News

Second COVID-19 Vaccine Granted EUA, Ships for Immediate Use

December 21, 2020

Moderna’s mRNA vaccine to prevent COVID-19 disease is granted FDA Emergency Use Authorization and CDC recommendation.

FDA Publishes Guidance on CRLs Response Timelines during Pandemic

December 21, 2020

The guidance provides information on review timelines during the COVID-19 pandemic.

CHMP Gives Positive Opinion for Pfizer-BioNTech Vaccine

December 21, 2020

A decision by the European Commission on conditional marketing authorization for the European Union’s first COVID-19 vaccine is expected soon.

FDA Issues Guidance on Complex Innovative Trial Designs

December 18, 2020

The new guidance provides information on how sponsors should interact with the agency regarding complex innovative trial design proposals.

FDA Answers COVID-19 Vaccine Questions

December 18, 2020

The agency is answering frequently asked questions about the Pfizer–BioNTech COVID-19 vaccine on its website.

FDA Advisors Recommend Moderna’s COVID-19 Vaccine

December 18, 2020

FDA is expected to issue Emergency Use Authorization for Moderna’s vaccine, enabling immediate distribution.

Helena Offers Polymer Solution to Global Cold Chain Issues for COVID-19 Vaccines, Biologics, and Therapeutics

December 16, 2020

A newly developed polymer, DynaShield, may have the capability to ensure global access for COVID-19 treatment and prevention.

FDA Approves First-of-its-Kind Genomically Altered Line of Pigs for Potential Therapeutic Uses

December 16, 2020

The product represents a first-of-its-kind intentional genomic alteration in a line of domestic pigs that may be used for human therapeutics.

ACG Films Expands its Portfolio of Ultra-High Barrier Blister Films

December 16, 2020

The films are now available in three options of varying thickness for added protection against moisture and oxygen.

Moderna Enters into Supply Agreement to Provide Singapore with its COVID-19 Vaccine

December 16, 2020

The company has formed an agreement with the Ministry of Health of Singapore to supply mRNA-1273, Moderna’s COVID-19 vaccine candidate, to the people of Singapore.