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FDA Questions Accelerated Approval For AstraZeneca’s Olaparib In Ovarian Cancer

 
• By Sue Sutter

Oncologic Drugs Advisory Committee will consider whether the first-in-class PARP inhibitor should come to market on the basis of Phase II data in a subgroup of patients or await results from an ongoing confirmatory study. Agency cites “uncertainties” about validity and magnitude of effect seen in the Phase II trial.

Whether AstraZeneca PLC’s PARP inhibitor olaparib is worthy of approval in ovarian cancer now or instead should await results from an ongoing confirmatory study is the key question up for debate at FDA’s Oncologic Drugs Advisory Committee meeting June 25.

FDA will ask its advisors to vote on whether efficacy and safety data from a single Phase II study in...

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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.

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.

AI Will Bolster, Not Squelch, Patient Voice In Clinical Research, US FDA Says

 
• By Sue Sutter

Artificial intelligence tools used for clinical research should be developed with input from patients and focus on their needs and abilities, FDA experts said.