News & Analysis as of August 19, 2025

Pharmaceutical Industry

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A repository for the most well-read content on JD Supra at any given time, along with occasional roundups of popular content by specific topic. Also stop by for monthly recaps of hot articles for the previous... more +

Update on biosimilars in Canada – June 2025

Smart & Biggar on 6/25/2025

This article provides an update on developments in the biosimilar space in Canada—regulatory, approvals, pending submissions, litigation, and market access—since our March 2024 update. Consultation on revised biosimilar...more

What Life Sciences Companies Need to Know in 2025

ArentFox Schiff on 4/29/2025

Key Insights for Pharma Manufacturers Regarding the AKS - In a series of recent legal challenges initiated by the pharmaceutical industry against the US Department of Health and Human Services Office of the Inspector General...more

China Formalizes Regulatory Data Protection Mechanism

Ropes & Gray LLP on 4/1/2025

Recently, the National Medical Products Administration (NMPA) issued the draft version of 'Implementation Measures for Drug Trial Data Protection (hereinafter referred to as the 'Draft for Comments'), aiming to clarify the...more

Regulatory Updates on Samsung’s Denosumab Biosimilars

Goodwin on 2/18/2025

On February 13, 2025, the FDA approved Samsung Bioepis Co., Ltd.’s denosumab biosimilars, OSPOMYV™ (denosumab-dssb; 60 mg pre-filled syringe) and XBRYK™ (denosumab-dssb; 120 mg vial), referencing Amgen’s PROLIA® and XGEVA®,...more

The EU Medical Device Regulation: What’s Next?

McDermott Will & Schulte on 2/3/2020

The EU Medical Device Regulation goes into application on 26 May 2020, with the In Vitro Diagnostic Medical Device Regulation set to follow on 26 May 2022. These new Regulations bring sweeping changes to the market clearance...more

MoFo IP Newsletter - November 2016

Morrison & Foerster LLP on 11/29/2016

FDA (Finally!) Issues New Regulations to Clarify Pharmaceutical Patent Litigation: How to Use Patent “Use Codes” - October 6, 2016, the FDA issued a final rule implementing certain provisions of the Medicare...more

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