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

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

The agency’s safety monitoring plan outlines how information that emerges after the authorization of COVID-19 vaccines will be collected and reviewed.

EMA Issues Safety Monitoring Plan for COVID-19 Vaccines

EDQM announced three new Official Control Authority Batch Release guidelines that describe the tests to be performed by Official Medicines Control Laboratories  in the European Union OCABR Network. 

EDQM Publishes Guidelines on Batch Release for COVID-19 Vaccines

Pfizer and BioNTech’s BNT162b2 shows efficacy of 95%; the companies plan to submit a request, within days, to FDA for an EUA.

Pfizer and BioNTech COVID-19 Vaccine Candidate Meets Endpoints and Achieves Safety Data Milestone 

The announcement comes after the company saw growth and performance in Asia and decided to continue the expansion of biopharmaceutical manufacturing in the region.

Foxx Life Sciences to Open New Headquarters in India

The expansion will feature added capabilities for formulation development via the upgrade of drug product development laboratories and the addition of Gerteis roller compaction equipment for dry granulation processing. 

Lonza to Expand its HPAPI Capabilities at its Florida Site

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


FDA Commits to Transparency in EUA Reviews

The agency recommended treatments for a variety of cancers as well as treatments for glaucoma and influenza.

EMA Recommends Breast Cancer Treatment and Four Other Medicines for Approval

The guidance was published in connection with a safety monitoring plan for COVID-19 vaccines.

EMA Publishes Risk Management Guidance for COVID-19 Vaccines

The agency marked the annual European Antibiotic Awareness Day with the launch of a social media campaign highlighting the prudent use of antibiotics.

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