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An interview with Franco Negron
In this interview, we spoke with Franco Negron, CEO of Simtra, about how the company is advancing its position as a premier CDMO for sterile injectables while preparing for the next wave of complex biologics. read more
Should Sponsors Provide Source Document Templates?
Sponsor-provided templates provide a compelling opportunity to improve upstream trial execution. However, in today’s world of increasingly complex and data-driven trials, the opportunity comes with important caveats. read more
An Interview With Christoph van Eickels, Dr. Deepak Venkanna, and Holly Olmstead
Executive Q&A topic: Regulatory Requirements for Upstream Bioprocess Solutions read more
Horizon Lines: A Quarterly Review of NDAs – July-September 2025
This quarterly review on New Drug Applications contains data for applications approved during the third quarter of 2025, which includes New Molecular Entities (NMEs) and new biologics. A total of 48 applications were approved by the FDA during these three months. read more

Clinical Trials - Transforming Drug Development
Transforming Drug Development: Accelerating Clinical Trials through Patient-Centric Innovations and Technological Breakthroughs Watch Now

Simtra BioPharma Taps SCW.AI for Digital Factory Initiative
Tuesday, May 19, 2026
Simtra BioPharma Solutions has entered into a co-innovation partnership with SCW.AI to implement a digital factory platform across its sterile ... read more
Wacker Introduces Contract Research Services for Nucleic Acid Therapies
Tuesday, May 19, 2026
Wacker has launched Contract Research Services (CRS) to support biotech and biopharma companies developing nucleic acid-based medicines. read more
FAMAR Group Signs Contract Manufacturing Agreement with GE HealthCare
Tuesday, May 19, 2026
FAMAR Group has signed a contract manufacturing agreement with GE HealthCare to fill and finish vials of GE HealthCare's iodine-based contrast media, ... read more
Thermo Fisher Scientific’s PPD Clinical Research Business Expands Bioanalytical Capabilities with New Laboratory in Gothenburg, Sweden
Tuesday, May 19, 2026
Thermo Fisher Scientific announced the opening of a new bioanalytical and biomarker laboratory in Gothenburg, Sweden, located within GoCo Health ... read more
LOTTE Biologics Expands Antibody Manufacturing Agreement with Ottimo Pharma
Monday, May 18, 2026
LOTTE Biologics announced an expansion of its collaboration with Ottimo Pharma, a biotech company developing one-of-a-kind PD-1/VEGFR2 dual-paratopic ... read more