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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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US FDA’s June Approval Forecast: Infection Prevention, Cancer And HAE

 
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What Information Does US FDA Need For Stealth’s Elamipretide After CRL?

 
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EMA Touts Faster Global Post-Approval Changes Via Regulatory Reliance

 
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The European Medicines Agency says that a regulatory reliance pilot that it is supporting to speed up assessments of post-approval changes appears to be accelerating evaluation timelines in non-EU countries.

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Semaglutide: EMA Safety Probe Confirms Rare Eye Disorder Risk

 
• By Neena Brizmohun

The EU product information for Novo Nordisk’s semaglutide medicines is to be updated to include non-arteritic anterior ischemic optic neuropathy as a side effect with a frequency of “very rare.”

Infographic: Leqembi – A Geographical Comparison

 
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EU Pharma Reform: Council Proposal A ‘Step In The Right Direction’ But ‘More Work To Be Done’

 
• By Eliza Slawther

Experts from EUCOPE explain why the Council of the EU’s position on the proposed overhaul of the general pharmaceutical legislation could offer more predictability for companies than the commission’s initial offering.