Topic

Patrick Lavery is an Editor for the MJH Life Sciences brands 

. Previously at MJH, he filled the same role for 

Articles

The program, for which visits will be scheduled through September 2025, does not replace or supplement a regulatory inspection.

Drug Companies Encouraged by FDA to Participate in FY 2025 Site Visitation Program

 is Industry Market Manager Biopharma, Pharma EMEA - Brenntag GmbH.

Biopharmaceutical production faces the challenge of ensuring the quality of raw materials due to a lack of specific guidelines. By implementing effective risk assessment strategies and working with reliable, selected solution providers, biopharmaceutical manufacturers can minimize these challenges and improve product quality.

The Quest for Quality: Challenges and Strategies in Raw Material Selection for Biopharmaceuticals

Enamine’s library of 5400 TPD-related linkers, and 13,000 more linker molecules, is now being integrated into Cresset’s Spark tool for library searching.

Cresset, Enamine Extend Targeted Protein Degradation Collaboration

Feliza Mirasol is the science editor for 

Manual and automated inspection technologies have their own advantages and limitations.

Considerations for Finished Product Inspection Systems

Cheryl Barton is director of PharmaVision, 

Germany’s Medical Research Act allows pharmaceutical companies to keep drug prices confidential.

Germany Amends and Approves the New Medical Research Act

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

Potential conflicts of interest with advisory group members have led to EMA’s impartiality coming into questioned for some marketing authorization decisions. 

Demanding Impartiality

STADA and Alvotech have launched Uzpruvo in Europe, making it the first approved biosimilar to Stelara (ustekinumab) in the European market.

First Approved Stelara Biosimilar Launched in Europe by STADA and Alvotech

The US Pharmacopeia’s Microbiology Expert Committee approved the inclusion of a chapter into the United States Pharmacopeia–National Formulary that allows the use of non-animal-derived reagents for endotoxin testing.

USP Permits Use of Non-Animal-Derived Reagents for Endotoxin Testing

The HemoTemp II Blood Bag Temperature Indicator, which is an FDA-approved medical device, and the HemoTemp II Activator both were given the “Standards-Compliant” seal.

Two SpotSee Products Receive AABB Standards Accreditation

GSK's MAA is supported by an interim analyis of Phase III trials, which demonstrated significant progression-free survival benefit and positive overall survival trends from Blenrep combination therapies.

Quality Systems