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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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NHC Submits Comments on Section 232 National Security Investigation of Imports of Pharmaceuticals and Pharmaceutical Ingredients

Putting Patients First Blog

4 ,5 Millions of Americans rely on medicines that are manufactured outside the United States, particularly from close and longstanding allies such as Ireland, Switzerland, and the United Kingdomcountries whose regulatory frameworks for pharmaceutical manufacturing mirror the high standards enforced domestically.

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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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Survey: Impacts of Tariffs & Trade Policy on the Bio/pharmaceutical Industry

PharmaTech

The industry's dependence on geopolitical stability and predictable trade relationships is increasingly critical for global pharmaceutical manufacturing. Regulatory complexities and inconsistent enforcement further compound these challenges, complicating long-term planning for compliance, cost forecasting, and sourcing.

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As Trump Pharma Tariff Deadline Looms, Here's How the Sector Got Here

Pharmaceutical Commerce

Tariffs on China will make generic drug prices go up I assume because China is such an important supplier of active pharmaceutical ingredients, as well as finished products.” 18 – The US announces it plans to improve a tariff of 25% or higher on pharmaceuticals. Pharmaceutical Commerce. Pharmaceutical Commerce.

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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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Examining the One Big Beautiful Bill Act on Prescription Drugs: Benefits and Criticisms

Pharmacy Times

2 Although seen as restoring incentives for rare disease research, critics argue it perpetuates high pricing and industry-friendly policy. The OBBB expanded the list of drugs exempt from negotiation and delayed implementation of new price controls.