Articles

The final guidance provides specific recommendations for CMC, pharmacology, toxicology, and clinical study design for CAR-T cell products.

FDA Issues Guidance on CAR-T Cell Product Development

Chris Spivey is director of Industry Relations and Strategic Partnership, MJH Life Sciences.

An interview with Steffen Thirstrup, chief medical officer, European Medicines Agency (EMA).

Europa Perspectives—Pan-European Challenges and Solutions Post Brexit

The immune-resetting peptide, developed by Revolo Biotherapeutics, received positive results from its Phase IIb study.

FDA Grants Orphan Drug Designation to First-in-Class Treatment for Eosinophilic Esophagitis

The final guidance provides recommendations for developing gene therapy products incorporating genome editing of human somatic cells.

FDA Give Guidance on Human Genome Editing in Gene Therapies

Felicity Thomas is Associate Editorial Director of Pharmaceutical Technology, Pharmaceutical Technology Europe, BioPharm International.

Videos

In this exclusive Drug Digest video interview, Felicity Thomas, Europe/senior editor, Pharmaceutical Technology Group, interviews an esteemed panel of experts from IPEC Americas about excipient grades.

Drug Digest: Making the Grade: The Importance of Using the Correct Excipient Grade in Drug Products

IMU Biosciences has secured £11.5 million in its Series A financing round.

IMU Biosciences Raises Millions in Series A Funding Round

The company issued the recall because of a package mislabeling problem.

Azurity Recalls Zenzedi

The acquisition adds a potential rare disease asset to Sanofi’s alpha-1 antitrypsin deficiency pipeline.

Sanofi to Aquire Inhibrx for $1.7 Billion

Getinge has announced the inauguration of its new Global Centre of Excellence for Chemistry in the United Kingdom

Getinge Brings Chemistry and Instrument Decontamination Under One Roof

The annual industry report of the Pharmapack Europe event suggests there will be significant innovation in inhaled pulmonary and intranasal drug delivery in 2024.

News