Feliza Mirasol is the science editor for 

Videos

Dan Williams, CEO of SynaptixBio discusses drivers of rare disease drug development, including FDA incentives, priority review vouchers, and a growing recognition of unmet needs. 

Combination of Regulatory Incentives and Patient Advocacy Drive Rare-Disease Drug Development (Part 2)

Patrick Lavery is an Editor for the MJH Life Sciences brands 

. Previously at MJH, he filled the same role for 

Articles

Cereno reports that its lead program, CS1, demonstrated encouraging efficacy while meeting its primary endpoint of safety and tolerability in a Phase IIa trial.

Cereno Scientific’s PAH Treatment Gets FDA Fast Track Status

The laboratory services provider is responding to growing demand for packaging and microbiological testing by expanding its laboratory space at its Wiesbaden, Germany, facility.  

Nelson Labs Expands Laboratory Capacity and Services at German Facility

At a critical turning point in the adoption of digital tools across the bio/pharma industry, we want to hear from industry professionals on where things actually stand.

Digital Transformation in Pharma Manufacturing: Industry Perspectives Survey

Philip Hoersch is Director, Quality Assurance, Process Performance & System Compliance, Vetter.

Continued process verification ensures pharmaceutical manufacturing stays in control through data analysis, trend detection, and lifecycle monitoring.

Continued Process Verification Is Critical in Pharmaceutical Manufacturing

Gail Reed is senior scientist with Johnson & Johnson.

Joseph A. Albanese, director of Analytical Strategy and Compliance at Janssen Research and Development, LLC

Yelena Ionova is senior manager, Data Strategy and Analytics with Redica Systems.

J. Mark Wiggins is owner and compendial consultant with Global Pharmacopoeia Solutions LLC.

The authors propose a streamlined, efficient approach to determining specification equivalence that starts with a paper-based assessment of the methods and progresses to a data assessment for the methods under evaluation.

Specification Equivalence: A Practical Approach to Method and Acceptance Criteria Equivalence

The treatment becomes the only approved twice-yearly option for pre-exposure prophylaxis for HIV prevention in the European Union.

Gilead Sciences’ HIV PrEP Injectable Approved by European Commission

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

Behind the Headlines, Episode 23: Patent Cliff Deals, Tariff Pressures, and the In Vivo Cell Therapy Bet

This video clips offers topline findings from our survey of nearly 90 bio/pharma professionals on the impacts of Trump-era tariffs and trade policy.

Tariffs & Trade Policy: Results of a Bio/Pharma Peer Survey

This comprehensive overview of contemporary formulation strategies covers the drug product lifecycle from end to end, illustrating best practices for various formulation types seen through a CRDMO’s lens while also covering problem solving, the role of digital tools, and geopolitical changes.

News