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How US FDA Explained The Difference Between Approved And EUA Pfizer/BioNTech COVID-19 Vaccine

 
• By Derrick Gingery

When Comirnaty was approved in 2021, the product in the vials was identical, but the agency still had to state that legally they were different without confusing people.

Same but different
The approved Pfizer-BioNTech vaccine, Comirnaty, is not legally the same as the product available under emergency use authorization, even though the products are interchangeable. • Source: Shutterstock

The BLA review of Pfizer Inc./BioNTech SE’s COVID-19 vaccine Comirnaty raised a regulatory question that was easy to answer, but difficult to explain.

In late August 2021, Comirnaty was about to receive full approval for use in adults 16 and older. But the...

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Cidara’s Non-Vaccine Flu Preventive Offers Respite From Vaccine Conflicts

 
• By Bridget Silverman

Cidara's CD388 drug-Fc conjugate received a breakthrough designation as the Phase III ANCHOR trial started for once-per-season prevention of influenza in a higher-risk population.

EU Decision Time For Insmed’s Brensocatib And Sanofi’s Belumosudil

 
• By Eliza Slawther

Insmed’s first-in-class bronchiectasis drug, brensocatib, is among the products that are up for an opinion by the European Medicines Agency’s human medicines committee this week on whether they should be approved for use in the EU.

US FDA Vaccines AdComm Rejoins Influenza Strain Discussion

 
• By Bridget Silverman

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CDC Should Boost Vaccine Monitoring Transparency, Communication - National Academies Report

 
• By Sue Sutter

The Immunization Safety Office leveraged a “coordinated network of complementary surveillance systems” to monitor COVID-19 vaccine risks during the pandemic, but its communications faced challenges and were often intertwined with CDC efforts to promote vaccination, NASEM report finds.

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‘Why We Would Do It Again’ – Gilead & Roche On Pioneering Global Initiative For Manufacturing Change

Gilead and Roche reflect on their experiences with a global initiative that delivered aligned regulatory decisions through joint hybrid inspections and synchronized review of post-approval changes.

Novel Alzheimer’s Drug Blarcamesine Scheduled For High-Stakes EMA Oral Explanation

 
• By Neena Brizmohun

The EMA has scheduled oral explanation meetings this week for Anavex’s blarcamesine and three other products that are nearing the end of the regulatory review cycle. These meetings usually represent the final chance for sponsors to persuade the agency that their product merits approval.

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The British Pharmacopoeia: Setting standards that are trusted worldwide

In this exclusive article with Peter Crowley, Secretary and Scientific Director of the BP Commission, you’ll discover how the BP is preparing for its landmark 2026 edition while strengthening its influence as a global bridge between science, regulation, and industry.