News

FDA Issues Guidance on CAR-T Cell Product Development

February 01, 2024

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

Europa Perspectives—Pan-European Challenges and Solutions Post Brexit

February 01, 2024

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

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

January 31, 2024

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

FDA Give Guidance on Human Genome Editing in Gene Therapies

January 31, 2024

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

IMU Biosciences Raises Millions in Series A Funding Round

January 30, 2024

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

Azurity Recalls Zenzedi

January 29, 2024

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

Sanofi to Aquire Inhibrx for $1.7 Billion

January 29, 2024

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

Getinge Brings Chemistry and Instrument Decontamination Under One Roof

January 26, 2024

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

Pharmapack Report Points to Inhaled Pulmonary and Intranasal Drug Delivery as Areas to Watch

January 26, 2024

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

Winners of the 2024 Pharmapack Europe Awards are Announced

January 25, 2024

The 2024 Pharmapack Europe Award winners include companies involved in ground-breaking innovations in novel drug delivery solutions, reusable connected devices, and recyclable packaging.