Formulation and Drug Delivery

US Government Awards Moderna $1.5 billion for COVID-19 Vaccine Candidate

August 13, 2020

In combination with BARDA’s previous award, the commitment for early access to Moderna’s vaccine candidate has now reached to up to $2.48 billion.

Henlius and Accord Healthcare Receive European Approval for Biosimilar Trastuzumab

August 13, 2020

The companies received approval from the EC for Zercepac (HLX02), a biosimilar referencing Roche’s originator biologic, Herceptin (trastuzumab).

CHMP Gives Positive Opinion on Centus Biotherapeutics’ Bevacizumab Biosimilar

August 13, 2020

The committee has given a positive opinion on the biosimilar bevacizumab for several cancer indications.

Takeda and Novavax Team Up for COVID-19 Vaccine Development in Japan

August 11, 2020

The companies will collaborate on the manufacturing, clinical development, and regulatory activities for Novavax’s COVID-19 vaccine in Japan.

Grand River Selected for Operation Warp Speed Efforts

August 11, 2020

The CDMO will offer capacity for manufacturing and distributing COVID-19 vaccines and therapeutics at its Grand Rapids, MI, fill/finish facility.

Sanofi and GSK to Supply COVID-19 Vaccine to US Government and European Union

August 07, 2020

Sanofi and GlaxoSmithKline have been selected to supply the US government and the European Union with millions of doses of their COVID-19 vaccine candidate.

J&J in $1-Billion Agreement with US Government for 100 Million Doses of Investigational COVID-19 Vaccine

August 07, 2020

The company is working to ensure broad global access to its COVID-19 vaccine candidate, following approval from regulators.

Pfizer and BioNTech to Supply Japan and Canada with mRNA-Based COVID-19 Vaccine Candidate

August 07, 2020

The companies have agreements to supply its mRNA-based COVID-19 vaccine to Japan and Canada, pending regulatory approvals in those countries.

Using Analytical Assays to Ensure Biosimilar Quality

August 05, 2020

The use of analytical assays is crucial for determining that biosimilar critical quality attributes remain on point.

The Impact of SARS-CoV-2 on Biomanufacturing Operations

August 04, 2020

This article presents the results of a survey conducted to gain insight on the impact of the COVID-19 pandemic on biomanufacturing operations.