1. Pink Sheet

Track-And-Trace Will Not Hitch A Ride On The User Fee Train

 
• By Derrick Gingery

Efforts to reach a consensus proposal have been unsuccessful as the bill nears a possible final vote in the House.

FDA user fee reauthorization legislation being reconciled between House and Senate will not include track-and-trace standards, according to several sources.

A last-minute proposal using ideas both industry and FDA supported appears not to have been able to resolve concerns, forcing...

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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.