Dosage Forms

Articles

The agency issued guidance for developers of vaccines, diagnostics, and therapeutics to address variants of the COVID-19 virus.

FDA Gives Guidance on COVID-19 Variants

Once the vaccine has been authorized, Sanofi will provide Johnson & Johnson with access to its vaccine manufacturing plant in Marcy l’Etoile, France, to formulate and fill vials of the vaccine, at a rate of 12 million doses per month.

Sanofi to Support the Manufacturing of Janssen’s Single-Dose COVID-19 Vaccine

The companies have expanded their existing partnership to include 40 Million Doses of COVID-19 vaccine for South Korea.

Novavax Expands COVID-19 Collaboration and License Agreement with SK Bioscience 

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

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

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

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

The EC intends to get tougher on issues such as reliability of drug supplies, particularly essential medicines.

Getting Tough on Supplies

Rita Peters is the former editorial director of 

Pharmaceutical Technology, Pharmaceutical Technology Europe

A complicated vaccination rollout and mixed messages may derail the pandemic endgame.