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Jones Day

Blurring the Line Between the Dry and Wet Lab: Joint Inventorship in AI-Assisted Life Science Inventions

Jones Day on

In 2024, not one but two Nobel Prizes (in Chemistry and Physics) were awarded to researchers for their work in artificial intelligence ("AI"). Particularly noteworthy for the life science community is the Nobel Prize in...more

Health Care Compliance Association (HCCA)

‘No More Boutique Studies’: NIH Mulls ‘Stopping Rules,’ Other Changes to Improve Clinical Trials

Health Care Compliance Association (HCCA) on

At some point in the future, NIH may halt funding for clinical trials deemed too underpowered to produce meaningful findings or that fail to meet enrollment goals. To do this, the agency would have to adopt so-called...more

Hogan Lovells

Four new FDA guidances and proposed rule advance biosimilars policy framework

Hogan Lovells on

Yesterday, FDA released a series of guidances that aim to advance the agency’s biosimilars policy framework, along with a proposed rule on the definition of a “biological product,” which incorporates changes made by the...more

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