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Understanding Recent Changes to 505(b)(2) Drugs and Reimbursement

Pharmacy Times

This pathway’s expanded use and shifting Centers for Medicare & Medicaid Services (CMS) policies are reshaping reimbursement practices and therapeutic equivalence standards for 505(b)(2) drugs. It is basically an essential copy, and the pharmaceutical manufacturer has to show bioequivalence to the reference product,” Soefje said.

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Pharmacy Policy Updates for June 2025

Pharmacy Times

According to Trump, patients could see cost reductions of 30% to 80%, but experts question the feasibility and practicality of implementing such a policy within the complex United States drug pricing and supply system. Kennedy Jr, is permitted to develop a new rule that ties American drug prices to those of other nations.

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Building Intelligent Pharma Supply Chain Management with Real-World Data

Pharmaceutical Commerce

This includes requirements for drug data storage and the maintenance of interoperable systems for sharing data, along with requirements for the data that must be stored on treatment labels. Together, these requirements create a foundation of RWD that stakeholders can leverage to improve supply chain operations and safety.

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US trade tariffs and the potential impact on pharma supply chains

Pharmaceutical Technology

Miranda McLaren June 30, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook When Donald Trump was elected the 47 th president of the United States of America, the outlook for pharmaceuticals was unclear, with 55% of North American industry professionals expecting negative repercussions when surveyed by GlobalData later that month.

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FDA’s AI tool ‘Elsa’ is here, and the industry has questions

BioPharma Dive

Deep Dive Library Events Press Releases Topics Sign up Search Sign up Search Pharma Biotech FDA Clinical Trials Deals Drug Pricing Gene Therapy An article from FDA’s AI tool ‘Elsa’ is here, and the industry has questions The agency has provided only limited details about its AI pilot as it advances an “aggressive timeline” for the tool’s rollout.

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What Does the “Most Favored Nation” Executive Order Mean for Personal Use Imports?

FDA Law Blog: Biosimilars

Wasserstein We are still parsing through the May 12 Executive Order (EO), Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients and impacts this may have on the pharmaceutical industry. Of interest to these bloggers is the provision that deals with personal use importation. (We Please bear with us.)