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Pharmaceutical Industry › Food and Drug Administration (FDA) › Human Genes

Knobbe Martens

The FDA Approves Two New Gene Therapies for the Treatment of Sickle Cell Disease

Knobbe Martens on

On December 8, 2023, the U.S. Food and Drug Administration (FDA) approved two new gene therapies for the treatment of sickle cell disease. The first, Casgevy™ (exagamglogene autotemcel (exa-cel)), is the first-ever approved...more

Manatt, Phelps & Phillips, LLP

Accessing Cell and Gene Therapies : Insights on Coverage, Reimbursement and Emerging Models

Manatt, Phelps & Phillips, LLP on

Over the past five years, cell and gene therapies have increasingly moved from the R&D pipeline to the health care setting, putting lifesaving treatments for certain cancers and genetic diseases within patients’ reach. Over...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

Womble Bond Dickinson

Cancer Vaccines: The Fourth Pillar of Anti-Cancer Therapy?

Womble Bond Dickinson on

Innovative technologies are being deployed to address the Western world’s major killer: cancer. Traditionally, cancer treatment has included surgery, chemotherapy, and radiation, but recently, the development of targeted...more

Proskauer - Minding Your Business

Orphan Drug Exclusivity for CRISPR/Cas-Based Therapeutics

Proskauer - Minding Your Business on

The prospect of genetic engineering using CRISPR (clustered regularly interspaced short palindromic repeats) and CRISPR-associated nucleases (Cas) has long been hailed as a “revolutionary” development in medicine....more

Wilson Sonsini Goodrich & Rosati

FDA Issues Draft Guidance on Determining Sameness of Gene Therapies

Wilson Sonsini Goodrich & Rosati on

Guidance Relevant for Purposes of Determining Orphan Drug Designation and Exclusivity. Finalizes Six Other Gene Therapies. Two "hot" areas in drug development are i) gene therapies, and ii) therapies for orphan diseases....more

Epstein Becker & Green

New Gene Therapy Guidances Signal Anticipated Growth of Product Submissions by FDA

Epstein Becker & Green on

Recognizing that gene therapy products are now a “therapeutic reality” for some patients, the U.S. Food and Drug Administration (“FDA”) recently unveiled six draft guidance documents intended to foster the development of...more

Mintz - Health Care Viewpoints

FDA Releases Series of Gene Therapy Guidance Documents: From Drug Development to Postmarket Monitoring

Mintz - Health Care Viewpoints on

In a highly anticipated step, which had been teased by agency leadership in their public appearances over the past several months, FDA released a series of draft guidance documents pertaining to the development and approval...more

Hogan Lovells

FDA Cleared First DTC Genetic Tests for Health Risks

Hogan Lovells on

Last week, the U.S. Food and Drug Administration (FDA) granted marketing authorization for 23andMe’s Personal Genome Service (PGS) Test for 10 diseases or conditions. This was the first FDA authorization for a...more

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