Formulation and Drug Delivery

EMA Starts Rolling Review of Moderna’s COVID-19 Vaccine Candidate

November 19, 2020

Moderna has reported that EMA's CHMP has started a rolling review of mRNA-1273—Moderna’s COVID-19 vaccine candidate.

FDA Commits to Transparency in EUA Reviews

November 18, 2020

Stephen Hahn promises disclosure of supporting scientific data used to issue EUAs.

Lilly’s COVID-19 mAb Treatment Receives EUA

November 10, 2020

FDA issued emergency use authorization for bamlanivimab for patients at risk for severe COVID-19.

FDA Grants Fast Track Designation to Novavax’s COVID-19 Vaccine Candidate

November 10, 2020

The vaccine will enter into a Phase III clinical trial in the United States and Mexico by the end of November, which could potentially support global authorization and approval of the vaccine.

Pfizer: COVID-19 Vaccine Shows High Efficacy

November 09, 2020

Interim efficacy data suggests the Pfizer/BioNTech has an efficacy rate above 90%.

Understanding Excipient Quality and Impact on Formulation

November 04, 2020

At the 2020 Bio/Pharma Virtual Congress, experts discuss the importance of characterizing excipients to ensure quality, safety, and effective performance.

Pandemic Response Lessons for Biopharma Companies

November 04, 2020

Biopharma can apply new manufacturing practices adopted during the COVID-19 pandemic to enhance bioprocessing.

EDQM Releases Document on Recombinant Viral Vectored Vaccines for COVID-19

November 03, 2020

The document provides analytical strategy options for the control of recombinant viral vectored vaccines to support COVID-19 vaccine developers.

Chewable Tablets: A Review of Formulation Considerations

November 03, 2020

This paper reviews considerations for the formulation of chewable tablets including sensory characteristics, chewability assessment, and drug release.

Improving Solubility with Amorphous Solid Dispersions

November 03, 2020

Amorphous solid dispersions are a useful tool in overcoming solubility issues, but they have not yet reached full potential in commercial success.