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Ipsen: Early Engagement With Regulators Can Help Biomarker-Driven Drug R&D

 
• By Eliza Slawther

Regulators can help companies to determine which biomarker is right for their development program before starting clinical trials, boosting the chances of success, Ipsen’s head of early development says.

Ideas
• Source: Shutterstock

Drug candidates that are in early development – defined as assets that are in any development stage up to Phase I clinical trials – can benefit pharmaceutical companies looking to acquire molecules ahead of the competition.

Ipsen’s early development team is constantly scouting the market for promising early stage deals and acquisitions, and it looks...

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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.