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The More Things Change: Gene Therapy Reopens Orphan Drug 'Sameness' Debate

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Orphan Exclusivity For Gene Therapies Hinges On Two Big Factors

US FDA draft guidance says that ‘minor differences’ in transgenes and/or vectors won’t be enough for orphan exclusivity, but agency will consider ‘additional features of the final product’ in making the determination.

End Of ‘Phase I’: The Case To Re-Name First-In-Human Oncology Trials

US FDA’s push to re-think oncology dosing should begin by renaming the initial human trials to de-emphasize toxicity, a National Cancer Institute official suggests.

Slow Down To Speed Up: US FDA Presses Cases For Dose Optimization

The US FDA is urging drug companies to abandon traditional approaches to oncology dosing even if it means slowing down early studies. The trade-off should be faster development times overall, FDA says – but sponsors still seem very wary.

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