European Pharmaceutical Review

JUNE 19, 2025

1,2 EMA’s draft reflection paper – implications for drug developers and manufacturers The proposed tailored approach offers opportunities for developers and manufacturers. 4,5,6 However, these benefits are contingent on the ability to generate comprehensive, high-quality analytical and PK data packages.

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Biosimilars Packaging Documentation Drug Development 97

Pharmaceutical Technology

JULY 11, 2025

The present clinical trial ecosystem is not equipped nor projected to have the capacity to satisfy this demand, and as a result the ecosystem is facing a potential slowdown in drug development. According to a November 2024 GlobalData report, per-trial costs have risen steadily since 2014, with single country trials increasing by 2.9%

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Drug Pricing Hospitals Medical Records Drug Development 52

Safe Biologics

NOVEMBER 12, 2023

6 would prevent the HHS Secretary from requiring a switching study as part of the data package to receive the interchangeable designation. Consider how these perverse incentives could prevent the development of the next Keytruda, the Merck miracle drug perhaps best known for helping former President Jimmy Carter beat cancer.

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Biosimilars Drug Pricing Packaging Labelling 130

European Pharmaceutical Review

FEBRUARY 7, 2023

Regulation of clinical trials Eight years following its adoption in 2014, the Clinical Trials Regulation 536/2014 (CTR) entered into application on 31 January 2022. Some of the current and anticipated proposals will not be adopted in 2023, or even before the end of tenure of the current European Commission in late 2024.

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Packaging Drug Development 117

European Pharmaceutical Review

DECEMBER 21, 2022

10 Diagnostics and biologics also heavily utilise carbon-based materials as constituting building blocks, processing aids, single-use reactors, or packaging materials. He is currently group leader of the Technology Development and Discovery Group at the Bioprocess Laboratory of the ETH. Chem Commun 2014, 50, 9650‒9652.

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Compounding Pharmaceutical Manufacturing Pharmaceutical Companies Pharmaceutical Companies 97

PharmaTech

JUNE 23, 2025

From the Dilantin package insert: “The free acid form of phenytoin is used in DILANTIN-125 Suspension and DILANTIN Infatabs. FDA, Guidance for Industry, Naming of Drug Products Containing Salt Drug Substances (CDER, June 2015). FDA, USP Salt Policy (December 2014). 1, 2014 (accessed April 29, 2025).

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Compounding Dosage Labelling Drug Development 52

PharmaTech

JUNE 6, 2025

Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations, Draft Guidance for Industry (CDER, CBER, 2019). Guideline on Similar Biological Medicinal Products Containing Biotechnology-derived Proteins as Active Substances: Quality Issues (revision 1) (May 22, 2014).

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Dosage Drug Development Documentation Biosimilars 52