Quality Systems

Patrick Lavery is an Editor for the MJH Life Sciences brands 

. Previously at MJH, he filled the same role for 

Articles

The company said that Vyvgart (efgartigimod alfa) is the first novel mechanism of action for CIDP treatment in more than 30 years.

CHMP Recommends argenx Treatment for Chronic Inflammatory Demyelinating Polyneuropathy

The policy announced by Commissioner Martin A. Makary, MD, will not preclude employees of regulated companies from presenting their views to committees, and rare exceptions will be allowed.

FDA Announces New Policy on Advisory Committee Members

The recombinant vaccine, under the brand name Vimkunya, is recommended for persons age 12 and older who are traveling to a country or territory where there is a chikungunya outbreak.

Bavarian Nordic Chikungunya Vaccine Recommended by CDC's ACIP

Vitrakvi (larotrectinib) was first granted accelerated approval by FDA in November 2018.

Bayer Announces FDA’s First Full Approval of NTRK Inhibitor

Development of the state-of-the-art facility was made possible by a £2 million (US$2.6 million) round of funding, and a successful inspection by MHRA was completed in March 2025.

BDD Opens GMP Manufacturing Facility in Scotland

Videos

Even with, or perhaps because of, the rapidity with which changes in United States policy are developing, many in the bio/pharmaceutical industry are taking a longer view.

Tariff Pause Reinforces Uncertainty Among Biopharma Professionals

As single use becomes more prevalent, end users are looking for more customization, and regulators are refining their rules, says Todd Andrews of CPC in an interview with Pharmaceutical Technology® Group.

INTERPHEX 2025: ‘Breaking Up the Octopus’ of Single-Use Systems

 is a PhD student in the Department of Pharmaceutics, UCL School of Pharmacy, University College London.

 is a professor in the Department of Pharmacology, Pharmacy and Pharmaceutical Technology, University of Santiago de Compostela, honorary lecturer in the Department of Pharmaceutics, UCL School of Pharmacy, University College London, and co-founder of FABRX Ltd and FABRX Artificial Intelligence.

 is a professor in the Department of Pharmaceutics, UCL School of Pharmacy, University College London and co-founder of FABRX Ltd.

3D printing of personalized medications is currently possible under existing compounding regulations, offering enhanced process control through automation. But new legislation coming in 2025 will allow 3D printing as part of a distributed manufacturing framework.

Entering New Domains for 3D Printing of Drug Products

 is product manager, analytical services at Stevanato Group.

 is scientific director at Nelson Labs Europe.

The authors examine the risks of extractables and leachables, and present solutions that emphasize the importance of a strategic, multi-prong approach.

Extractable and Leachable Challenges in Lyophilized Drug Products

Three of the five are biosimilars, and seven additional medicines received recommendations for indication extensions.

Regulatory Oversight and Compliance