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Pfizer, Moderna Discussing When To Drop Controls In COVID Vaccine Trials With US Government

 
• By Cathy Kelly

Crossover could happen along with the EUAs, Operation Warp Speed's Slaoui says, or when enough high-priority groups are inoculated, or maybe when the vaccines receive full BLA approval. Whatever officials and sponsors decide, it will create challenges for vaccine candidates still in development.

COVID-19 vaccine
Pfizer, Moderna Vaccines Moving Toward Release

Pfizer Inc. and Moderna, Inc. are working with the US Food and Drug Administration and the Trump Administration’s Operation Warp Speed on when they should allow placebo recipients in their COVID-19 vaccine trials to cross over to the active vaccine, Operation Warp Speed chief science officer Moncef Slaoui said during a press briefing on 18 November.

Pfizer announced completed results from its late stage vaccine trial the same day, and Slaoui noted that Moderna may make...

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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

Unanimous vote on trivalent Southern hemisphere 2025-2026 influenza vaccine composition by US FDA advisory committee agrees with World Health Organization, but committee members want to keep quadrivalent capacity available

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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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.