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Dacheng

SAMR Publishes Official Review on China’s Antitrust Enforcement in 2024: Key Developments and Takeaways

Dacheng on

On June 7, 2025, China’s State Administration for Market Regulation (SAMR) released the 2024 Annual Report on Antitrust Enforcement (“Report”), providing a comprehensive overview of key legislative developments, enforcement...more

A&O Shearman

Clinical Trial Regulation: A streamlined reform of the UK Clinical Trials Regulatory Framework - new measures published

A&O Shearman on

The MHRA announced on Tuesday the biggest overhaul of clinical trial regulation in the UK in 20 years. The details of the amendments to clinical trial regulation are set out in the MHRA’s response to a public consultation...more

Sheppard Mullin Richter & Hampton LLP

CMS Releases Guidance on Implementation of Rebate Programs for Certain Medicare Part B and Part D Drugs

On February 9, 2023, the Centers for Medicare and Medicaid Services (“CMS”) released two highly-anticipated guidance documents (the “Guidance”) detailing the agency’s proposed implementation of the Medicare Part B (“Part B”)...more

Fish & Richardson

Biosimilars 2021 Year in Review

Fish & Richardson on

2021 saw several important milestones in the biosimilars space, including the much anticipated first interchangeable designations by FDA and the approval of the first ophthalmology biosimilar. The biosimilar market also...more

Sheppard Mullin Richter & Hampton LLP

Federal Government Announces Enforcement Discretion, Deferral For Certain Price Disclosures And Future Rulemakings

Health plans and issuers racing to implement overlapping price transparency and disclosure requirements in response to the Transparency in Coverage final rule (TiC Final Rule) and the Consolidated Appropriations Act, 2021...more

Latham & Watkins LLP

MHRA Releases No-Deal Brexit Guidance for Life Sciences Companies

Latham & Watkins LLP on

The guidance provides helpful clarity on key regulatory changes impacting life sciences companies in the event of a no-deal Brexit. The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published a...more

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