Drug Development

Articles

The EC has granted marketing authorization to Celltrion Healthcare for its adalimumab biosimilar, Yuflyma (CT-P17).

EC Approves Celltrion Healthcare’s Adalimumab Biosimilar

The US government will pay $1.95 billion for the additional 100 million doses, bringing the total number of doses supplied by the companies up to 300 million.

Pfizer and BioNTech to Supply 100 Million Additional Doses of COVID-19 Vaccine to United States

Nanoform and Herantis have signed a biologics proof of concept agreement for formulation proof of concept projects aimed at improving nasal drug delivery to the brain.

Nanoform, Herantis Collaborate on Nasal Drug Delivery to the Brain of Biologics

Videos

Lessons learned from the pandemic can advance future biologic drug development and manufacturing.

Pandemic Response Lessons

The agency is developing guidance to help manufacturers make changes to existing COVID-19 vaccines to treat new variants in the coronavirus.

EMA Guidance on Changes to COVID-19 Vaccines to Fight Variants

FDA’s Vaccines and Related Biological Products Advisory Committee will meet on Feb. 26, 2021 to discuss the request for emergency use authorization for Janssen Biotech’s COVID-19 vaccine candidate.

FDA Sets Date for Advisory Meeting to Discuss Janssen COVID-19 Vaccine EUA

The CGMP manufacturing agreement will expand production of lenzilumab, a candidate for COVID-19 therapy, to support a potential emergency use authorization filing.

Avid Bioservices Enters Manufacturing Agreement with Humanigen for Lenzilumab

Both companies will provide resources and expertise to research, develop, and manufacture multiple mRNA vaccine candidates, including multi-valent and monovalent approaches. 

GSK and CureVac to Collaborate on Next-Generation COVID-19 Vaccines

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

Plasma-based proteins and cell-based therapies have significant potential to address unmet medical needs.

Exploring the Therapeutic Value of Blood Components

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

Rapid growth in biologics and increasing complexity of new compounds are some of the factors driving development of innovative delivery solutions.

Formulation and Drug Delivery