Advancements in personalized medicine and other innovations are transforming the way dosage forms are viewed.

Reshaping Dosage Forms

This study aimed to develop a taste-masked drug resin complex using the ion exchange resin Kyron T-114.

Development of Taste-Masked Oral Dispersible Tablets of Cefpodoxime Proxetil

Novel genetic engineering technologies are transforming the design and manufacture of bispecific antibodies, which are emerging as a promising new class of biologics.

Frontrunners in Bispecific Antibodies

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Sean Milmo is a freelance writer based in Essex, UK.

Articles

The European Commission’s effort to relax supplementary protection certificates to help generic-drug makers and biosimilars producers has sparked strong opposition from the research-based pharmaceutical sector.

Disputes Over Manufacturing Waiver and Other SPC Exemptions

SÃ¡ndor KemÃ©ny* is an emeritus professor at Budapest University of Technology and Economics, Faculty of Chemical Technology and Biotechnology, Department of Chemical and Environmental Process Engineering.

MÃ¡tÃ© Mihalovits is a PhD student at Budapest University of Technology and Economics.

In Part I of this article series, the authors discussed the regression control chart method for identifying out-of-trend data in pharmaceutical stability studies. In Part II, the by-time-point method and the multivariate control chart method are investigated, and improved approaches are suggested. The method is illustrated using real data sets.

Methods for Identifying Out-of-Trend Data in Analysis of Stability Measurements—Part II: By-Time-Point and Multivariate Control Chart

In a recently released statement, FDA Commissioner Scott Gottlieb warned of an amino acids supply shortage and gave an update on a saline supply shortage, both due to the impact of hurricanes on Puerto Rican manufacturing facilities.

FDA Warns of Amino Acid Shortage Due to Hurricane Maria

Biocad and Sothema Labs have partnered to release cancer-treating biosimilars into the North African market.

Biocad Announces New Manufacturing Site in North Africa

The acquisition gives GE Healthcare access to a nanofiber-based platform purification technology that can offer improvements in biopharmaceutical productivity.

GE Healthcare Completes Acquisition of Bioprocessing Start-Up

In the wake of generic-drug pricing pressure and declining revenues, Teva has restructured its commercial business and made executive leadership changes.

Teva Restructures Company and Leadership

Ontruzant is the first biosimilar of Roche’s Herceptin (trastuzumab) to be approved in Europe. 

Samsung Bioepis Receives Approval for First Trastuzumab Biosimilar, Ontruzant, in Europe

Adrian Wildfire is project director, Infectious Diseases &Viral Challenge Unit, SGS Life SciencesâClinical Research.

Challenge trials may increase in coming years as new and improved challenge agents better emulate “natural” disease states. 

Using Human Challenge Trials to Develop Flu Vaccines

Agnes Shanley is senior editor of Pharmaceutical Technology.

Despite the challenges and high cost of development, vaccine innovation is at an all-time high, as new approaches aim to improve global access.

Making Vaccines Accessible

Amber Lowry is an associate editor at UBM plc.

This article explores some of the challenges, services, and technologies that go into ensuring that vaccines are properly temperature controlled and maintain product integrity for delivery to patients.