Drug Development

Articles

The approval is based on results from the pivotal EFFISAYIL 1 Phase II clinical trial.

European Commission Approves Spevigo for Generalized Psoriasis Flares

mRNA-1273.222 has also received FDA EUA for children and adolescents between six and 17 years of age and for adults over the age of 18 years of age.

Moderna Receives FDA Emergency Use Authorization for Omicron-Targeting Bivalent COVID-19 Booster Vaccine in Children 

The guidance discusses statistical approaches for BE comparisons and focuses on how to use these approaches both generally and in specific situations.

FDA Publishes Draft Guidance on Statistical Approaches to Establishing Bioequivalence

Wai-Chi Man is IC/SP product marketing manager at Thermo Fisher Scientific.

One can improve method precision and productivity by replacing one step in sample preparation with an automated approach.



Automating Glycoprotein Analysis for Vaccine Manufacture

Cynthia A. Challener is a contributing editor to Pharmaceutical Technology.

Unique solutions are required to protect inherently unstable messenger RNA.

Managing mRNA Instability During Formulation, Manufacturing, and Shipment

The decision to move forward in Phase III development stems from the threat of resistance to current malaria treatment growth. 

Phase III Study for Novel Ganaplacide/Lumefantrine-SDF Combination in Adults, Children with Malaria Announced

Feliza Mirasol is the science editor for 

Podcasts

A look back at challenge and innovation highlights in 2022 for oral solid dosage forms, this podcast episode will review industry experts’ takes on factors driving the evolution of OSD forms as well as innovations in APIs, technology, and methodology. 

Drug Solutions Podcast: Oral Solid Dosage Forms: A Look Back at Challenges and Innovations

Sam Turner is director of Technology and Development at Capcium.

Naresh Talwar, PhD, is director of Product Development at Capcium.

Ajay Pazhayattil*, M.Pharm, DBA, Ajay.Pazhayattil@capcium.com, is vice-president, Scientific and Regulatory Affairs at Capcium.

Advancements in soft capsule technology can enable the development of soft capsule formulations, which are becoming the preferred method of oral administration.

Novel Formulations and Line Extensions with Soft Capsule Technology

High-concentration injectable formulations present unique challenges.

Excipients for Solubility Enhancement of Parenteral Formulations

Felicity Thomas is the former Associate Editorial Director of Pharmaceutical Technology, Pharmaceutical Technology Europe, BioPharm International.

Opportunities and developments in particle engineering are providing developers with the tools to advance drug candidates successfully.

Formulation and Drug Delivery