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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.

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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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EU’s Pharma Package falls short of Europe’s goal of global competitiveness

Pharmaceutical Technology

How will RFK Jr’s American dream for vaccines play out? Go deeper with GlobalData Reports Chemotherapy in Pharmaceuticals: Platinum-based cancer drug composi. Reports Biosimilars in Immunology Data Insights The gold standard of business intelligence. Find out more Sign up for our daily news round-up!

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FDA approves KalVista’s Ekterly for hereditary angioedema

Pharmaceutical Technology

How will RFK Jr’s American dream for vaccines play out?

Packaging 122
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Vertex wins European approval for Alyftrek, bolstering cystic fibrosis stronghold

Pharmaceutical Technology

How will RFK Jr’s American dream for vaccines play out? Trikafta, known under the brand name Kaftrio in Europe, is the best-selling cystic fibrosis drug in the world, generating revenue of $11.02bn in 2024. Kaftrio loses patient protection in 2037, at which point biosimilars are set to enter the market.

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Big pharma braces for revenue headwinds as patent expiries loom

Pharmaceutical Technology

How will RFK Jr’s American dream for vaccines play out? Biosimilars and generics flood the market upon patent loss, which exerts pricing pressure on the branded product. There has been a push by the Trump administration to increase biosimilar and generic drug use in the US.