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Full US FDA Independent Review Of Janssen Booster Data May Not Continue Post-EUA

 
• By Derrick Gingery

The agency said its booster EUA decision was based on the immunogenicity studies that were submitted.

Vaccine under a magnifying glass
Janssen submitted data from multiple clinical trials involving thousands of patients as part of its booster shot EUA request. • Source: Alamy

The US Food and Drug Administration based its decision to authorize booster shots for the Janssen Biotech Inc. vaccine on the submitted data, but it appears a large swath of the package may not be reviewed.

The FDA on 20 October amended the Janssen COVID-19 vaccine emergency use authorization to allow the second shot without a...

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• By Sue Sutter

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‘Clean Sweep’ Of US CDC Vaccine Committee Puts Kennedy In Driver’s Seat

 
• By Bridget Silverman

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EMA Explores Supporting Drug Development For High Unmet Need Disorder Scleroderma

 
• By Neena Brizmohun

While treatments for scleroderma are in development, none are approved for the condition that is associated with high morbidity and mortality. The European Medicines Agency says guidance on how to design development programs for the disorder is needed.

EMA Nod For First MASH Drug Rezdiffra, Cell Therapy Zemcelpro And 11 Others

 
• By Eliza Slawther

Madrigal Pharmaceuticals’ Rezdiffra is on track to become the first medicine approved in the EU for non-cirrhotic metabolic dysfunction-associated steatohepatitis after the European Medicines Agency recommended that it be granted conditional marketing authorization.

BIO Notebook: Policy Uncertainty Constraining Dealmaking

 
• By Mandy Jackson and Joseph Haas

Highlights from Day Four of the BIO International Convention include policy concerns helping constrain dealmaking, Novartis discussing its approach to partnering, and Generate looking for funding to move into Phase III.