News & Analysis as of

Life Sciences Public Hearing

McDonnell Boehnen Hulbert & Berghoff LLP

PTAB Sets Date for Oral Argument in CRISPR Interference

On April 20th, the Patent Trial and Appeal Board (PTAB) set oral argument in Interference No. 106,155, between Senior Party The Broad Institute, Harvard University, and the Massachusetts Institute of Technology (collectively,...more

Knobbe Martens

FDA to Hold Public Hearing on Biosimilar Action Plan

Knobbe Martens on

On July 18, 2018, the FDA released a Biosimilar Action Plan that is aimed at promoting competition and affordability across the market for biologics and biosimilar products. The Plan uses four key strategies to accomplish...more

Mintz

FDA Convenes Two-Day Public Hearing on Human Cell and Tissue Product Regulatory Paradigm

Mintz on

As stakeholders and watchers of the expansive field of regenerative medicine likely are aware, earlier this year a study published in the peer-reviewed journal Cell Stem Cell reported on the growth of so-called stem cell...more

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