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Covering Breakthroughs: Payors in New Territory

 
• By Laura Helbling and Sue Sutter

FDA has granted more than two dozen “Breakthrough Therapy” designations. Not everyone is sure that’s a great thing. Payors, in particular, are getting “nervous” about what hyperfast development of hyper-expensive therapies will mean.

It seems like FDA’s new “Breakthrough Therapy” pathway has everybody excited.

The agency has received nearly 100 requests to designate pipeline projects as “Breakthroughs,” and had granted more than two dozen...

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More from Market Access

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.