Shilpa Gadgil, PhD (VP, Head of Process and Analytical Development, Head of CDMO Development) discusses Enzene's new technologies and the New Jersey site capabilities.

This paper explores the legal and regulatory framework around 3D drug printing, particularly for personalized medicine, ...

Centogene NV and ROPAD consortium publish data from a landmark study identifying genetic variants that may respond to ...

A statistical procedure based on a quality range is proposed for demonstrating comparability between pre-change and ...

The draft guidance provides information on the agency’s accelerated approval process and criteria for approval.

1. CPHI. Saudi Arabia Poised to Expand Domestic Manufacturing Eco-system as 30,000 Attendees join Inaugural CPHI Middle East. Press Release. Dec. 9, 2024. The draft guidance provides information on ...

In this exclusive Drug Digest video interview an industry expert discusses key trends impacting solid dosage drug development ...

LNPs have gained solid ground as a drug delivery system for mRNA due to their success in the vaccines arena.

The 340B Drug Pricing Program was created by Congress back in 1992 as a way to help vulnerable patients have access to ...

Edwin Stone, Bernard Sagaert, and Khaled Yamout go behind the headlines to discuss what the ongoing measles outbreak in the ...

All CGMP requirements, including supporting activities, are critical in aseptic sterile manufacturing to ensure product ...

When referring to this article, please cite it as Thomas, F. New Year, New PTE. Pharmaceutical Technology Europe 2024 36 (10) ...