Drug Development

How will plans to rework medicines legislation in the European Union impact drug development, innovation, and market exclusivity?

Executive Director Emer Cooke presents EMA’s achievements for the year.

The authors detail a practical application of specification equivalence to excipients testing to achieve in-house harmonization.

The approval was granted to USAntibiotics, with FDA saying it addresses pronounced antibiotic shortages in the past two decades.

The agency is approaching the new overhaul as a chance to reshape drug regulations in the European Union.

Co-legislators in Europe have reached a provisional agreement on a new pharmaceutical policy framework to help boost competitiveness, innovation, and supply chain security.

The collaboration will initially focus on advanced stages of solid cancers such as colorectal, pancreatic, lung, and breast, but may expand to other cancer types in the future.

New drug delivery systems prioritize convenience and customization, using advanced technologies like nano-engineering and non-invasive routes to improve patient outcomes.

Increasing demand, complexity, and potency are driving innovation and investment in HPAPIs.

The articles in this issue reflect an industry in transition, committed to innovation while ensuring safe, reliable, and forward-looking pharmaceutical production.

Though not an actual creature, the aptly named longevity fund has announced a strategic investment in Etheros’ development of a new class of drugs.

Large-language models are excellent for general-use AI systems, but they don’t understand pharmaceutical companies’ proprietary documentation—the validated procedures and quality protocols that ensure drug safety. Smaller, domain-specific language models give companies more control and efficiency in their AI use.

FDA has granted orphan drug designation to FS2 (kynurenic acid) for the investigational treatment of idiopathic pulmonary fibrosis.

Live cell phenotypic screening can enhance translational predictability and speed up lead optimization.

The first patient visit has taken place for the SURMOUNT-REAL UK clinical trial of Eli Lilly and Company’s weight-loss drug, tirzepatide.

Machine learning tools are now moving from concept to validated applications, driving transformative shifts in bioanalysis, preclinical testing, and formulation optimization across the industry.

The European Union aims to become the most attractive destination for clinical research.

Corey Bloom of Lonza outlines major points from his AAPS presentation, from drug delivery technology selection to the importance of CDMO partnerships.

Take our survey to voice your opinions on the bio/pharma industry impacts of the FDA Commissioner’s National Priority Vouchers program.

PharmSci 360 will spotlight the economics behind AI, scale-up, and advanced modalities, addressing cost barriers that influence future drug manufacturing.

Pharmaceutical Technology® spoke with Dr. Mark Arnold, owner and principal, Bioanalytical Solution Integration, ahead of AAPS PharmSci 360 to find out how bioanalysis enhances bio/pharmaceutical drug development.

Pharmaceutical Technology® spoke with Peter Freed, head of Global Pharma CTS, Roquette, about a variety of materials-related topics including protein stability, tablet coating, sustainability, and securing the supply chain.

React4Life’s Silvia Scaglione emphasizes how organ-on-chip tech and AI are reshaping drug testing, personalized treatment, and the future of bio/pharma innovation.

Pharmaceutical Technology® spoke with Dr. Weite Oldenziel, CEO of Ofichem, before CPHI Frankfurt 2025 to get his perspective on the API market and why it is important to qualify API suppliers.

Radiopharmaceuticals are allowing for the targeted treatment of cancers, but they do pose challenges.