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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. “If

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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 is especially critical for temperature-sensitive biologics and vaccines, where maintaining proper storage conditions ensures product viability and regulatory compliance. Enhanced, continuous supply chain visibility is one of the most important elements of a safe, intelligent medication ecosystem.

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Do We Really Pay More for Prescription Drugs in the United States?

Pharmacy Times

Trump signed an executive order titled “Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients,” with the objective of lowering drug prices, namely on branded drug products, for American consumers. How Does Drug Pricing in the US Compare With Other Countries? REFERENCES 1.

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US trade tariffs and the potential impact on pharma supply chains

Pharmaceutical Technology

How will RFK Jr’s American dream for vaccines play out? i] Europe is set to face the biggest shockwaves of such a measure, since nearly one-third of all exports produced by the EU’s pharmaceutical sector are directed to the US. But this goes both ways, meaning retaliatory measures from the EU will also impact drug prices in the US.

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STAT+: Pharmalittle: We’re reading about Roche and Sanofi reactions to Trump, R&D rankings, and more

STAT

… Roche warned that President Trump’s executive order on drug pricing threatens its planned $50 billion investment in the United States , Reuters writes. The order directs drugmakers to lower prices of brand-name medicines to align with those in other wealthy nations. Best of luck, everyone.

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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.