Emily Marden

1 month ago | outsourcedpharma.com | Emily Marden |Kelly Kasulis Cho |Sidley Austin |Louis Garguilo

By Emily Marden and Kelly Cho, Sidley Austin In recent years, the FDA has communicated a focus on advancing the development of cell and gene therapies (CGT), mirroring industry’s optimism that these therapies can potentially offer durable and targeted treatment options. Such therapies are regulated in the U.S. as biological products by FDA’s CBER and require approval of a biologics license application (BLA) under Section 351 of the Public Health Service Act prior to being marketed.

Jun 7, 2024 | cellandgene.com | Emily Marden |Kelly Kasulis Cho |Bikash Chatterjee |Pharmatech Associates

With additional cell therapy approvals on the horizon, a diverse array of products and platforms are needed to ensure safety and efficacy in manufacturing, increase speed to market, and decrease overall COGS. Join Cell & Gene Live for a digital discussion on the next generation of platforms and innovative technologies. Registration is free thanks to the support of Invetech. Hello Cell & Gene readers,I'm happy to bring you May's most-clicked articles.

Apr 17, 2024 | cellandgene.com | Emily Marden |Kelly Kasulis Cho

By Emily Marden and Kelly Cho, Sidley Austin LLP As most in the biotech industry know, cell and gene therapies (CGT) are regulated in the U.S. as biological products by FDA’s Center for Biologics Research and Evaluation (CBER) and require approval of a biologics license application (BLA) under Section 351 of the Public Health Service Act, prior to being marketed. In recent years, there has been a growing number of INDs each year, indicating the initiation of clinical studies.

Feb 27, 2024 | lexology.com | Sharon Flanagan |Stephen Abreu |Robert Darwin |Carlton Fleming |Frank Rahmani |Meenakshi Datta | +3 more

Our lawyers share the top investment and regulatory trends from last month’s agenda-setting JP Morgan Health Care Conference. We expect an abundance of novel financing structures, investment focus on new disease states, and important new U.S. Food and Drug Administration (FDA) guidance. Regulatory developments in the U.S.: The FDA has issued several new policy documents on issues such as clinical trial design and conduct, affirming the agency’s high bar for approvals.

Sep 27, 2023 | appliedclinicaltrialsonline.com | Emily Marden

Published on: Exploring the implications of FDA’s renewed focus and commitment to expand the use of accelerated approval for gene therapy products. Gene therapies have been talked about for years as having the potential to treat and even cure a wide range of previously intractable diseases, including cystic fibrosis, hemophilia, diabetes and many forms of cancer.