1. Pink Sheet

After ACIP Gambit, Pfizer, GSK Take RSV Vaccines To US FDA Adcomm

 
• By Sarah Karlin-Smith and Bridget Silverman

The Vaccines and Related Biological Products Advisory Committee is scheduled to consider the RSV vaccine candidates on 28 February and 1 March.

RSV virus
ACIP members preferred a higher age floor for the RSV vaccines in older adults. • Source: Shutterstock

Pfizer Inc. and GSK plc’s respiratory syncytial virus (RSV) vaccines for older adults appear headed for easy US Food and Drug Administration approval, but their use in younger seniors – those 60 to 64 – may be limited by the Centers for Disease Control and Prevention following the most recent Advisory Committee on Immunization Practices on the products.

FDA’s Vaccines and Related Biological Products Advisory Committee will take separate safety and efficacy votes 28 February on Pfizer’s Abrysvo...

More from Vaccines

More from Pink Sheet

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.