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European PFAS restriction could jeopardise pharmaceutical manufacturing

European Pharmaceutical Review

According to the European Federation of Pharmaceutical Industries and Associations (EFPIA), more than 600 essential medicines are at risk if a proposed restriction on the use of fluorinated substances, per- and polyfluoroalkyl substances (PFAS) across pharmaceutical manufacturing in the EEA, is implemented.

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The Fourth Circuit Upholds CMS’ Definition of “Line-Extension Drug” and “New Formulation”

FDA Law Blog: Biosimilars

Gaulkin — On April 10, the Fourth Circuit unanimously affirmed a summary judgment ruling for the Centers for Medicare & Medicaid Services (CMS) regarding the agency’s definitions of “line-extension drug” and “new formulation” for purposes of determining rebates that drug manufacturers may owe the Medicaid Drug Rebate Program (MDRP).

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PDA revises report on glass container manufacturing

European Pharmaceutical Review

43: Identification and Classification of Nonconformities in Moulded and Tubular Glass Containers for Pharmaceutical Manufacturing. Specifically, the document covers the development process of glass containers for pharmaceutical products, glass container sampling as well as definition of lots.

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Guaranteeing resilience in vaccine manufacturing

European Pharmaceutical Review

For new technologies that have emerged in the last five years, “compared to some of the traditional methods, [technologies such as mRNA] are faster, sometimes more accurate also and definitely can be industrialised and manufactured within a shorter period of time.

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CMS Issues Proposed Rule on the Medicare Part B and Part D Inflation Rebate Program; HPM Issues Detailed Summary

FDA Law Blog: Biosimilars

Gaulkin — Enacted in 2022, the Inflation Reduction Act (IRA) amended the Medicare provisions of the Social Security Act to impose several discount requirements on pharmaceutical manufacturers.

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AmerisourceBergen agrees to acquire PharmaLex for $1.29bn

Pharmaceutical Technology

AmerisourceBergen has entered a definitive agreement for the acquisition of PharmaLex from Auctus Capital Partners in a deal worth $1.29bn (€1.28bn) in cash, subject to specific adjustments.

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National Health Council Updates its Patient Engagement Fair-Market Value Calculator

Putting Patients First Blog

This definition is also applicable across stakeholders and engagement activities (e.g., pharmaceutical manufacturers, academic centers, or other patient organizations). participation in an interview, focus group).