News & Analysis as of

Manufacturers Life Sciences Human Genes

Hogan Lovells

Negotiating cell, tissue, and gene therapy agreements with health care organizations

Hogan Lovells on

Legal challenges for innovative cell, tissue, and gene therapies (CTGTs) are mainly seen in the still evolving regulatory environment. However, it is also crucial for the manufacture and supply of CTGTs to have agreements in...more

Manatt, Phelps & Phillips, LLP

Delivering Breakthrough Treatments Affordably

Editor’s Note: In a recent webinar, Manatt Health’s Anthony Fiori, Senior Managing Director, and Alex Dworkowitz, Partner, hosted a panel of innovative thought leaders—including Dr. Sanjiv Shah, Chief Medical Officer of...more

MoFo Life Sciences

FDA Finalizes Guidance On Interpretation Of Orphan Drug “Sameness” For Gene Therapy Products

MoFo Life Sciences on

On September 30, 2021, the U.S. Food and Drug Administration (FDA) announced final guidance titled “Interpreting Sameness of Gene Therapy Products under the Orphan Drug Regulations.” The guidance finalizes the January 2020...more

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