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
10 For 10: Top Compliance Stories For the Week Ending, May 3, 2025
Daily Compliance News: April 30, 2025, The 4 AM Wake-Up Call Edition
The Capital Ratio Podcast | Stablecoins: Regulatory Issues for UK and EU Banks To Consider
An Ounce of Prevention Podcast | Preparing for the UK Failure to Prevent Fraud Offence
Compliance into the Weeds: Global Anti-Corruption Leadership
Daily Compliance News: March 24, 2025, The ABC Task Force Edition
Daily Compliance News: March 18, 2025, The Slack Channel Edition
Podcast — UK FinReg Focus Areas in 2025: Retail Markets
Podcast — UK FinReg Focus Areas in 2025: Wholesale Markets
Fintech Focus Podcast | Navigating IT and Security Risks in Fintechs in Light of Impending DORA Deadline
The Standard Formula Podcast | The SFCR and Other Public Reporting: A Solvency II Cornerstone
Fintech Focus Podcast | Sanctions Compliance: Regulators Set Their Sights on Fintechs
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
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
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
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
On November 7, 2022, the UK’s Medicines and Healthcare Products Regulatory Agency (“MHRA”) updated its “Guidance on the licensing of biosimilar products” by expanding the criteria for achieving interchangeability between a...more
Earlier this week, Teva Pharmaceutical Industries Ltd. (Teva) announced that the UK Medicines & Healthcare Regulatory Agency (MHRA) approved ONGAVIA, a ranibizumab biosimilar referencing Genentech’s LUCENTIS. Ranibizumab...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
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
On 1 March 2019, the President of the Polish Office for Registration of Medicinal Products, Medical Devices and Biocidal Products issued yet another communique concerning consequences of Brexit, this time with respect to the...more
The President of the Office for the Registration of Medicinal Products, Medical Devices, and Biocidal Products (URPL) estimates that approximately 20% of all the 10,000 medicinal products registered in Poland will be affected...more
Amgen has announced that its adalimumab biosimilar AMGEVITA launched yesterday in European markets. This is Amgen’s first “inflammation” biosimilar to launch in Europe, and its second biosimilar to launch in Europe overall. ...more
The United Kingdom’s National Health Service (NHS) recently announced that in its last fiscal year, it had saved $419 million in switching to biosimilar and generic versions of ten expensive drugs. These savings exceeded the...more
The UK House of Commons Health and Social Care Committee has published the findings of its six-month long investigation into the impact of Brexit on medicines, medical devices and substances of human origin. ...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
The UK government has published a White Paper setting out its new Industrial Strategy and, as part of that strategy, has agreed a Sector Deal with the UK life sciences sector. ...more
Last week, a staff retention survey was published, according to which certain contestants in the race for hosting the EMA were less liked by the EMA staff. And now the decision-making progress is going forward....more
The Competition and Markets Authority (CMA) in the United Kingdom announced a provisional decision finding that Merck Sharp & Dohme (MSD) violated competition law with its discount pricing on Remicade. This provisional...more
According to Business Wire, on September 12, 2016, Samsung Bioepis announced that it has added Canada to its growing list of jurisdictions in which it has received regulatory approval for its biosimilar of Amgen’s Enbrel®...more
The United Kingdom’s referendum in favor of withdrawal from the European Union, colloquially known as “Brexit,” has already sent shockwaves through the business world, both within the UK, and abroad. The impact of Brexit on...more