the latest news on antitrust, competition, and economic regulation in this summer edition of our quarterly ACER newsletter. ...more
On 23 August 2018, the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA), the network of the National Competent Authorities in the European Economic Area (EEA), published the work programme of their...more
On 19 June 2018, the European Medicines Agency (EMA) published updates to its Brexit Q&A document for human and veterinary medicines authorised via the centralised procedure and to its practical procedural guidance on making...more
The Business, Energy and Industrial Strategy Committee, a parliamentary select committee, has published a report on the consequences of Brexit on the UK pharmaceutical industry. ...more
The European Commission (EC) and other national competition authorities (NCAs) have traditionally shied away from investigating allegations of excessive pricing and appearing as price regulators. Commissioner Vestager warned...more
In its decision of July 12, 2017 in Actavis v. Eli Lilly, the Supreme Court of the United Kingdom for the first time formally adopted the concept of a doctrine of equivalents when considering what constituted an infringement...more
Last week it was reported (here and here) that Merck launched Samsung Bioepis’ Ontruzant® in the United Kingdom, the first biosimilar trastuzumab launched in Europe. Ontruzant® is a biosimilar of Roche’s Herceptin® and is...more