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Life Sciences › CRISPR › Food and Drug Administration (FDA)

ArentFox Schiff

FDA Greenlights Commercialization of Gene-Edited Pig Resistant to Devastating Swine Disease PRRSV

ArentFox Schiff on

On April 30, the US Food and Drug Administration (FDA), approved the use of a gene-edited pig to confer resistance to Porcine Reproductive and Respiratory Syndrome (PRRS), a devastating swine disease....more

Morrison & Foerster LLP

New Plants, Old Frameworks: FDA’s 1992 Policy Applies to Foods Derived from Genome-Edited Plants

Morrison & Foerster LLP on

On February 22, 2024, FDA released a final guidance detailing how foods derived from genome-edited plants fall into FDA’s existing food safety framework and outlining two voluntary consultation processes for developers. The...more

Goodwin

CRISPR Regulatory Updates

Goodwin on

On December 15, 2023, Vertex announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion for the conditional approval of CASGEVY (exagamglogene autotemcel...more

Goodwin

FDA Approves First Cell-Based Therapies for Treatment of Sickle Cell Disease

Goodwin on

On December 8, 2023, the FDA approved the first cell-based gene therapies for the treatment of sickle cell disease (SCD) in patients 12 years and older—Vertex’s CASGEVY and Bluebird’s LYFGENIA.  SCD is a group of inherited...more

Rothwell, Figg, Ernst & Manbeck, P.C.

Gene Therapy Approvals Gain Steam in 2023: FDA Approves First Gene Therapies for Sickle Cell Disease

Rothwell, Figg, Ernst & Manbeck, P.C. on

In a long-awaited milestone in the gene therapy space, the Food and Drug Administration (FDA) approved two gene therapies to cure sickle cell disease (SCD). Soon thereafter these approvals, a key licensing agreement was...more

American Conference Institute (ACI)

[Event] The National Forum on IP Funding and Tech Strategies for Novel Therapeutic Modalities and Gene Therapies - March 21st -...

American Conference Institute (ACI) on

Hosted by American Conference Institute (ACI), the National Forum on IP, Funding and Tech Strategies for Novel Therapeutic Modalities and Gene Therapies will highlight leveraging technology, safeguarding IP, and securing...more

MoFo Life Sciences

FDA Clears Crispr-Edited Cattle For Market Through Abbreviated Procedure: A First For Food-Use Animals

MoFo Life Sciences on

On March 7, 2022, the Center for Veterinary Medicine (CVM) of the U.S. Food and Drug Administration (FDA) determined that Acceligen Inc.’s genome-edited, heat-tolerant cattle, pose a “low risk to humans, animals, the food...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

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