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First FDA ODAC meeting without Pazdur highlights conceptual challenges with trial

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The advisory committee meeting—the FDA’s first drug-related adcomm in nine months—could have been a “more conceptual discussion” about the design of AstraZeneca’s Phase 3 trial of camizestrant in HER2-negative advanced breast cancer, former cancer regulator Harpreet Singh told BioSpace.

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Federal court blocks mailing of mifepristone

Get your daily dose of health and medicine every weekday with STAT’s free newsletter Morning Rounds. Sign up here.

Good morning and happy Monday. It’s May, and I’m looking at the weather predictions for this week wondering if spring is finally here to stay. Fingers crossed. 

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Get your daily dose of health and medicine every weekday with STAT’s free newsletter Morning Rounds. Sign up here.

Good morning and happy Monday. It’s May, and I’m looking at the weather predictions for this week wondering if spring is finally here to stay. Fingers crossed. 

Read the rest…

Read More

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Gene therapy’s evidence problem—lessons from recent FDA decisions

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Comprehending the spate of recent rejections in the cell and gene therapy space may require looking no further than early-stage clinical trials of candidates from REGENXBIO, Excision BioTherapeutics and Intellia Therapeutics.

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Windward Bio gets $165M to take China-derived drug into Phase 3 asthma trial

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A Swiss biotech with two experimental medicines from China, plus an in-house discovery team, has brought in $165 million to advance into late-stage testing.

The startup, Windward Bio, has raised a …

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