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

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Celltrion Group has revealed that EMA's CHMP has issued a positive scientific opinion for regdanvimab (CT-P59)—an anti-COVID-19 monoclonal antibody treatment candidate.

Celltrion Receives a Positive Opinion from CHMP for Regdanvimab

The company has entered into an agreement with the African Vaccine Acquisition Trust for the supply of 220 million doses of its single-shot COVID-19 vaccine for the African Union’s 55 member states beginning in the third quarter of 2021. 

J&J to Supply the African Union with 200 Million Doses of its COVID-19 Vaccine

EMA has approved the manufacturing of drug product for BioNTech’s COVID-19 vaccine, BNT162b2, at BioNTech’s manufacturing site located in Marburg, Germany. 

EMA Approves BioNTech’s COVID-19 Vaccine Manufacturing Site

The agency’s human medicines committee has approved new manufacturing sites for COVID-19 vaccines.





EMA Adopts Recommendations to Increase COVID-19 Vaccine Capacity

EFPIA and Vaccines Europe urge the avoidance of any reactionary measures that could disrupt the production and delivery of COVID-19 vaccines.

EFPIA, Vaccines Europe Emphasize Need to Avoid Reactionary Measures to Vaccine Exports

AstraZeneca has released the results of its primary analysis of the Phase III trial data evaluating its COVID-19 vaccine.

AstraZeneca Confirms Vaccine Efficacy with Phase III Primary Analysis

Roche has revealed the positive topline results from it Phase III trial assessing the investigational antibody cocktail of casirivimab and imdevimab in high-risk non-hospitalized COVID-19 patients.

Phase III Trial Data Demonstrates Potency of Antibody Cocktail Against COVID-19

After releasing US Phase III trial data for AZD1222, more questions have been raised with AstraZeneca concerning potentially outdated information that could provide an incomplete view of efficacy.

AstraZeneca COVID-19 Vaccine Woes Continue as Questions are Raised over US Trial Data 

The agency says that data do not support the use of ivermectin to prevent or treat COVID-19 outside of clinical trials.

EMA Advises Against Use of Ivermectin for COVID-19 Outside of Clinical Trials 

Rena Verma is a Senior Managing Director in FTI Technology’s Information Governance, Privacy and Security Practice. Rena has been providing advisory solutions to Fortune 500 legal departments and law firms in information governance, electronic discovery, legal technology and legal operations for nearly two decades. Rena's clients include some of the largest pharmaceuticals companies, banks, insurance, transportation and technology companies.

To maintain business continuity and employee safety during the pandemic, many companies have begun tracking and maintaining records of employee health information.

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