RAPS

Oligonucleotides: EMA drafts new guideline on manufacturing and development

The European Medicines Agency (EMA) on Monday issued a guideline that sets out the type of information required to develop, manufacture, and control new and existing oligonucleotide drugs. EMA said ...
RAPS

EMA Finalizes Process Validation Guidance

The European Medicines Agency (EMA) has finalized guidance intended to help sponsors meet the data requirements for process validation for biotechnology-derived active substances. The guidance, which ...
GEN - Genetic Engineering and Biotechnology News

What’s Next in the Evolution of Standards for Biologics Development

The growing complexity of the field reinforces the need for standards ensuring product quality, consistency, and patient ...
Hosted on MSN

FDA and EMA unveil stricter biologics compliance agendas

The FDA and EMA have set out updated regulatory agendas that will shape biologics manufacturing standards in coming years. The FDA’s Center for Biologics Evaluation and Research (CBER) 2026 agenda ...
Seeking Alpha

Nurexone Biologic Initiates European Orphan Drug Designation Process Following U.S. Grant

TORONTO and HAIFA, Israel, Feb. 02, 2024 (GLOBE NEWSWIRE) -- NurExone Biologic Inc. (NRX:CA) (FSE: J90) (NRX.V), known as "NurExone," is pleased to announce the initiation of the Orphan Drug ...