The COVID-19 pandemic has led to many changes in how pharmaceutical companies develop vaccines.

Combatting Future Viral Threats with Vaccine Advances

More technologies and treatments are emerging for COVID-19—along with new variants.

What’s Next for COVID-19 Vaccines and Variants?

Partnerships formed during the COVID-19 pandemic have provided a platform for change in assay development and transfers.

Key Elements for Assay Transfer Success

Topic

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

Articles

Scientists and policy makers are looking more sharply at the lag in identifying and producing medicines to moderate early infections and to treat seriously ill patients. 

Where Are the Therapeutics to Combat COVID-19?

The EUA is based on positive results from a Phase III trial that showed bamlanivimab and etesevimab together reduced the risk of COVID-19 hospitalizations and death by 70%.

 FDA Grants Emergency Use Authorization to Eli Lilly COVID-19 Antibody Cocktail

EMA has clarified its position on the European approval process of the Sputnik V vaccine. 

EMA Clarifies Position on Sputnik V European Approval Process

Evonik has revealed plans for investment in the short-term expansion of its specialty lipids production, which are used with mRNA-based COVID-19 vaccines. 

Evonik Invests in Additional Lipid Production for mRNA-based Vaccines

The companies will build capacity in Germany that will be ready in 2022 and are exploring options for increasing volume in 2021.

AstraZeneca and IDT Biologika Plan Vaccine Capacity Expansion 

Videos

Lessons learned from the pandemic can advance future biologic drug development and manufacturing.

Pandemic Response Lessons

Representatives of industry organizations discuss crucial business, regulatory, science-based issues facing the industry.

Bio/Pharma Industry: Beyond Politics and the Pandemic

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 considers regulatory flexibility to allow the agency and sponsors to adapt and pivot to changes in coronavirus. 

FDA Outlines Strategy to Address Virus 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.

COVID-19 Update

Combatting Future Viral Threats with Vaccine Advances

What’s Next for COVID-19 Vaccines and Variants?

Key Elements for Assay Transfer Success