1. Pink Sheet

FDA Oncology Advisory Committee Is Still Pazdur’s Center of Excellence

 
• By Michael McCaughan

Richard Pazdur is moving to a new role in FDA as part of a reorganization driven by the Cancer 'Moonshot.' The most recent Oncologic Drugs Advisory Committee meeting, however, demonstrates that he is still very much in command of cancer drug reviews.

The Oncologic Drugs Advisory Committee’s unanimous rejection of Spectrum’s proposed bladder cancer therapy apaziquone followed a tried-and-true template for cancer drug reviews in the “Breakthrough” era.

A new drug application with clear problems was brought to the meeting largely to allow FDA’s negative review to be...

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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.