Drug Development

Articles

Moderna has initiated a rolling submission process with FDA for a biologics license application for its mRNA COVID-19 vaccine for individuals 18 years of age and older.

Moderna Initiates Rolling Submission of Biologics License Application for its COVID-19 Vaccine

Rita Peters is the former editorial director of 

Pharmaceutical Technology, Pharmaceutical Technology Europe

Bio/pharmaceutical manufacturers have made a good first step toward global vaccination through pledging doses at no- to low-profit rates. 

A “We are the World” Vaccination Effort?

Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.

In the face of a growing clamor for greater worldwide access to COVID-19 vaccines, biopharma companies are promising to expand distribution of free and low-cost preventives to curb the pandemic globally. 

Vaccine Makers Ramp Up Production, Donations to Protect IP

EMA has provided further advice to healthcare professionals on blood clots and low blood platelets occurring after vaccination with Vaxzevria (formerly the COVID-19 Vaccine AstraZeneca).

Further Advice on Vaxzevria Issued in Europe

Moderna and Aldevron have expanded their existing collaboration to support Moderna’s COVID-19 vaccine program as well as additional clinical programs in Moderna’s pipeline.

Moderna and Aldevron Expand Partnership for mRNA Vaccine and Therapeutic Pipeline

Codagenix and Univercells have partnered on a research collaboration to pursue an undisclosed, high-priority human vaccine target.

Codagenix and Univercells Collaborate on Vaccine Research for Undisclosed Target

In the study, which enrolled 3700 US participants ages 12 to less than 18 years, no cases of COVID-19 were found in participants who had received two doses of the Moderna COVID-19 vaccine.

Moderna’s COVID-19 Vaccine Study in Adolescents Has Met its Primary Endpoints

Samsung Biologics plans to support the production of hundreds of millions of doses of Moderna’s vaccine to supply to markets outside of the United States beginning in the third quarter of 2021. 

Moderna and Samsung Biologics Partner on Fill/Finish Manufacturing of Moderna’s COVID-19 Vaccine

The agency is authorizing extending the time undiluted, thawed vaccine vials can be stored in the refrigerator to one month.

FDA Authorizes Increased Storage Time of Thawed Pfizer/BioNTech COVID-19 Vaccine

Pfizer and BioNTech have entered into a new agreement with the European Commission to supply 900 million doses of Comirnaty to the European Union with an option to request up to 900 million additional doses.

Formulation and Drug Delivery