Quality Systems

Patrick Lavery is an Editor for the MJH Life Sciences brands 

. Previously at MJH, he filled the same role for 

Articles

The reopening of comments addresses the addition of a warning to consumers that acetaminophen may cause skin irritation characterized by reddening, blisters, and rashes.

FDA Order on OTC Monograph Drugs Containing Acetaminophen Gets Renewed Comment Period

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

Synovial sarcoma is a rare form of cancer impacting about 1000 adults in the United States each year, most of them men in their 30s or younger.

First Gene Therapy for Adults with Metastatic Synovial Sarcoma Approved by FDA

Innovative solutions are making personalized cell and gene therapies accessible to all.

Frontrunners in Automated Cell and Gene Therapy Manufacturing

Felicity Thomas is the former 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

Feliza Mirasol is the science editor for 

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

An additional 11 medicines were recommended for extension of therapeutic indications, while one negative opinion was issued.

CHMP Recommends 14 Medicines for Approval at July Meeting

The questions come as FDA is revisiting best practices for advancing the development of new biosimilar products under the terms of its updated Biosimilars Action Plan.

FDA Asks for Input on Guidance Documents for Biosimilar Product Development

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.

GSK’s Application Seeking Blenrep Combinations for Treating Multiple Myeloma Accepted by EMA

Combination products may be reviewed in a single application or in separate applications for each constituent part, and in rare cases, FDA may decide which type of application process is appropriate.

Regulatory Oversight and Compliance