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Genentech’s Siegel: Why Not More Accelerated Approvals In Immunology?

 
• By Emily Hayes

Podcast – A former FDA official now at Genentech, Jeffrey Siegel talks about unmet need in rheumatology and potential opportunities with the agency for speeding things up outside of oncology.

SAN FRANCISCO – Accelerated approval from FDA is rare in immunology, but this is an underutilized pathway that might be further explored in the therapeutic area in the future, Genentech Inc.’s Jeffrey Siegel said in a recent interview.

Go here to listen to the interview:

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EU Sees Unified Pathway For Drug/IVD Studies As Key To Future Research Investment

 
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Woodcock: Do Not Do The Wrong Study, Even If Against US FDA Advice

 
• By Sarah Karlin-Smith

The former CDER director said she tells sponsors not to conduct an FDA-recommended study design or randomized trial if it will not work.

More from R&D

New Drug Procurement Rules Aim To Drive Pharma Investment In Mexico

 
• By Francesca Bruce

Legal experts warn, however, that new Mexican procurement rules are discriminatory and could be challenged in the courts.

EMA Explores Supporting Drug Development For High Unmet Need Disorder Scleroderma

 
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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.