Quality Systems

Articles

A new platform allowing market authorization holders to report drug shortages has gone live. 

EMA Announces Drug Monitoring Platform

Nicholas Saraceno is editor at Pharmaceutical Commerce.

FDA's approval will allow Kedrion to manufacture Ryplazim (plasminogen, human-tvmh), the only FDA-approved therapy for treating PLGD-1, at facility in Bolognana, Italy.

FDA Grants Approval to Kedrion to Produce PLGD-1 Therapeutic at Bolognana Plant

Feliza Mirasol is the science editor for 

FDA's approval of eladocagene exuparvovec-tneq (Kebilidi) makes that product the first FDA-approved gene therapy for treating AADC deficiency.

PTC Therapeutics Gains FDA Approval for AADC Deficiency Gene Therapy

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

CHMP has granted Eisai Europe and Biogen a positive opinion for the use of their monoclonal antibody therapy in treating early Alzheimer’s disease.

EMA’s CHMP Gives Positive Opinion for Use of Lecanemab in Early Alzheimer’s Disease

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

Videos

Brian Feth and Jonathan Grinstein go behind the headlines to discuss the impact of a Republican administration on Federal Trade Commission actions, tax relief, and Health and Human Services (HHS) leadership; as well as advancements in CAR-T.

Behind the Headlines: What the U.S. Election Results Mean for Industry, In Vivo CAR-T Applications, and more 

Balversa (erdafitinib) marks the first and only bladder cancer therapy to target FGFR3 alterations, with a demonstrated increase in overall survival from 7.8 months to 12.1 months. 

J&J’s Balversa Gains MHRA Marketing Authorization as Monotherapy for Bladder Cancer

Pharmaceutical training programs are enhanced by integrating ICH quality risk management considerations.

Application of Validation Principles to the Training Quality System: Part 9, Quality Risk Management Hazard Identification

CDER Director Patrizia Cavazzoni and CBER Director Peter Marks provided an update on the rare disease innovation hub in a new FDA Voices blog post.

FDA Rare Disease Innovation Moves Forward

Patrick Lavery is an Editor for the MJH Life Sciences brands 

. Previously at MJH, he filled the same role for 

The treatment for ATTR in certain adults with polyneuropathy had just been recommended for approval across the European Union and had gained regulatory approval in the United States at the end of 2023.

AstraZeneca’s Wainzua Gains Another Approval in England and Wales

A new laboratory will be built in Oss, while additional capacity and capabilities will be added to the Bioanalytical Center of Excellence in Assen.

Regulatory Oversight and Compliance